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CompletedNCT02772276Updated Oct 26, 2023Results posted

Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types

A Phase 2 interventional study of MB-102-- single dose of 4 µmol/kg and MB-102-- single dose of 130 mg in Acute Kidney Injury, sponsored by MediBeacon. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-26.

Sponsored by MediBeacon · Phase 2, Interventional, and Basic science

Phase
Phase 2
Study type
Interventional
Enrollment
234
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study was a pilot, safety, and pharmacokinetic study of MB-102 versus iohexol and the use of the non-invasive optical renal function monitor (ORFM) device in normal and compromised renal function participants with different skin color types.

Read the detailed description

The objectives of this study were to evaluate the safety and tolerability of single and multiple doses of MB-102 in participants with normal and impaired kidney function; to determine plasma pharmacokinetics of MB-102 compared to the pharmacokinetics of iohexol in participants with normal and impaired kidney function; to demonstrate that MB-102-transdermal-fluorescence-measured glomerular filtration rate (GFR) using the optical renal function monitor (ORFM) Brilliance device is aligned with MB-102 plasma GFR; to evaluate the safety and effectiveness of the ORFM investigational medical device prototypes QuantumLeap, Radiance, and Brilliance for the non-invasive transdermal fluorescent detection of MB-102 in participants with a range of skin color types; and to determine the optimal dose of MB-102 for non-invasive measurement.

02

Conditions studied

  • Acute Kidney Injury

Keywords

  • Glomerular Filtration Rate
03

In context

Acute Kidney Injury

1,594 studies on the registry are indexed under Acute Kidney Injury; 370 are open to participants now.

This study's enrollment of 234 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

MediBeacon is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Main Criteria for Inclusion (Quantum Leap and Radiance device)

  • Age > 22 years - male or female

    • Eligible female non-pregnant participants who are either not of childbearing potential or willing to use adequate contraception during the trial
    • Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post dose
  • Participants willing to comply with study requirements
  • Participants who have signed an informed consent form
  • Normal or non-clinically significant screening and baseline 12-lead electrocardiogram (ECG) in the opinion of the principal investigator (PI)
  • Adequate venous access sufficient to allow blood sampling per protocol requirements

Main Criteria for Inclusion (Brilliance device)

  • Age > 18 years - male or female

    • Eligible female non-pregnant participants who are either not of childbearing potential or willing to use adequate contraception during the trial
    • Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post dose
  • Participants willing to comply with study requirements
  • Participants who have signed an informed consent form
  • Normal or non-clinically significant screening and baseline 12-lead ECG in the opinion of the PI
  • Adequate venous access sufficient to allow blood sampling per protocol requirements

Normal-CKD Stage 2/QuantumLeap; Normal-CKD Stage 2/Radiance; Normal-CKD Stage 2/Brilliance algorithm optimization; Normal-CKD Stage 2/Brilliance sensor optimization; Normal-CKD Stage 2/Brilliance sensor optimization; and Normal-CKD Stage 2/Brilliance (1-2 sensors)

  • Are healthy as determined by medical history, with no clinically significant findings on screening and baseline physical exams, vital signs and clinical laboratory panels or conditions that could adversely impact the participant's participation or safety, conduct of the study or interfere with study assessments
  • Have estimated glomerular filtration rate (eGFR (Chronic kidney disease - epidemiology collaboration [CKD-EPI] equation) of ≥60 ml/min/1.73m\^2 (normal to Stage 2 CKD) at the time of screening
  • Approximately half of the participants enrolled in each cohort to have Fitzpatrick Scale Type I, II or III skin color type
  • Approximately half of the participants enrolled in each cohort to have Fitzpatrick Type IV, V or VI skin color type.

CKD Stage 3-4/QuantumLeap

  • Possess stable renal function in the opinion of the PI
  • Have eGFR (CKD-EPI equation) of 15 - 59 mL/min/1.73m\^2 at the time of screening

  • Stable use of immunosuppressant medications (when applicable)

    • 15 participants per cohort to have Fitzpatrick Type I, II or III skin color type
    • 15 participants per cohort to have Fitzpatrick Type IV, V or VI skin color type

CKD Stage 3-5/Radiance; CKD Stage 3-5/Brilliance algorithm optimization; CKD Stage 3-5/Brilliance sensor validation; and CKD Stage 3-5/Brilliance 1-2 sensors

  • Possess stable renal function as defined as the most recent historical (within 3 months) eGFR and screening eGFR differing by ≤20%.
  • Have eGFR (CKD-EPI equation) of \<59 mL/min/1.73m\^2 based on a historical value collected within 3 months or from the screening serum creatinine
  • Stable use of immunosuppressant medications (when applicable) defined as no changes in the last 30 days or expected through the follow up visits, and a prednisone dose of \<20 mg/day (or another steroid's equivalent dose)
  • Approximately half of the participants in each cohort to have Fitzpatrick Type I, II or III skin color type
  • Approximately half of the participants in each cohort to have Fitzpatrick Type IV, V or VI skin color type

Exclusion criteria

EXCLUSION CRITERIA

Main Criteria for Exclusion (QuantumLeap device)

  • Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to use a barrier method of birth control
  • Intolerant to venipuncture
  • Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication
  • Participation in another interventional trial within 30 days of screening or concurrently enrolled in any other medical research study which could impact the results of the study
  • History of drug or alcohol abuse within the past year
  • History of allergy or hypersensitivity to MB-102 or iohexol, or other related (iodinated contrast media) products, or any of the inactive ingredients
  • History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the PI, could contraindicate the subject's participation in this study
  • Participants who have allergies to 2 or more classes of drugs. (Intolerance to a drug is not considered a drug allergy)
  • Stable use (no changes within 30 days) of prescription or over the counter (OTC) medications
  • Non-steroidal anti-inflammatory drug (NSAID) use within 2 days of dosing day
  • History of coagulation disorders or bleeding disorders that in the judgement of the investigator places the subject at undue risks for study related procedures
  • Are homozygous for sickle cell disease
  • Have a known thyroid disorder
  • Have pheochromocytoma
  • Currently on Coumadin (warfarin) who have an International normalized ratio (INR) >4 at Screening
  • Current history of AIDS or HIV
  • Hepatitis B antigen positive, or C antibody positive
  • Site personnel immediately associated with the study or their immediate family members
  • Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial
  • Prior enrollment and dosing in this Pilot 2 study
  • Significant scaring, tattoos or alterations in pigmentation on the sternum that would alter sensor readings versus other areas of the skin

