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CompletedNCT03847909PHYOX2Updated May 22, 2024Results posted

A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2

A Phase 2 interventional study of DCR-PHXC and Sterile Normal Saline (0.9% NaCl) in Primary Hyperoxaluria Type 1 (PH1), Primary Hyperoxaluria Type 2 (PH2) and Kidney Diseases, sponsored by Novo Nordisk A/S. Completed at 28 sites in 15 countries. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2024-05-22.

Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
6 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy and safety of DCR-PHXC in Children and Adults with Primary Hyperoxaluria Type 1 (PH1) and Primary Hyperoxaluria Type 2 (PH2)

02

Conditions studied

  • Primary Hyperoxaluria Type 1 (PH1)
  • Primary Hyperoxaluria Type 2 (PH2)
  • Kidney Diseases
  • Urologic Diseases
  • Genetic Disease

Keywords

  • PH1
  • PH2
  • Primary Hyperoxaluria
  • RNAi
  • RNAi therapeutic
  • GalNAc
  • LDHA gene
  • LDH
  • siRNA
03

In context

Kidney Diseases

3,843 studies on the registry are indexed under Kidney Diseases; 492 are open to participants now.

This study's enrollment of 35 is below the median of 70 across 2,645 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,400 studies on the registry; 102 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.

Browse Novo Nordisk A/S studies →

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

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Capable and willing to provide written informed consent or assent
  • Documented diagnosis of PH1 or PH2, confirmed by genotyping
  • Must meet the 24 hour urine oxalate excretion requirements
  • Less than 20% variation between the two 24-hour urinary creatinine excretion values derived from the two 24-hour urine collections in the screening period
  • Estimated GFR at screening ≥ 30 mL/min normalized to 1.73 m2 BSA

Key Exclusion Criteria:

  • Renal or hepatic transplantation (prior or planned within the study period)
  • Currently on dialysis or anticipated requirement for dialysis during the study period
  • Plasma oxalate >30 µmol/L
  • Documented evidence of clinical manifestations of systemic oxalosis (including pre-existing retinal, heart, or skin calcifications, or history of severe bone pain, pathological fractures, or bone deformations)
  • Use of an RNA interference (RNAi) drug within the last 6 months
  • Participation in any clinical study in which you received an investigational medicinal product (IMP) within 4 months before Screening
  • Liver function test (LFT) abnormalities: Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5 times upper limit of normal (ULN) for age and gender
  • Inability or unwillingness to comply with study procedures
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    DCR-PHXC

    Intervention, drug, DCR-PHXC

    Drug: DCR-PHXC

  • Placebo comparator
    Placebo - Sterile Normal Saline (0.9% NaCl)

    Placebo, sterile normal saline (0.9% NaCl) for subcutaneous (SC) injection

    Drug: Sterile Normal Saline (0.9% NaCl)

Interventions

  • DrugDCR-PHXC

    Multiple fixed doses of DCR-PHXC by subcutaneous (SC) injection

    Also known as: nedosiran

  • DrugSterile Normal Saline (0.9% NaCl)

    Sterile Normal Saline (0.9% NaCl) for subcutaneous (SC) injection, administered at same injection volume as DCR-PHXC, to serve as placebo

06

What researchers measure

Primary outcomes

  1. AUC From Day 90 To Day 180, Based on Percent Change From Baseline in 24-Hour Uox

    The AUC of 24-hour urinary oxalate (Uox) from Day 90 to Day 180, based on percent change from baseline, was compared between the active treatment group and placebo group. A multiple imputation approach was used to handle missing Uox data and then calculate the AUC.

    Time frame: From Day 90 to 180

Secondary outcomes

  1. Percentage of Participants Whose 24-hour Uox Values Normalized or Near-normalized on at Least 2 Consecutive Visits

    Percentage of participants whose 24-hour Uox values normalized or near-normalized on at least 2 consecutive visits are presented. Normalization of Uox was defined as less than (\<) 0.46 millimole per 24 hours (mmol/24 hours) and near normalization was defined as greater than or equal to (\>=) 0.46 to \< 0.60 mmol/24 hours (values adjusted per 1.73 square meter \[1.73 m\^2\] body surface area \[BSA\] in participants aged \<18 years).

    Time frame: From Day 90 to 180

  2. Percent Change From Baseline to Day 180 in the Summed Surface Area of Kidney Stones

    Percent change from baseline to Day 180 in the summed surface area measured in millimetre square (mm\^2) of kidney stones is presented.

    Time frame: Baseline, Day 180

  3. Percent Change From Baseline to Day 180 in the Number of Kidney Stones

    Percent change from baseline to Day 180 in the number of kidney stones is presented.

