A Phase 3 interventional study of MB-102 and MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) in Kidney Diseases, Kidney Injury and Kidney Failure, sponsored by MediBeacon. Completed at 5 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by MediBeacon · Phase 3, Interventional, and Basic science
The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound. Adults with kidney function ranging from estimated glomerular filtration rate (eGFR) \<120 to >15 mL/min/1.73 m2 and spanning the entire range of human skin colors as defined by the Fitzpatrick Skin Scale (FSS) were included in the study.
The main questions that the study aimed to answer were:
On dosing day, participants had the TGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. When this was completed, participants then received a single dose of MB-102. Blood samples were collected and fluorescent measurements were taken over a 12- or 24-hour (or longer) period, depending upon enrollment group. For those with significant renal compromise, fluorescent measurements were continued until the sensor no longer detected MB-102 in the body. Following completion of the treatment period, participants returned to the study center approximately 1 week later for a safety follow-up visit. Researchers compared the results to see if the transdermal GFR measurements were comparable to the measured plasma GFR.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 149 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →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.
Exclusion Criteria:
A TGFR Reusable Sensor with Disposable Adhesive Ring was placed on participants' chests at least 15 minutes prior to dosing on treatment day, and the MediBeacon Transdermal GFR System was initiated to collect background fluorescence. After the collection of background fluorescence, a single dose of MB-102 (130 mg) was administered intravenously to participants with estimated glomerular filtration rate (eGFR) eGFR ≥ 70 mL/min/1.73 m\^2. Approximately half of the participants had Fitzpatrick Scale Type I, II or III, and half had Type IV, V and VI skin color type. Blood samples and fluorescent measurements were collected over 12 hours.
Drug: MB-102 · Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
A TGFR Reusable Sensor with Disposable Adhesive Ring was placed on participants' chests at least 15 minutes prior to dosing on treatment day, and the MediBeacon Transdermal GFR System was initiated to collect background fluorescence. After the collection of background fluorescence, a single dose of MB-102 (130 mg) was administered intravenously to participants with estimated glomerular filtration rate eGFR \< 70 mL/min/1.73 m\^2. Approximately half of the participants had Fitzpatrick Scale Type I, II or III, and half had Type IV, V and VI skin color type. Blood samples and fluorescent measurements were collected over 24 hours.
Drug: MB-102 · Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
18.6 mg/mL in a 7.0 mL volume administered by intravenous injection over 30 - 60 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 - 60 seconds
Also known as: Relmapirazin
On treatment day, participants had the TGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon® Transdermal GFR Measurement System was initiated to collect background fluorescence. When this was completed, participants received a single dose of MB-102. Fluorescent measurements were collected for 12-24 hours. For those with significant renal compromise, fluorescent measurements were continued until the sensor no longer detected MB-102 in the body.
Correlation of Transdermal Derived Glomerular Filtration Rate (tGFR) to the Plasma-derived Indexed Glomerular Filtration Rate (nGFR)
The performance measure of P30 is defined as the proportion of transdermal derived GFR values that are within 30% of the measured plasma-derived GFR across all participants. The comparison of transdermal derived glomerular filtration rate (tGFR) with respect to the plasma-derived indexed glomerular filtration rate (nGFR) was calculated with a double-sided 97% confidence interval (CI). The performance goal was 0.85, and success for the study was defined as a lower limit of the 97% CI greater than 0.85.
Time frame: Up to 24 hours following the study dose
Number of Participants With Treatment-emergent Adverse Events Associated With MB-102 Administration
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
Number of Participants With Treatment-emergent Adverse Events Associated With the MediBeacon Transdermal GFR Measurement System Device
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
| Milestone | Participants With eGFR ≥ 70 mL/Min/1.73 m^2 | Participants With eGFR < 70 mL/Min/1.73 m^2 |
|---|---|---|
| Started | 84 | 65 |
| Completed | 84 | 65 |
| Not completed | 0 | 0 |
The performance measure of P30 is defined as the proportion of transdermal derived GFR values that are within 30% of the measured plasma-derived GFR across all participants. The comparison of transdermal derived glomerular filtration rate (tGFR) with respect to the plasma-derived indexed glomerular filtration rate (nGFR) was calculated with a double-sided 97% confidence interval (CI). The performance goal was 0.85, and success for the study was defined as a lower limit of the 97% CI greater than 0.85.
| Proportion of tGFR within 30% of nGFR | Participants With eGFR ≥ 70 mL/Min/1.73 m^2 | Participants With eGFR < 70 mL/Min/1.73 m^2 |
|---|---|---|
| Correlation of Transdermal Derived Glomerular Filtration Rate (tGFR) to the Plasma-derived Indexed Glomerular Filtration Rate (nGFR) | 0.950 (0.817 to 0.995) | 0.971 (0.836 to 1.00) |
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.
| Participants | Participants With eGFR ≥ 70 mL/Min/1.73 m^2 | Participants With eGFR < 70 mL/Min/1.73 m^2 |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events Associated With MB-102 Administration | 1 | 1 |
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.
| Participants | Participants With eGFR ≥ 70 mL/Min/1.73 m^2 | Participants With eGFR < 70 mL/Min/1.73 m^2 |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events Associated With the MediBeacon Transdermal GFR Measurement System Device | 0 | 0 |
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 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With eGFR ≥ 70 mL/Min/1.73 m^2 | 0/84 (0%) | 0/84 (0%) | 2/84 (2.4%) |
| Participants With eGFR < 70 mL/Min/1.73 m^2 | 0/65 (0%) | 0/65 (0%) | 5/65 (7.7%) |
| Event | Participants With eGFR ≥ 70 mL/Min/1.73 m^2 | Participants With eGFR < 70 mL/Min/1.73 m^2 |
|---|---|---|
| HYPERTENSIONVascular disorders | 0/84 | 3/65 |
| INJECTION SITE EXTRAVASATIONGeneral disorders | 0/84 | 2/65 |
| HEADACHENervous system disorders | 2/84 | 0/65 |
Safety Population: all participants who enrolled in the study and were dosed with MB-102
| Age, Continuous(years) | Participants With eGFR ≥ 70 mL/Min/1.73 m^2 | Participants With eGFR < 70 mL/Min/1.73 m^2 | Total |
|---|---|---|---|
| Mean | 51.5 ± 12.9 | 66.0 ± 8.62 | 57.8 ± 13.3 |
| Sex: Female, Male(Participants) | Participants With eGFR ≥ 70 mL/Min/1.73 m^2 | Participants With eGFR < 70 mL/Min/1.73 m^2 | Total |
|---|---|---|---|
| Female | 37 | 33 | 70 |
| Male | 47 | 32 | 79 |
| Ethnicity (NIH/OMB)(Participants) | Participants With eGFR ≥ 70 mL/Min/1.73 m^2 | Participants With eGFR < 70 mL/Min/1.73 m^2 | Total |
|---|---|---|---|
| Hispanic or Latino | 34 | 26 | 60 |
| Not Hispanic or Latino | 50 | 39 | 89 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Participants With eGFR ≥ 70 mL/Min/1.73 m^2 | Participants With eGFR < 70 mL/Min/1.73 m^2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 2 | 1 | 3 |
| Black or African American | 26 | 31 | 57 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| White | 52 | 30 | 82 |
| Other | 2 | 2 | 4 |
| Unknown or not reported | 0 | 1 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
MediBeacon