Additional Exclusion: Normal-CKD Stage 2/QuantumLeap

  • History of significant cardiovascular disease, heart failure, myocardial infarction in the past 3 months, pulmonary, hematologic, endocrine, hepatobiliary, nephrologic, immunologic, dermatologic, neurologic (including any history of stroke and/or seizure disorder), psychological, musculoskeletal disease, diagnosis of cancer with the past 2 years or deemed clinically significant or unstable by the Principal Investigator; Note: history of gallstones or kidney stones are not excluded so long as the condition is not acute within 30 days of dosing.

Additional Exclusion: CKD Stage 3-4/QuantumLeap

  • Stage 5 CKD at the time of screening
  • Recent (within 3 months) significant medical condition or surgical procedure including myocardial infarction, laparoscopic procedures, or other medical inventions
  • Doses of prednisone greater than 10 mg/day within the last 90 days

Main Criteria for Exclusion: (Radiance device)

  • Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to use a barrier method of birth control

    o Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post dose

  • Unable to have venous access placed in both arms
  • Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication
  • Participation in another interventional trial within 30 days of dosing or concurrently enrolled in any other medical research study which could impact the results of the study
  • History of drug or alcohol abuse within the past year
  • History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
  • History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, MB-102 and iohexol or other related (iodinated contrast media) products (intolerance to a drug is not considered a drug allergy)
  • NSAID use within 2 days of dosing day
  • History of coagulation disorders or bleeding disorders that in the judgement of the investigator places the subject at undue risks for study related procedures
  • Are homozygous for sickle cell disease
  • Have hyperthyroidism or current thyroid cancer
  • Have pheochromocytoma
  • Currently on Coumadin (warfarin) who have an INR >4 at Screening
  • Current history of AIDS or HIV
  • Current evidence of an active Hepatitis B or C infection. If the participant is Hepatitis C antibody positive, but the hepatitis C RNA is below the level of detection, they are considered immune and may be eligible for enrollment.
  • Site personnel immediately associated with the study or their immediate family members
  • Any characteristics which, in the opinion of the investigator, makes the subject a poor candidate for participation in the clinical trial
  • Prior exposure to MB-102
  • Significant scaring, tattoos or alterations in pigmentation on the sternum that would alter sensor readings versus other areas of the skin

Main Criteria for Exclusion: (Brilliance device)

  • Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to use a barrier method of birth control

    o Males must be unwilling to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post dose

  • Unable to have venous access
  • Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication
  • Participation in another interventional trial within 30 days of dosing or concurrently enrolled in any other medical research study which could impact the results of the study
  • History of drug or alcohol abuse within the past year
  • History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
  • History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, or MB-102 (intolerance to a drug is not considered a drug allergy)
  • NSAID use within 2 days of dosing day
  • History of coagulation disorders or bleeding disorders that in the judgement of the investigator places the subject at undue risks for study related procedures
  • Currently on Coumadin (warfarin) who have an INR >4 at Screening
  • Current history of AIDS or HIV
  • Current evidence of an active Hepatitis B or C infection. If the participant is Hepatitis C antibody positive, but the hepatitis C RNA is below the level of detection, they are considered immune and may be eligible for enrollment.
  • Site personnel immediately associated with the study or their immediate family members
  • Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial
  • Significant scaring, tattoos or alterations in pigmentation on the sternum that would alter sensor readings versus other areas of the skin

Additional Exclusion: Normal-CKD Stage 2/Radiance; Normal-CKD Stage 2/Brilliance algorithm optimization; Normal-CKD Stage 2/Brilliance sensor optimization; Normal-CKD Stage 2/Brilliance sensor validation; and Normal-CKD Stage 2/Brilliance (1-2 sensors)

  • History of significant cardiovascular disease, heart failure, myocardial infarction in the past 3 months, or NYHA class III or IV HF
  • Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, or psychiatric condition that in the opinion of the investigator would limit the participant's ability to complete study requirements or may put the subject at increased risk or compromise interpretability of study results. Note: a history of gallstones or kidney stones are not excluded so long as the condition is not acute within 30 days of dosing.

Additional Exclusion: CKD Stage 3-5/Radiance; CKD Stage 3-5/Brilliance algorithm optimization; CKD Stage 3-5/Brilliance sensor validation; and CKD Stage 3-5/Brilliance 1-2 sensors

  • Recent (within 3 months) significant medical condition or surgical procedure including myocardial infarction, thoracic laparoscopic procedures, or other significant medical inventions
  • Received >20 mg/day of prednisone or an equivalent dose of glucocorticoid for more than 7 days in the last 90 days prior to dosing day for an acute or chronic disorder
  • Currently receiving dialysis
  • Currently anuric
05

Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
234 participants (actual)

Study arms

  • Experimental
    Normal-CKD Stage 2/QuantumLeap

    MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

    Drug: MB-102-- single dose of 4 µmol/kg · Drug: Iohexol · Device: QuantumLeap

  • Experimental
    CKD Stage 3-4/QuantumLeap

    MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-4), and fluorescence measured by the QuantumLeap ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. In order to determine the optimal dose of MB-102, participants may have received different doses.

    Drug: MB-102-- single dose of 4 µmol/kg · Drug: Iohexol · Device: QuantumLeap

  • Experimental
    Normal-CKD Stage 2/Radiance

    MB-102 and iohexol administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.