    Time frame: Baseline, Day 180

  4. Percent Change From Baseline to Day 180 in Plasma Oxalate (For Adults Only)

    Percent change from baseline to Day 180 in plasma oxalate (for adults only) is presented.

    Time frame: Baseline, Day 180

  5. Rate of Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Day 180

    Monthly rate of eGFR change is presented. eGFR was calculated using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and creatinine-based equation.

    Time frame: Baseline, Day 180

  6. Number of Treatment Emergent Adverse Events (TEAEs) And Serious Treatment Emergent Adverse Events (TEAEs)

    Number of TEAEs and TESAEs are presented. An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalisation, results in persistent disability/incapacity or is a congenital anomaly/birth defect. TEAE was defined as any AE with an onset date/time on or after administration (including any partial administration) of the first dose of study intervention and through the study completion date from the end of study case report form (CRF).

    Time frame: From Baseline up to Day 180

  7. Change From Baseline in Electrocardiogram (ECG): Heart Rate

    Change from baseline in heart rate is presented.

    Time frame: Baseline, Day 180

  8. Change From Baseline in ECG: PR Interval, QRS Duration, QT Interval, QTcB Interval, QTcF Interval and RR Interval

    Change from baseline in PR interval, QRS duration, QT interval, QTcB interval, QTcF interval and RR interval is presented.

    Time frame: Baseline, Day 180

  9. Number of Participants With Most Abnormal Post-Baseline Shift in Physical Examination

    Number of participants who had most abnormal post-baseline shift in physical examination are presented. Physical examination shifts were categories into 4 categories: 1) missing; 2) normal; 3) abnormal-not clinically significant (NCS) and 4) abnormal-clinically significant (CS). Each category was presented according body systems including: 1) eyes, ears, nose and throat; 2) chest/respiratory; 3) heart/cardiovascular; 4) gastrointestinal/liver; 5) musculoskeletal/extremities; 6) dermatological/skin; 7) thyroid/neck; 8) lymph nodes; 9) neurological.

    Time frame: Baseline up to Day 180

  10. Change From Baseline in Vital Signs: Height

    Change from baseline to Day 180 in height is presented.

    Time frame: Baseline, Day 180

  11. Change From Baseline in Vital Signs: Weight

    Change from baseline to Day 180 in weight is presented.

    Time frame: Baseline, Day 180

  12. Change From Baseline in Vital Signs: Body Mass Index (BMI)

    Change from baseline to Day 180 in BMI is presented.

    Time frame: Baseline, Day 180

  13. Change From Baseline in Vital Signs: Oral Body Temperature

    Change from baseline to Day 180 in oral body temperature is presented.

    Time frame: Baseline, Day 180

  14. Change From Baseline in Vital Signs: Heart Rate

    Change from baseline to Day 180 in heart rate is presented.

    Time frame: Baseline, Day 180

  15. Change From Baseline in Vital Signs: Respiratory Rate

    Change from baseline to Day 180 in respiratory rate is presented.

    Time frame: Baseline, Day 180

  16. Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure

    Change from baseline to Day 180 in systolic and diastolic blood pressure is presented.

    Time frame: Baseline, Day 180

  17. Change From Baseline in Clinical Chemistry Laboratory Tests: Alanine Aminotransferase, Aspartate Aminotransferase, Glutamate Dehydrogenase, Gamma Glutamyl Transferase, Alkaline Phosphatase, Lactate Dehydrogenase and Creatine Kinase

    Change from baseline to Day 180 in alanine aminotransferase, aspartate aminotransferase, glutamate dehydrogenase, gamma glutamyl transferase, alkaline phosphatase, lactate dehydrogenase and creatine kinase are presented.

    Time frame: Baseline, Day 180

  18. Change From Baseline in Clinical Chemistry Laboratory Tests: Bilirubin, Direct Bilirubin and Creatinine

    Change from baseline to Day 180 in bilirubin, direct bilirubin and creatinine are presented.

    Time frame: Baseline, Day 180

  19. Change From Baseline in Clinical Chemistry Laboratory Tests: Protein, Albumin

    Change from baseline to Day 180 in protein and albumin are presented.

    Time frame: Baseline, Day 180

  20. Change From Baseline in Clinical Chemistry Laboratory Tests: Sodium, Chloride, Potassium and Urea

    Change from baseline to Day 180 in sodium, chloride, potassium and urea are presented.

    Time frame: Baseline, Day 180

  21. Change From Baseline in Clinical Chemistry Laboratory Tests: Vitamin B6

    Change from baseline to Day 180 in vitamin B6 is presented.