    Drug: MB-102-- single dose of 4 µmol/kg · Drug: Iohexol · Device: Radiance

  • Experimental
    CKD Stage 3-5/Radiance

    MB-102 and iohexol administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Radiance ORFM device. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.

    Drug: MB-102-- single dose of 4 µmol/kg · Drug: Iohexol · Device: Radiance

  • Experimental
    Normal-CKD Stage 2/Brilliance algorithm optimization

    MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.

    Drug: MB-102-- single dose of 4 µmol/kg · Device: Brilliance (1 or 2 sensors)

  • Experimental
    CKD Stage 3-5/Brilliance algorithm optimization

    MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. Algorithm optimization of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.

    Drug: MB-102-- single dose of 4 µmol/kg · Device: Brilliance (1 or 2 sensors)

  • Experimental
    Normal-CKD Stage 2/Brilliance sensor optimization

    MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Sensor optimization of the Brilliance device was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.

    Drug: MB-102-- single dose of 4 µmol/kg · Device: Brilliance (1 or 2 sensors)

  • Experimental
    Normal-CKD Stage 2/Brilliance sensor validation

    MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device. Validation of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.

    Drug: MB-102-- single dose of 4 µmol/kg · Device: Brilliance (1 or 2 sensors)

  • Experimental
    CKD Stage 3-5/Brilliance sensor validation

    MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. Validation of the Brilliance sensor was conducted. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.

    Drug: MB-102-- single dose of 130 mg · Device: Brilliance (1 or 2 sensors)

  • Experimental
    Normal-CKD Stage 2/Brilliance (1-2 sensors)

    MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. A subset of participants in this arm received two doses of MB-102, 12 hours apart.

    Drug: MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart · Device: Brilliance (1 or 2 sensors)

  • Experimental
    Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor)

    MB-102 administered to participants with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors and 2-part sensor). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type. A subset of participants in this arm received two doses of MB-102, 12 hours apart.

    Drug: MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart · Device: Brilliance (1 or 2 sensors) · Device: Brilliance (2-part sensor)

  • Experimental
    Normal-CKD Stage 2/Brilliance (1-2 sensors and Brilliance 2-part sensor) and 2 doses MB-102

    Two doses of MB-102 administered to participants 12 hours apart, with normal to chronic kidney disease (CKD) Stage 2 renal function, and fluorescence measured by the Brilliance ORFM device (1-2 sensors and 2-part sensor). The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.

    Drug: MB-102-- two doses of 130 mg 24 hours apart · Device: Brilliance (1 or 2 sensors) · Device: Brilliance (2-part sensor)

  • Experimental
    CKD Stage 3-5/Brilliance 1-2 sensors

    MB-102 administered to participants with impaired renal function (chronic kidney disease (CKD) Stage 3-5), and fluorescence measured by the Brilliance ORFM device. The optimized algorithm and final device design of the Brilliance device was tested. Approximately half of the participants were to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.

    Drug: MB-102-- single dose of 130 mg · Device: Brilliance (1 or 2 sensors)

Interventions

  • DrugMB-102-- single dose of 4 µmol/kg

    4 µmol/kg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds.

    Also known as: Relmapirazin

  • DrugMB-102-- single dose of 130 mg

    130 mg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds. A subset of participants will receive two doses of MB-102, 12 hours apart.

    Also known as: Relmapirazin

  • DrugMB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart

    130 mg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds.

    Also known as: Relmapirazin

  • DrugMB-102-- two doses of 130 mg 24 hours apart

    4 µmol/kg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds. A subset of participants will receive two doses of MB-102, 12 hours apart.

    Also known as: Relmapirazin

  • DrugIohexol

    5 mL of a 647 mg/mL solution administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds

    Also known as: Omnipaque 300

  • DeviceQuantumLeap

    Optical Renal Function Monitor (ORFM)

  • DeviceRadiance

    Optical Renal Function Monitor (ORFM)

  • DeviceBrilliance (1 or 2 sensors)

    Optical Renal Function Monitor (ORFM)

  • DeviceBrilliance (2-part sensor)

    Optical Renal Function Monitor (ORFM)

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events

    An adverse event is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, temporally associated with the use of a medicinal product, whether or not related to the investigational medical device or drug.

    Time frame: From the time of dosing through the follow-up visit, up to 10 days

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax) of MB-102

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.

    Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

  2. Maximum Plasma Concentration (Cmax) of Iohexol

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.

    Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

  3. Time to Maximum Plasma Concentration (Tmax) of MB-102

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in minutes) was directly determined from the concentration-time data.

    Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

  4. Time to Maximum Plasma Concentration (Tmax) of Iohexol

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in minutes) was directly determined from the concentration-time data.

    Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

  5. The Elimination Half-life of MB-102

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The elimination half-life (the time required for the concentration of the drug to reach half of its original value) was calculated as t1/2 λz= ln(2)/ λz.

    Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

  6. The Elimination Half-life of Iohexol

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The elimination half-life (the time required for the concentration of the drug to reach half of its original value) was calculated as t1/2 λz= ln(2)/ λz.

    Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

  7. Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng\*min/mL) was be estimated from time 0 to the last measurable concentration using noncompartmental analyses.

    Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

  8. Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Iohexol

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng\*min/mL) was be estimated from time 0 to the last measurable concentration using noncompartmental analyses.

    Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

  9. Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng\*min/mL) from time 0 to infinity was calculated as: AUC∞ = AUClast + LQC/λz where LQC is the predicted concentration (based on the terminal regression) at the time of the last measurable concentration.

    Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

  10. Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Iohexol

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng\*min/mL) from time 0 to infinity was calculated as: AUC∞ = AUClast + LQC/λz where LQC is the predicted concentration (based on the terminal regression) at the time of the last measurable concentration.

    Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

  11. Total Plasma Clearance of MB-102

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Total plasma clearance (the volume of plasma cleared of the drug over time) was calculated as: Clp = Dose/ AUC∞.

    Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

  12. Total Plasma Clearance of Iohexol

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Total plasma clearance (the volume of plasma cleared of the drug over time) was calculated as: Clp = Dose/ AUC∞.

    Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

  13. The Terminal Rate Constant for MB-102

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The terminal rate constant (λz) was determined by linear regression of the terminal linear phase of the log plasma concentration-time profile.

    Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

  14. The Terminal Rate Constant for Iohexol

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The terminal rate constant (λz) was determined by linear regression of the terminal linear phase of the log plasma concentration-time profile.

    Time frame: Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.

  15. Renal Clearance of MB-102

    Urine samples were collected pre-dose (time 0) and 5 mL urine samples were collected each time the subject voided. The total volume of urine excreted was recorded until 12 hours post-dose, and was analyzed using validated analytical methods. Renal clearance (the volume of plasma cleared of the drug by the kidneys over time) was calculated as: CLr = Ae/ AUClast, where Ae is the cumulative amount of analyte excreted in urine over the sampling interval.

    Time frame: Pre-dose and each time the participant voids up to 720 minutes post dose

  16. Renal Clearance of Iohexol

    Urine samples were collected pre-dose (time 0) and 5 mL urine samples were collected each time the subject voided. The total volume of urine excreted was recorded until 12 hours post-dose, and was analyzed using validated analytical methods. Renal clearance (the volume of plasma cleared of the drug by the kidneys over time) was calculated as: CLr = Ae/ AUClast, where Ae is the cumulative amount of analyte excreted in urine over the sampling interval.

    Time frame: Pre-dose and each time the participant voids up to 720 minutes post dose

  17. Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Quantum Leap Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the QuantumLeap device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the QuantumLeap device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.

    Time frame: Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose

  18. Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Radiance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and will be analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Radiance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Radiance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.

    Time frame: Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose

  19. Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With Normal-CKD Stage 2 Renal Function

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, and 480 minutes post dose, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Brilliance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Brilliance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.

    Time frame: Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, and 480 minutes post dose

  20. Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With CKD Stage 3-4 Renal Function

    Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) and 960, 1440, 1920, 2400, and 2880 (±30 min) minutes post dose, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Brilliance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Brilliance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.

    Time frame: Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) and 960, 1440, 1920, 2400, and 2880 (±30 min) minutes post dose

  21. Number of Participants With Adverse Events Related to the Use of the QuantumLeap Device

    The number of participants with adverse events related to the use of the QuantumLeap device was documented.

    Time frame: From the time of dosing through the follow-up visit, up to 10 days

  22. Number of Participants With Adverse Events Related to the Use of the Radiance Device

    The number of participants with adverse events related to the use of the Radiance device was documented.

    Time frame: From the time of dosing through the follow-up visit, up to 10 days

  23. Number of Participants With Adverse Events Related to the Use of the Brilliance Device

    The number of participants with adverse events related to the use of the Brilliance device was documented.

    Time frame: From the time of dosing through the follow-up visit, up to 10 days

07

Results

Posted Oct 26, 2023

Participant flow

Participant flow — Overall Study
MilestoneNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/RadianceNormal-CKD Stage 2/Brilliance Algorithm OptimizationCKD Stage 3-5/Brilliance Algorithm OptimizationNormal-CKD Stage 2/Brilliance Sensor OptimizationNormal-CKD Stage 2/Brilliance Sensor ValidationCKD Stage 3-5/Brilliance Sensor ValidationNormal-CKD Stage 2/Brilliance (1-2 Sensors)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102CKD Stage 3-5/Brilliance 1-2 Sensors
Started3129204097183018124412
Completed3129204097172918124412
Not completed0000001100000
Withdrew: Lost to follow-up0000001000000
Withdrew: Withdrew consent0000000100000

Outcome measures

PrimaryNumber of Participants With Treatment-Emergent Adverse Events

An adverse event is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, temporally associated with the use of a medicinal product, whether or not related to the investigational medical device or drug.

Time frame:
From the time of dosing through the follow-up visit, up to 10 days
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events
ParticipantsNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/RadianceNormal-CKD Stage 2/Brilliance Algorithm OptimizationCKD Stage 3-5/Brilliance Algorithm OptimizationNormal-CKD Stage 2/Brilliance Sensor OptimizationNormal-CKD Stage 2/Brilliance Sensor ValidationCKD Stage 3-5/Brilliance Sensor ValidationNormal-CKD Stage 2/Brilliance (1-2 Sensors)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102CKD Stage 3-5/Brilliance 1-2 Sensors
Number of Participants With Treatment-Emergent Adverse Events7721112012112
SecondaryMaximum Plasma Concentration (Cmax) of MB-102

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.

Time frame:
Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Reported as:
Mean · ng/mL
Maximum Plasma Concentration (Cmax) of MB-102
ng/mLNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/RadianceNormal-CKD Stage 2/Brilliance Algorithm OptimizationCKD Stage 3-5/Brilliance Algorithm OptimizationNormal-CKD Stage 2/Brilliance Sensor OptimizationNormal-CKD Stage 2/Brilliance Sensor ValidationCKD Stage 3-5/Brilliance Sensor ValidationNormal-CKD Stage 2/Brilliance (1-2 Sensors)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102CKD Stage 3-5/Brilliance 1-2 Sensors
Maximum Plasma Concentration (Cmax) of MB-10210751.613 ± 2279.369911625.517 ± 2491.430411981.7 ± 2659.956812243.45 ± 2563.573413961.111 ± 3326.506414440.143 ± 3049.76713747.739 ± 2985.467313453.74 ± 3886.933513039.944 ± 3819.844813015.833 ± 2314.246215650 ± 4023.679913125 ± 2818.244111665 ± 3637.8803
SecondaryMaximum Plasma Concentration (Cmax) of Iohexol

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.

Time frame:
Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Reported as:
Mean · ng/mL
Maximum Plasma Concentration (Cmax) of Iohexol
ng/mLNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/Radiance
Maximum Plasma Concentration (Cmax) of Iohexol295967.742 ± 71088.9039290172.414 ± 74285.6788333000 ± 70799.9405329200 ± 98658.229
SecondaryTime to Maximum Plasma Concentration (Tmax) of MB-102

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in minutes) was directly determined from the concentration-time data.