    Time frame: Baseline, Day 180

  22. Change From Baseline in Clinical Hematology Laboratory Tests: Erythrocytes

    Change from baseline to Day 180 in erythrocytes is presented.

    Time frame: Baseline, Day 180

  23. Change From Baseline in Clinical Hematology Laboratory Tests: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration

    Change from baseline to Day 180 in hemoglobin and erythrocytes mean corpuscular hemoglobin concentration are presented.

    Time frame: Baseline, Day 180

  24. Change From Baseline in Clinical Hematology Laboratory Tests: Hematocrit

    Change from baseline to Day 180 in hematocrit is presented.

    Time frame: Baseline, Day 180

  25. Change From Baseline in Clinical Hematology Laboratory Tests: Erythrocytes (Ery.) Mean Corpuscular Volume and Mean Platelet Volume

    Change from baseline to Day 180 in ery. mean corpuscular volume and mean platelet volume are presented.

    Time frame: Baseline, Day 180

  26. Change From Baseline in Clinical Hematology Laboratory Tests: Erythrocytes Mean Corpuscular Hemoglobin

    Change from baseline to Day 180 in erythrocytes mean corpuscular hemoglobin is presented.

    Time frame: Baseline, Day 180

  27. Change From Baseline in Clinical Hematology Laboratory Tests: Reticulocytes, Platelets, Leukocytes, Lymphocytes, Monocytes, Eosinophils, Basophils, Neutrophils

    Change from baseline to Day 180 in reticulocytes, platelets, leukocytes, lymphocytes, monocytes, eosinophils, basophils, neutrophils are presented.

    Time frame: Baseline, Day 180

  28. Change From Baseline in Clinical Hematology Laboratory Tests: Lymphocytes/Leukocytes

    Change from baseline to Day 180 in lymphocytes/leukocytes is presented.

    Time frame: Baseline, Day 180

  29. Change From Baseline in Clinical Hematology Laboratory Tests: Monocytes/Leukocytes

    Change from baseline to Day 180 in monocytes/leukocytes is presented.

    Time frame: Baseline, Day 180

  30. Change From Baseline in Clinical Hematology Laboratory Tests: Eosinophils/Leukocyte

    Change from baseline to Day 180 in eosinophils/leukocytes is presented.

    Time frame: Baseline, Day 180

  31. Change From Baseline in Clinical Hematology Laboratory Tests: Basophils/Leukocytes

    Change from baseline to Day 180 in basophils/leukocytes is presented.

    Time frame: Baseline, Day 180

  32. Change From Baseline in Clinical Hematology Laboratory Tests: Neutrophils/Leukocytes

    Change from baseline to Day 180 in neutrophils/leukocytes is presented.

    Time frame: Baseline, Day 180

  33. Change From Baseline in Clinical Urinalysis Laboratory Tests: Specific Gravity

    Change from baseline to Day 180 in urine specific gravity is presented.

    Time frame: Baseline, Day 180

  34. Change From Baseline in Clinical Urinalysis Laboratory Tests: pH

    Change from baseline to Day 180 in urine pH is presented.

    Time frame: Baseline, Day 180

  35. Maximum Observed Plasma Concentration (Cmax) of DCR-PHXC

    The Cmax was defined as the maximum observed plasma concentration during a dosing interval. Data for this endpoint is reported only for adults and adolescent participants from PK population.

    Time frame: For adults: Day 1 and 30: predose, 5, 15, and 30 minutes and 1, 2, 4, 6, 10, and 12 hours (hrs) postdose; Day 150: predose, 2, 6, and 12 hours postdose For adolescents: Days 1 and 30: predose, 30 minutes and 2 and 10 hours postdose

  36. Area Under the Curve From Time of Administration to the Last Measurable Concentration (AUC0-last) of of DCR-PHXC

    AUC0-last was defined as the area under the curve from time of administration to the last measurable concentration. Data for this endpoint is reported only for adults and adolescent participants from PK population.

    Time frame: For adults: Day 1 and 30: predose, 5, 15, and 30 minutes and 1, 2, 4, 6, 10, and 12 hours postdose; Day 150: predose, 2, 6, and 12 hours postdose For adolescents: Days 1 and 30: predose, 30 minutes and 2 and 10 hours postdose

07

Results

Posted May 22, 2024

Participant flow

The study was conducted at 19 sites in France, Spain, Italy, Netherlands, Germany, United Kingdom, Australia, United States, Canada, Lebanon, and Japan.