Time frame:
Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Reported as:
Mean · minutes
Time to Maximum Plasma Concentration (Tmax) of MB-102
minutesNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/RadianceNormal-CKD Stage 2/Brilliance Algorithm OptimizationCKD Stage 3-5/Brilliance Algorithm OptimizationNormal-CKD Stage 2/Brilliance Sensor OptimizationNormal-CKD Stage 2/Brilliance Sensor ValidationCKD Stage 3-5/Brilliance Sensor ValidationNormal-CKD Stage 2/Brilliance (1-2 Sensors)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102CKD Stage 3-5/Brilliance 1-2 Sensors
Time to Maximum Plasma Concentration (Tmax) of MB-1027.258 ± 5.29765.862 ± 2.3415.25 ± 1.1185.875 ± 2.23255 ± 06.429 ± 2.43986.111 ± 2.74165.167 ± 0.912912.222 ± 27.01975 ± 05 ± 05 ± 025 ± 67.7227
SecondaryTime to Maximum Plasma Concentration (Tmax) of Iohexol

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in minutes) was directly determined from the concentration-time data.

Time frame:
Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Reported as:
Mean · minutes
Time to Maximum Plasma Concentration (Tmax) of Iohexol
minutesNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/Radiance
Time to Maximum Plasma Concentration (Tmax) of Iohexol9.194 ± 5.3387.069 ± 3.13886.5 ± 2.35086.875 ± 2.7003
SecondaryThe Elimination Half-life of MB-102

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The elimination half-life (the time required for the concentration of the drug to reach half of its original value) was calculated as t1/2 λz= ln(2)/ λz.

Time frame:
Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Reported as:
Mean · minutes
The Elimination Half-life of MB-102
minutesNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/RadianceNormal-CKD Stage 2/Brilliance Algorithm OptimizationCKD Stage 3-5/Brilliance Algorithm OptimizationNormal-CKD Stage 2/Brilliance Sensor OptimizationNormal-CKD Stage 2/Brilliance Sensor ValidationCKD Stage 3-5/Brilliance Sensor ValidationNormal-CKD Stage 2/Brilliance (1-2 Sensors)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102CKD Stage 3-5/Brilliance 1-2 Sensors
The Elimination Half-life of MB-102130.712 ± 33.5894314.267 ± 151.5375135.821 ± 26.0772301.21 ± 183.0147123.681 ± 25.4325245.7 ± 51.3774140.176 ± 22.2139122.86 ± 14.6245305.944 ± 105.6855126.049 ± 20.65147.117 ± 23.779127.842 ± 22.9881440.488 ± 294.5741
SecondaryThe Elimination Half-life of Iohexol

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The elimination half-life (the time required for the concentration of the drug to reach half of its original value) was calculated as t1/2 λz= ln(2)/ λz.

Time frame:
Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Reported as:
Mean · minutes
The Elimination Half-life of Iohexol
minutesNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/Radiance
The Elimination Half-life of Iohexol148.056 ± 38.2236366.529 ± 191.4136151.776 ± 31.4044347.574 ± 214.8895
SecondaryArea Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng\*min/mL) was be estimated from time 0 to the last measurable concentration using noncompartmental analyses.

Time frame:
Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Reported as:
Mean · ng*min/mL
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-102
ng*min/mLNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/RadianceNormal-CKD Stage 2/Brilliance Algorithm OptimizationCKD Stage 3-5/Brilliance Algorithm OptimizationNormal-CKD Stage 2/Brilliance Sensor OptimizationNormal-CKD Stage 2/Brilliance Sensor ValidationCKD Stage 3-5/Brilliance Sensor ValidationNormal-CKD Stage 2/Brilliance (1-2 Sensors)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102CKD Stage 3-5/Brilliance 1-2 Sensors
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for MB-1021131336.448 ± 254801.42552419911.379 ± 708114.71041211931.882 ± 296491.14692467846.174 ± 843410.96651121973.694 ± 190118.85912560133.925 ± 519858.57381235178.035 ± 310587.53361072786.062 ± 281421.34812476458.456 ± 543445.2591384887.303 ± 345784.14691488269.994 ± 108723.60821316506.556 ± 314196.04363678411.381 ± 1344727.8138
SecondaryArea Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Iohexol

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng\*min/mL) was be estimated from time 0 to the last measurable concentration using noncompartmental analyses.

Time frame:
Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Reported as:
Mean · ng*min/mL
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Iohexol
ng*min/mLNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/Radiance
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Iohexol33329159.548 ± 7909842.863958097567.569 ± 15177720.41936677146.278 ± 10789963.95670005450.758 ± 30243153.821
SecondaryArea Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng\*min/mL) from time 0 to infinity was calculated as: AUC∞ = AUClast + LQC/λz where LQC is the predicted concentration (based on the terminal regression) at the time of the last measurable concentration.

Time frame:
Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Reported as:
Mean · ng*min/mL
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-102
ng*min/mLNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/RadianceNormal-CKD Stage 2/Brilliance Algorithm OptimizationCKD Stage 3-5/Brilliance Algorithm OptimizationNormal-CKD Stage 2/Brilliance Sensor OptimizationNormal-CKD Stage 2/Brilliance Sensor ValidationCKD Stage 3-5/Brilliance Sensor ValidationNormal-CKD Stage 2/Brilliance (1-2 Sensors)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102CKD Stage 3-5/Brilliance 1-2 Sensors
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for MB-1021166655.776 ± 298807.35873212036.698 ± 1490329.18081242760.175 ± 321230.06723045719.769 ± 1625406.44541182254.364 ± 208571.16692914852.088 ± 684490.51061264462.94 ± 333601.0381086390.141 ± 287588.98953135394.594 ± 1051071.5971403855.606 ± 355269.44451518516.431 ± 106177.22011340051.2 ± 332392.64943844963.027 ± 1630799.1909
SecondaryArea Under the Plasma Concentration-time Curve From Time Zero to Infinity for Iohexol

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng\*min/mL) from time 0 to infinity was calculated as: AUC∞ = AUClast + LQC/λz where LQC is the predicted concentration (based on the terminal regression) at the time of the last measurable concentration.