Participant flow — Overall Study
MilestoneDCR-PHXCPlacebo
Started2312
Safety population2312
Intent to treat (itt) population2312
Modified itt (mitt) population2212
Completed2211
Not completed11
Withdrew: Withdrawal by subject11

Outcome measures

PrimaryAUC From Day 90 To Day 180, Based on Percent Change From Baseline in 24-Hour Uox

The AUC of 24-hour urinary oxalate (Uox) from Day 90 to Day 180, based on percent change from baseline, was compared between the active treatment group and placebo group. A multiple imputation approach was used to handle missing Uox data and then calculate the AUC.

Time frame:
From Day 90 to 180
Reported as:
Least squares mean · Percent change in 24-hour Uox AUC
AUC From Day 90 To Day 180, Based on Percent Change From Baseline in 24-Hour Uox
Percent change in 24-hour Uox AUCDCR-PHXCPlacebo
AUC From Day 90 To Day 180, Based on Percent Change From Baseline in 24-Hour Uox3507.4 ± 788.49-1664.4 ± 1189.96
Statistical analysis
  • DCR-PHXC vs Placebo · ANCOVA · p = <0.0001 · Difference of least mean square: 5171.7 · 95% CI 2929.3 to 7414.2
SecondaryPercentage of Participants Whose 24-hour Uox Values Normalized or Near-normalized on at Least 2 Consecutive Visits

Percentage of participants whose 24-hour Uox values normalized or near-normalized on at least 2 consecutive visits are presented. Normalization of Uox was defined as less than (\<) 0.46 millimole per 24 hours (mmol/24 hours) and near normalization was defined as greater than or equal to (\>=) 0.46 to \< 0.60 mmol/24 hours (values adjusted per 1.73 square meter \[1.73 m\^2\] body surface area \[BSA\] in participants aged \<18 years).

Time frame:
From Day 90 to 180
Reported as:
Number · Percentage of participants
Percentage of Participants Whose 24-hour Uox Values Normalized or Near-normalized on at Least 2 Consecutive Visits
Percentage of participantsDCR-PHXCPlacebo
Percentage of Participants Whose 24-hour Uox Values Normalized or Near-normalized on at Least 2 Consecutive Visits500
SecondaryPercent Change From Baseline to Day 180 in the Summed Surface Area of Kidney Stones

Percent change from baseline to Day 180 in the summed surface area measured in millimetre square (mm\^2) of kidney stones is presented.

Time frame:
Baseline, Day 180
Reported as:
Median · Percent change in summed surface area
Percent Change From Baseline to Day 180 in the Summed Surface Area of Kidney Stones
Percent change in summed surface areaDCR-PHXCPlacebo
Percent Change From Baseline to Day 180 in the Summed Surface Area of Kidney Stones-2.13 (-100.0 to 228.6)21.77 (-24.3 to 1500.0)
SecondaryPercent Change From Baseline to Day 180 in the Number of Kidney Stones

Percent change from baseline to Day 180 in the number of kidney stones is presented.

Time frame:
Baseline, Day 180
Reported as:
Median · Percent change in kidney stone numbers
Percent Change From Baseline to Day 180 in the Number of Kidney Stones
Percent change in kidney stone numbersDCR-PHXCPlacebo
Percent Change From Baseline to Day 180 in the Number of Kidney Stones0.00 (-100.0 to 200.0)0.00 (-94.1 to 100.0)
SecondaryPercent Change From Baseline to Day 180 in Plasma Oxalate (For Adults Only)

Percent change from baseline to Day 180 in plasma oxalate (for adults only) is presented.

Time frame:
Baseline, Day 180
Reported as:
Median · Percent change in plasma oxalate
Percent Change From Baseline to Day 180 in Plasma Oxalate (For Adults Only)
Percent change in plasma oxalateDCR-PHXCPlacebo
Percent Change From Baseline to Day 180 in Plasma Oxalate (For Adults Only)-25.00 (-61.9 to 22.2)-0.00 (-25.0 to 350.0)
SecondaryRate of Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Day 180

Monthly rate of eGFR change is presented. eGFR was calculated using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and creatinine-based equation.

Time frame:
Baseline, Day 180
Reported as:
Mean · mL/minute/1.73 m^2
Rate of Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Day 180
mL/minute/1.73 m^2DCR-PHXCPlacebo
Rate of Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Day 1800.3533 ± 0.396101.1008 ± 0.54849
SecondaryNumber of Treatment Emergent Adverse Events (TEAEs) And Serious Treatment Emergent Adverse Events (TEAEs)

Number of TEAEs and TESAEs are presented. An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalisation, results in persistent disability/incapacity or is a congenital anomaly/birth defect. TEAE was defined as any AE with an onset date/time on or after administration (including any partial administration) of the first dose of study intervention and through the study completion date from the end of study case report form (CRF).