Time frame:
Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Reported as:
Mean · ng*min/mL
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Iohexol
ng*min/mLNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/Radiance
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Iohexol34688858.452 ± 9029243.552981061044.851 ± 37977572.64138032869.839 ± 11788838.13690107803.206 ± 61220389.979
SecondaryTotal Plasma Clearance of MB-102

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Total plasma clearance (the volume of plasma cleared of the drug over time) was calculated as: Clp = Dose/ AUC∞.

Time frame:
Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Reported as:
Mean · mL/minute
Total Plasma Clearance of MB-102
mL/minuteNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/RadianceNormal-CKD Stage 2/Brilliance Algorithm OptimizationCKD Stage 3-5/Brilliance Algorithm OptimizationNormal-CKD Stage 2/Brilliance Sensor OptimizationNormal-CKD Stage 2/Brilliance Sensor ValidationCKD Stage 3-5/Brilliance Sensor ValidationNormal-CKD Stage 2/Brilliance (1-2 Sensors)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102CKD Stage 3-5/Brilliance 1-2 Sensors
Total Plasma Clearance of MB-102110.719 ± 28.247651.741 ± 21.4424102.361 ± 31.883551.322 ± 26.2932103.107 ± 17.153244.677 ± 13.79897.496 ± 18.6913117.913 ± 39.447242.838 ± 13.128499.216 ± 33.019684.29 ± 5.037697.741 ± 23.516338.736 ± 13.87
SecondaryTotal Plasma Clearance of Iohexol

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Total plasma clearance (the volume of plasma cleared of the drug over time) was calculated as: Clp = Dose/ AUC∞.

Time frame:
Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Reported as:
Mean · mL/minute
Total Plasma Clearance of Iohexol
mL/minuteNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/Radiance
Total Plasma Clearance of Iohexol97.596 ± 22.602647.418 ± 19.986790.788 ± 25.764145.963 ± 19.1755
SecondaryThe Terminal Rate Constant for MB-102

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The terminal rate constant (λz) was determined by linear regression of the terminal linear phase of the log plasma concentration-time profile.

Time frame:
Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Reported as:
Mean · 1/minutes
The Terminal Rate Constant for MB-102
1/minutesNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/RadianceNormal-CKD Stage 2/Brilliance Algorithm OptimizationCKD Stage 3-5/Brilliance Algorithm OptimizationNormal-CKD Stage 2/Brilliance Sensor OptimizationNormal-CKD Stage 2/Brilliance Sensor ValidationCKD Stage 3-5/Brilliance Sensor ValidationNormal-CKD Stage 2/Brilliance (1-2 Sensors)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102CKD Stage 3-5/Brilliance 1-2 Sensors
The Terminal Rate Constant for MB-1020.006 ± 0.00120.003 ± 0.0010.005 ± 0.00090.003 ± 0.00120.006 ± 0.0010.003 ± 0.00070.005 ± 0.00080.006 ± 0.00060.003 ± 0.00090.006 ± 0.00090.005 ± 0.00080.006 ± 0.00090.002 ± 0.0007
SecondaryThe Terminal Rate Constant for Iohexol

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. The terminal rate constant (λz) was determined by linear regression of the terminal linear phase of the log plasma concentration-time profile.

Time frame:
Pre-dose and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose.
Reported as:
Mean · 1/minutes
The Terminal Rate Constant for Iohexol
1/minutesNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/Radiance
The Terminal Rate Constant for Iohexol0.005 ± 0.0010.002 ± 0.00090.005 ± 0.00090.002 ± 0.0008
SecondaryRenal Clearance of MB-102

Urine samples were collected pre-dose (time 0) and 5 mL urine samples were collected each time the subject voided. The total volume of urine excreted was recorded until 12 hours post-dose, and was analyzed using validated analytical methods. Renal clearance (the volume of plasma cleared of the drug by the kidneys over time) was calculated as: CLr = Ae/ AUClast, where Ae is the cumulative amount of analyte excreted in urine over the sampling interval.

Time frame:
Pre-dose and each time the participant voids up to 720 minutes post dose
Reported as:
Mean · mL/minute
Renal Clearance of MB-102
mL/minuteNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/RadianceNormal-CKD Stage 2/Brilliance Algorithm OptimizationCKD Stage 3-5/Brilliance Algorithm OptimizationNormal-CKD Stage 2/Brilliance Sensor OptimizationNormal-CKD Stage 2/Brilliance Sensor ValidationCKD Stage 3-5/Brilliance Sensor ValidationNormal-CKD Stage 2/Brilliance (1-2 Sensors)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102CKD Stage 3-5/Brilliance 1-2 Sensors
Renal Clearance of MB-102111.396 ± 27.997352.171 ± 21.825104.008 ± 32.362251.915 ± 26.3905105.144 ± 19.203145.397 ± 14.176699.072 ± 19.0079120.452 ± 40.093742.51 ± 12.9745109.924 ± 35.573388.795 ± 3.2184103.774 ± 24.910838.373 ± 13.0747
SecondaryRenal Clearance of Iohexol

Urine samples were collected pre-dose (time 0) and 5 mL urine samples were collected each time the subject voided. The total volume of urine excreted was recorded until 12 hours post-dose, and was analyzed using validated analytical methods. Renal clearance (the volume of plasma cleared of the drug by the kidneys over time) was calculated as: CLr = Ae/ AUClast, where Ae is the cumulative amount of analyte excreted in urine over the sampling interval.