Time frame:
From Baseline up to Day 180
Reported as:
Number · Events
Number of Treatment Emergent Adverse Events (TEAEs) And Serious Treatment Emergent Adverse Events (TEAEs)
EventsDCR-PHXCPlacebo
TEAEs10154
Serious TEAEs13
SecondaryChange From Baseline in Electrocardiogram (ECG): Heart Rate

Change from baseline in heart rate is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · beats per minute (beats/min)
Change From Baseline in Electrocardiogram (ECG): Heart Rate
beats per minute (beats/min)DCR-PHXCPlacebo
Change From Baseline in Electrocardiogram (ECG): Heart Rate0.4 ± 8.36-1.8 ± 9.18
SecondaryChange From Baseline in ECG: PR Interval, QRS Duration, QT Interval, QTcB Interval, QTcF Interval and RR Interval

Change from baseline in PR interval, QRS duration, QT interval, QTcB interval, QTcF interval and RR interval is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · milliseconds (msec)
Change From Baseline in ECG: PR Interval, QRS Duration, QT Interval, QTcB Interval, QTcF Interval and RR Interval
milliseconds (msec)DCR-PHXCPlacebo
PR interval-0.5 ± 13.921.3 ± 8.14
QRS duration1.3 ± 6.01-1.5 ± 7.53
QT interval-2.4 ± 23.734.0 ± 22.97
QTcB interval-0.8 ± 15.60-0.7 ± 17.31
QTcF interval-1.1 ± 15.801.2 ± 15.59
RR interval-7.6 ± 99.3517.8 ± 109.73
SecondaryNumber of Participants With Most Abnormal Post-Baseline Shift in Physical Examination

Number of participants who had most abnormal post-baseline shift in physical examination are presented. Physical examination shifts were categories into 4 categories: 1) missing; 2) normal; 3) abnormal-not clinically significant (NCS) and 4) abnormal-clinically significant (CS). Each category was presented according body systems including: 1) eyes, ears, nose and throat; 2) chest/respiratory; 3) heart/cardiovascular; 4) gastrointestinal/liver; 5) musculoskeletal/extremities; 6) dermatological/skin; 7) thyroid/neck; 8) lymph nodes; 9) neurological.

Time frame:
Baseline up to Day 180
Reported as:
Count of participants · Participants
Number of Participants With Most Abnormal Post-Baseline Shift in Physical Examination
ParticipantsDCR-PHXCPlacebo
Eyes, ears, nose and throat — missing11
Eyes, ears, nose and throat — normal2111
Eyes, ears, nose and throat — abnormal-NCS10
Eyes, ears, nose and throat — abnormal-CS00
Chest/respiratory — missing00
Chest/respiratory — normal2312
Chest/respiratory — abnormal-NCS00
Chest/respiratory — abnormal-CS00
Heart/cardiovascular — missing00
Heart/cardiovascular — normal2212
Heart/cardiovascular — abnormal-NCS10
Heart/cardiovascular — abnormal-CS00
Gastrointestinal/liver — missing00
Gastrointestinal/liver — normal228
Gastrointestinal/liver — abnormal-NCS14
Gastrointestinal/liver — abnormal-CS00
Musculoskeletal/extremities — missing11
Musculoskeletal/extremities — normal2210
Musculoskeletal/extremities — abnormal-NCS01
Musculoskeletal/extremities — abnormal-CS00
Dermatological/skin — missing00
Dermatological/skin — normal188
Dermatological/skin — abnormal-NCS44
Dermatological/skin — abnormal-CS10
Thyroid/neck — missing11
Thyroid/neck — normal2210
Thyroid/neck — abnormal-NCS01
Thyroid/neck — abnormal-CS00
Lymph nodes — missing01
Lymph nodes — normal2310
Lymph nodes — abnormal-NCS01
Lymph nodes — abnormal-CS00
SecondaryChange From Baseline in Vital Signs: Height

Change from baseline to Day 180 in height is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · centimetres (cm)
Change From Baseline in Vital Signs: Height
centimetres (cm)DCR-PHXCPlacebo
Change From Baseline in Vital Signs: Height0.70 ± 2.3831.08 ± 1.446
SecondaryChange From Baseline in Vital Signs: Weight

Change from baseline to Day 180 in weight is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · kilograms
Change From Baseline in Vital Signs: Weight
kilogramsDCR-PHXCPlacebo
Change From Baseline in Vital Signs: Weight1.134 ± 3.47941.350 ± 3.4330
SecondaryChange From Baseline in Vital Signs: Body Mass Index (BMI)

Change from baseline to Day 180 in BMI is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · Kilograms per square meter (kg/m^2)
Change From Baseline in Vital Signs: Body Mass Index (BMI)
Kilograms per square meter (kg/m^2)DCR-PHXCPlacebo
Change From Baseline in Vital Signs: Body Mass Index (BMI)0.23 ± 1.1750.14 ± 1.293
SecondaryChange From Baseline in Vital Signs: Oral Body Temperature

Change from baseline to Day 180 in oral body temperature is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · Degree Celsius (C)
Change From Baseline in Vital Signs: Oral Body Temperature
Degree Celsius (C)DCR-PHXCPlacebo
Change From Baseline in Vital Signs: Oral Body Temperature0.01 ± 0.3990.05 ± 0.446
SecondaryChange From Baseline in Vital Signs: Heart Rate

Change from baseline to Day 180 in heart rate is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · beats/minute
Change From Baseline in Vital Signs: Heart Rate
beats/minuteDCR-PHXCPlacebo
Change From Baseline in Vital Signs: Heart Rate0.8 ± 10.64-3.1 ± 6.35
SecondaryChange From Baseline in Vital Signs: Respiratory Rate

Change from baseline to Day 180 in respiratory rate is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · Breaths per minute
Change From Baseline in Vital Signs: Respiratory Rate
Breaths per minuteDCR-PHXCPlacebo
Change From Baseline in Vital Signs: Respiratory Rate-0.2 ± 3.02-1.1 ± 5.00
SecondaryChange From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure

Change from baseline to Day 180 in systolic and diastolic blood pressure is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · millimetres of mercury (mmHg)
Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure
millimetres of mercury (mmHg)DCR-PHXCPlacebo
Systolic blood pressure-2.0 ± 13.64-3.0 ± 9.82
Diastolic blood pressure0.8 ± 9.20-2.6 ± 11.84
SecondaryChange From Baseline in Clinical Chemistry Laboratory Tests: Alanine Aminotransferase, Aspartate Aminotransferase, Glutamate Dehydrogenase, Gamma Glutamyl Transferase, Alkaline Phosphatase, Lactate Dehydrogenase and Creatine Kinase

Change from baseline to Day 180 in alanine aminotransferase, aspartate aminotransferase, glutamate dehydrogenase, gamma glutamyl transferase, alkaline phosphatase, lactate dehydrogenase and creatine kinase are presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · Units per litre (U/L)
Change From Baseline in Clinical Chemistry Laboratory Tests: Alanine Aminotransferase, Aspartate Aminotransferase, Glutamate Dehydrogenase, Gamma Glutamyl Transferase, Alkaline Phosphatase, Lactate Dehydrogenase and Creatine Kinase
Units per litre (U/L)DCR-PHXCPlacebo
Alanine aminotransferase1.0 ± 8.59-1.1 ± 4.59
Aspartate aminotransferase-0.2 ± 4.95-1.3 ± 4.73
Glutamate dehydrogenase-0.15 ± 1.913-0.38 ± 1.064
Gamma glutamyl transferase2.7 ± 4.12-0.2 ± 3.03
Alkaline phosphatase3.0 ± 29.11-16.8 ± 41.78
Lactate dehydrogenase4.1 ± 20.511.0 ± 20.72
Creatine kinase7.5 ± 59.28-34.1 ± 160.46
SecondaryChange From Baseline in Clinical Chemistry Laboratory Tests: Bilirubin, Direct Bilirubin and Creatinine

Change from baseline to Day 180 in bilirubin, direct bilirubin and creatinine are presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · micromoles per litre (umol/L)
Change From Baseline in Clinical Chemistry Laboratory Tests: Bilirubin, Direct Bilirubin and Creatinine
micromoles per litre (umol/L)DCR-PHXCPlacebo
Bilirubin1.0 ± 3.180.4 ± 1.80
Direct bilirubin0.1 ± 1.320.1 ± 0.32
Creatinine-1.2 ± 10.814.3 ± 11.02
SecondaryChange From Baseline in Clinical Chemistry Laboratory Tests: Protein, Albumin

Change from baseline to Day 180 in protein and albumin are presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · grams per litre (g/L)
Change From Baseline in Clinical Chemistry Laboratory Tests: Protein, Albumin
grams per litre (g/L)DCR-PHXCPlacebo
Protein0.4 ± 4.471.5 ± 6.27
Albumin0.5 ± 3.221.2 ± 3.63
SecondaryChange From Baseline in Clinical Chemistry Laboratory Tests: Sodium, Chloride, Potassium and Urea