Time frame:
Pre-dose and each time the participant voids up to 720 minutes post dose
Reported as:
Mean · mL/minute
Renal Clearance of Iohexol
mL/minuteNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/Radiance
Renal Clearance of Iohexol98.548 ± 22.523947.909 ± 20.181692.258 ± 26.540146.109 ± 19.4391
SecondaryCorrelation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Quantum Leap Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the QuantumLeap device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the QuantumLeap device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.

Time frame:
Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose
Reported as:
Mean · Coefficient of determination, r-squared
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Quantum Leap Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase
Coefficient of determination, r-squaredNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeap
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Quantum Leap Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase-0.999 ± 0.0009-0.998 ± 0.0028
SecondaryCorrelation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Radiance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose, and will be analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Radiance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Radiance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.

Time frame:
Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) minutes post dose
Reported as:
Mean · Coefficient of determination, r-squared
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Radiance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase
Coefficient of determination, r-squaredNormal-CKD Stage 2/RadianceCKD Stage 3-5/Radiance
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Radiance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase-0.999 ± 0.001-0.998 ± 0.0033
SecondaryCorrelation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With Normal-CKD Stage 2 Renal Function

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, and 480 minutes post dose, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Brilliance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Brilliance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.

Time frame:
Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, and 480 minutes post dose
Reported as:
Mean · Coefficient of determination, r-squared
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With Normal-CKD Stage 2 Renal Function
Coefficient of determination, r-squaredNormal-CKD Stage 2/Brilliance Algorithm OptimizationNormal-CKD Stage 2/Brilliance Sensor OptimizationNormal-CKD Stage 2/Brilliance Sensor ValidationNormal-CKD Stage 2/Brilliance (1-2 Sensors)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With Normal-CKD Stage 2 Renal Function-0.994 ± 0.0092-0.998 ± 0.0026-0.999 ± 0.0015-0.997 ± 0.0037-0.999 ± 0.0015-1 ± 0.0001
SecondaryCorrelation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With CKD Stage 3-4 Renal Function

Blood samples were collected pre-dose (time 0) and at 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) and 960, 1440, 1920, 2400, and 2880 (±30 min) minutes post dose, and were analyzed using validated analytical methods. Transdermal fluorescence intensity at the time of blood sampling as measured by the Brilliance device was documented, and the correlation between the transdermal fluorescence intensity of MB-102 as measured by the Brilliance device and the plasma concentration of MB-102 at each time point in the renal excretion phase was calculated.

Time frame:
Pre-dose (time 0) and 5, 10, 15; (± 1 or 2 min), 30, 60, 90, 120, 180, 240, 300 (±5 min), 360, 480, 600 and 720 (±10 min) and 960, 1440, 1920, 2400, and 2880 (±30 min) minutes post dose
Reported as:
Mean · Coefficient of determination, r-squared
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With CKD Stage 3-4 Renal Function
Coefficient of determination, r-squaredCKD Stage 3-5/Brilliance Algorithm OptimizationCKD Stage 3-5/Brilliance Sensor ValidationCKD Stage 3-5/Brilliance 1-2 Sensors
Correlation Between the Transdermal Fluorescence Intensity of MB-102 as Measured by the Brilliance Device and Plasma Concentration of MB-102 at Each Time Point in the Renal Excretion Phase in Participants With CKD Stage 3-4 Renal Function-0.999 ± 0.0015-0.998 ± 0.0018-0.993 ± 0.0193
SecondaryNumber of Participants With Adverse Events Related to the Use of the QuantumLeap Device

The number of participants with adverse events related to the use of the QuantumLeap device was documented.

Time frame:
From the time of dosing through the follow-up visit, up to 10 days
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events Related to the Use of the QuantumLeap Device
ParticipantsNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeap
Number of Participants With Adverse Events Related to the Use of the QuantumLeap Device40
SecondaryNumber of Participants With Adverse Events Related to the Use of the Radiance Device

The number of participants with adverse events related to the use of the Radiance device was documented.

Time frame:
From the time of dosing through the follow-up visit, up to 10 days
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events Related to the Use of the Radiance Device
ParticipantsNormal-CKD Stage 2/RadianceCKD Stage 3-5/Radiance
Number of Participants With Adverse Events Related to the Use of the Radiance Device10
SecondaryNumber of Participants With Adverse Events Related to the Use of the Brilliance Device

The number of participants with adverse events related to the use of the Brilliance device was documented.

Time frame:
From the time of dosing through the follow-up visit, up to 10 days
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events Related to the Use of the Brilliance Device
ParticipantsNormal-CKD Stage 2/Brilliance Algorithm OptimizationCKD Stage 3-5/Brilliance Algorithm OptimizationNormal-CKD Stage 2/Brilliance Sensor OptimizationNormal-CKD Stage 2/Brilliance Sensor ValidationCKD Stage 3-5/Brilliance Sensor ValidationNormal-CKD Stage 2/Brilliance (1-2 Sensors)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102CKD Stage 3-5/Brilliance 1-2 Sensors
Number of Participants With Adverse Events Related to the Use of the Brilliance Device002000000