Change from baseline to Day 180 in sodium, chloride, potassium and urea are presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · millimoles per litre (mmol/L)
Change From Baseline in Clinical Chemistry Laboratory Tests: Sodium, Chloride, Potassium and Urea
millimoles per litre (mmol/L)DCR-PHXCPlacebo
Sodium0.4 ± 2.440.2 ± 3.03
Chloride0.6 ± 3.30-0.4 ± 4.08
Potassium-0.04 ± 0.4250.05 ± 0.360
Urea0.01 ± 0.8950.40 ± 1.197
SecondaryChange From Baseline in Clinical Chemistry Laboratory Tests: Vitamin B6

Change from baseline to Day 180 in vitamin B6 is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · nanomoles per litre (nmol/L)
Change From Baseline in Clinical Chemistry Laboratory Tests: Vitamin B6
nanomoles per litre (nmol/L)DCR-PHXCPlacebo
Change From Baseline in Clinical Chemistry Laboratory Tests: Vitamin B634.60 ± 99.278-215.73 ± 337.775
SecondaryChange From Baseline in Clinical Hematology Laboratory Tests: Erythrocytes

Change from baseline to Day 180 in erythrocytes is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · 10^12 cells per liter
Change From Baseline in Clinical Hematology Laboratory Tests: Erythrocytes
10^12 cells per literDCR-PHXCPlacebo
Change From Baseline in Clinical Hematology Laboratory Tests: Erythrocytes-0.04 ± 0.3650.02 ± 0.230
SecondaryChange From Baseline in Clinical Hematology Laboratory Tests: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration

Change from baseline to Day 180 in hemoglobin and erythrocytes mean corpuscular hemoglobin concentration are presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · gram per litre (g/L)
Change From Baseline in Clinical Hematology Laboratory Tests: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration
gram per litre (g/L)DCR-PHXCPlacebo
Hemoglobin-1.7 ± 8.900.1 ± 6.62
Ery. mean corpuscular hemoglobin concentration1.5 ± 15.10-4.8 ± 10.80
SecondaryChange From Baseline in Clinical Hematology Laboratory Tests: Hematocrit

Change from baseline to Day 180 in hematocrit is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · Litre/litre (L/L)
Change From Baseline in Clinical Hematology Laboratory Tests: Hematocrit
Litre/litre (L/L)DCR-PHXCPlacebo
Change From Baseline in Clinical Hematology Laboratory Tests: Hematocrit-0.004 ± 0.02710.006 ± 0.0288
SecondaryChange From Baseline in Clinical Hematology Laboratory Tests: Erythrocytes (Ery.) Mean Corpuscular Volume and Mean Platelet Volume

Change from baseline to Day 180 in ery. mean corpuscular volume and mean platelet volume are presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · femtoliter (fL)
Change From Baseline in Clinical Hematology Laboratory Tests: Erythrocytes (Ery.) Mean Corpuscular Volume and Mean Platelet Volume
femtoliter (fL)DCR-PHXCPlacebo
Ery. mean corpuscular volume0.0 ± 2.311.1 ± 3.57
Mean platelet volume-0.03 ± 0.8640.61 ± 0.547
SecondaryChange From Baseline in Clinical Hematology Laboratory Tests: Erythrocytes Mean Corpuscular Hemoglobin

Change from baseline to Day 180 in erythrocytes mean corpuscular hemoglobin is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · picogram (pg)
Change From Baseline in Clinical Hematology Laboratory Tests: Erythrocytes Mean Corpuscular Hemoglobin
picogram (pg)DCR-PHXCPlacebo
Change From Baseline in Clinical Hematology Laboratory Tests: Erythrocytes Mean Corpuscular Hemoglobin-0.1 ± 1.37-0.1 ± 0.99
SecondaryChange From Baseline in Clinical Hematology Laboratory Tests: Reticulocytes, Platelets, Leukocytes, Lymphocytes, Monocytes, Eosinophils, Basophils, Neutrophils

Change from baseline to Day 180 in reticulocytes, platelets, leukocytes, lymphocytes, monocytes, eosinophils, basophils, neutrophils are presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · 10^12 cells per liter
Change From Baseline in Clinical Hematology Laboratory Tests: Reticulocytes, Platelets, Leukocytes, Lymphocytes, Monocytes, Eosinophils, Basophils, Neutrophils
10^12 cells per literDCR-PHXCPlacebo
Reticulocytes0.2 ± 30.08-23.1 ± 32.21
Platelets-11.4 ± 54.502.3 ± 53.30
Leukocytes0.18 ± 1.573-1.03 ± 1.931
Lymphocytes-0.03 ± 0.6210.06 ± 0.331
Monocytes0.07 ± 0.085-0.02 ± 0.103
Eosinophils0.03 ± 0.0720.04 ± 0.126
Basophils0.01 ± 0.062-0.04 ± 0.097
Neutrophils0.14 ± 1.195-1.07 ± 1.700
SecondaryChange From Baseline in Clinical Hematology Laboratory Tests: Lymphocytes/Leukocytes