Adverse events

Collected over Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Normal-CKD Stage 2/QuantumLeap0/31 (0%)0/31 (0%)7/31 (22.6%)
CKD Stage 3-4/QuantumLeap0/29 (0%)0/29 (0%)5/29 (17.2%)
Normal-CKD Stage 2/Radiance0/20 (0%)0/20 (0%)2/20 (10%)
CKD Stage 3-5/Radiance0/40 (0%)0/40 (0%)0/40 (0%)
Normal-CKD Stage 2/Brilliance Algorithm Optimization0/9 (0%)0/9 (0%)1/9 (11.1%)
CKD Stage 3-5/Brilliance Algorithm Optimization0/7 (0%)0/7 (0%)1/7 (14.3%)
Normal-CKD Stage 2/Brilliance Sensor Optimization0/18 (0%)0/18 (0%)2/18 (11.1%)
Normal-CKD Stage 2/Brilliance Sensor Validation0/30 (0%)0/30 (0%)0/30 (0%)
CKD Stage 3-5/Brilliance Sensor Validation0/18 (0%)0/18 (0%)1/18 (5.6%)
Normal-CKD Stage 2/Brilliance (1-2 Sensors)0/12 (0%)0/12 (0%)2/12 (16.7%)
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)0/4 (0%)0/4 (0%)1/4 (25%)
Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-1020/4 (0%)0/4 (0%)1/4 (25%)
CKD Stage 3-5/Brilliance 1-2 Sensors0/12 (0%)0/12 (0%)2/12 (16.7%)
Most frequent other events
Showing 10 of 11
Most frequent other events
EventNormal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/RadianceNormal-CKD Stage 2/Brilliance Algorithm OptimizationCKD Stage 3-5/Brilliance Algorithm OptimizationNormal-CKD Stage 2/Brilliance Sensor OptimizationNormal-CKD Stage 2/Brilliance Sensor ValidationCKD Stage 3-5/Brilliance Sensor ValidationNormal-CKD Stage 2/Brilliance (1-2 Sensors)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102CKD Stage 3-5/Brilliance 1-2 Sensors
Injection site extravasationGeneral disorders0/310/290/200/400/90/70/180/301/182/121/41/41/12
Oropharyngeal painRespiratory, thoracic and mediastinal disorders0/310/290/200/400/90/70/180/300/180/120/41/40/12
RashSkin and subcutaneous tissue disorders0/311/290/200/400/91/70/180/300/180/120/40/40/12
Application site discolorationGeneral disorders0/310/290/200/400/90/72/180/300/180/120/40/40/12
Hot flushVascular disorders0/310/290/200/401/90/70/180/300/180/120/40/40/12
HeadacheNervous system disorders1/311/290/200/400/90/70/180/300/180/120/40/41/12
Oedema peripheralGeneral disorders1/312/290/200/400/90/70/180/300/180/120/40/40/12
NauseaGastrointestinal disorders2/310/290/200/400/90/70/180/300/180/120/40/40/12
Application site erythemaGeneral disorders2/310/291/200/400/90/70/180/300/180/120/40/40/12
Injection site bruisingGeneral disorders2/311/290/200/400/90/70/180/300/180/120/40/40/12

Baseline characteristics

Safety Analysis Set: all participants who signed the informed consent form and received study drug

Age, Continuous
Age, Continuous(years)Normal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/RadianceNormal-CKD Stage 2/Brilliance Algorithm OptimizationCKD Stage 3-5/Brilliance Algorithm OptimizationNormal-CKD Stage 2/Brilliance Sensor OptimizationNormal-CKD Stage 2/Brilliance Sensor ValidationCKD Stage 3-5/Brilliance Sensor ValidationNormal-CKD Stage 2/Brilliance (1-2 Sensors)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102CKD Stage 3-5/Brilliance 1-2 SensorsTotal
Mean40.3 ± 11.7858.2 ± 11.7654.7 ± 13.5761.1 ± 12.9346.9 ± 13.4066.9 ± 6.6741.6 ± 15.4239.1 ± 15.3870.9 ± 8.0947.9 ± 17.7052.3 ± 14.2742.5 ± 13.7270.3 ± 9.4653 ± 16.7
Sex: Female, Male
Sex: Female, Male(Participants)Normal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/RadianceNormal-CKD Stage 2/Brilliance Algorithm OptimizationCKD Stage 3-5/Brilliance Algorithm OptimizationNormal-CKD Stage 2/Brilliance Sensor OptimizationNormal-CKD Stage 2/Brilliance Sensor ValidationCKD Stage 3-5/Brilliance Sensor ValidationNormal-CKD Stage 2/Brilliance (1-2 Sensors)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102CKD Stage 3-5/Brilliance 1-2 SensorsTotal
Female191410212681666124115
Male12151019711014126328119
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Normal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/RadianceNormal-CKD Stage 2/Brilliance Algorithm OptimizationCKD Stage 3-5/Brilliance Algorithm OptimizationNormal-CKD Stage 2/Brilliance Sensor OptimizationNormal-CKD Stage 2/Brilliance Sensor ValidationCKD Stage 3-5/Brilliance Sensor ValidationNormal-CKD Stage 2/Brilliance (1-2 Sensors)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102CKD Stage 3-5/Brilliance 1-2 SensorsTotal
American Indian or Alaska Native00200000000002
Asian10000000000001
Native Hawaiian or Other Pacific Islander00000000000000
Black or African American1511715427111622487
White15181125551119176228144
More than one race00000000000000
Unknown or Not Reported00000000000000
Region of Enrollment
Region of Enrollment(Participants)Normal-CKD Stage 2/QuantumLeapCKD Stage 3-4/QuantumLeapNormal-CKD Stage 2/RadianceCKD Stage 3-5/RadianceNormal-CKD Stage 2/Brilliance Algorithm OptimizationCKD Stage 3-5/Brilliance Algorithm OptimizationNormal-CKD Stage 2/Brilliance Sensor OptimizationNormal-CKD Stage 2/Brilliance Sensor ValidationCKD Stage 3-5/Brilliance Sensor ValidationNormal-CKD Stage 2/Brilliance (1-2 Sensors)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor)Normal-CKD Stage 2/Brilliance (1-2 Sensors and Brilliance 2-part Sensor) and 2 Doses MB-102CKD Stage 3-5/Brilliance 1-2 SensorsTotal
United States3129204097183018124412234
08

Study locations

3 sites
  • Riverside Clinical Research
    Edgewater, Florida 32132, United States
  • Orlando Clinical Research Center
    Orlando, Florida 32809, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 18, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02772276
Lead sponsor
MediBeacon
Responsible party
Sponsor
First posted
May 13, 2016
Start date
May 11, 2016
Primary completion
Aug 4, 2021
Completion
Aug 4, 2021
Results posted
Oct 26, 2023
Last update
Oct 26, 2023

Study contacts

Richard B Dorshow, PhD
study director · MediBeacon, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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