Change from baseline to Day 180 in lymphocytes/leukocytes is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · Percentage of lymphocytes/leukocytes
Change From Baseline in Clinical Hematology Laboratory Tests: Lymphocytes/Leukocytes
Percentage of lymphocytes/leukocytesDCR-PHXCPlacebo
Change From Baseline in Clinical Hematology Laboratory Tests: Lymphocytes/Leukocytes-1.3 ± 10.265.1 ± 10.21
SecondaryChange From Baseline in Clinical Hematology Laboratory Tests: Monocytes/Leukocytes

Change from baseline to Day 180 in monocytes/leukocytes is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · Percentage of monocytes/leukocytes
Change From Baseline in Clinical Hematology Laboratory Tests: Monocytes/Leukocytes
Percentage of monocytes/leukocytesDCR-PHXCPlacebo
Change From Baseline in Clinical Hematology Laboratory Tests: Monocytes/Leukocytes1.0 ± 2.040.9 ± 2.51
SecondaryChange From Baseline in Clinical Hematology Laboratory Tests: Eosinophils/Leukocyte

Change from baseline to Day 180 in eosinophils/leukocytes is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · Percentage of eosinophils/leukocytes
Change From Baseline in Clinical Hematology Laboratory Tests: Eosinophils/Leukocyte
Percentage of eosinophils/leukocytesDCR-PHXCPlacebo
Change From Baseline in Clinical Hematology Laboratory Tests: Eosinophils/Leukocyte0.4 ± 1.560.9 ± 1.66
SecondaryChange From Baseline in Clinical Hematology Laboratory Tests: Basophils/Leukocytes

Change from baseline to Day 180 in basophils/leukocytes is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · Percentage of basophils/leukocytes
Change From Baseline in Clinical Hematology Laboratory Tests: Basophils/Leukocytes
Percentage of basophils/leukocytesDCR-PHXCPlacebo
Change From Baseline in Clinical Hematology Laboratory Tests: Basophils/Leukocytes0.0 ± 0.770.1 ± 0.74
SecondaryChange From Baseline in Clinical Hematology Laboratory Tests: Neutrophils/Leukocytes

Change from baseline to Day 180 in neutrophils/leukocytes is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · Percentage of neutrophils/leukocytes
Change From Baseline in Clinical Hematology Laboratory Tests: Neutrophils/Leukocytes
Percentage of neutrophils/leukocytesDCR-PHXCPlacebo
Change From Baseline in Clinical Hematology Laboratory Tests: Neutrophils/Leukocytes-0.3 ± 11.45-7.1 ± 13.14
SecondaryChange From Baseline in Clinical Urinalysis Laboratory Tests: Specific Gravity

Change from baseline to Day 180 in urine specific gravity is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · gram per millilitre (g/mL)
Change From Baseline in Clinical Urinalysis Laboratory Tests: Specific Gravity
gram per millilitre (g/mL)DCR-PHXCPlacebo
Change From Baseline in Clinical Urinalysis Laboratory Tests: Specific Gravity0.0000 ± 0.00872-0.0008 ± 0.00480
SecondaryChange From Baseline in Clinical Urinalysis Laboratory Tests: pH

Change from baseline to Day 180 in urine pH is presented.

Time frame:
Baseline, Day 180
Reported as:
Mean · pH
Change From Baseline in Clinical Urinalysis Laboratory Tests: pH
pHDCR-PHXCPlacebo
Change From Baseline in Clinical Urinalysis Laboratory Tests: pH0.29 ± 1.067-0.10 ± 0.738
SecondaryMaximum Observed Plasma Concentration (Cmax) of DCR-PHXC

The Cmax was defined as the maximum observed plasma concentration during a dosing interval. Data for this endpoint is reported only for adults and adolescent participants from PK population.

Time frame:
For adults: Day 1 and 30: predose, 5, 15, and 30 minutes and 1, 2, 4, 6, 10, and 12 hours (hrs) postdose; Day 150: predose, 2, 6, and 12 hours postdose For adolescents: Days 1 and 30: predose, 30 minutes and 2 and 10 hours postdose
Reported as:
Geometric mean · nanogram per millilitre (ng/mL)
Maximum Observed Plasma Concentration (Cmax) of DCR-PHXC
nanogram per millilitre (ng/mL)DCR-PHXC: AdultsDCR-PHXC: Adolescents
Day 1778 ± 35.7363 ± 76.7
Day 30774 ± 46.1350 ± 48.6
Day 150648 ± 55.5—
SecondaryArea Under the Curve From Time of Administration to the Last Measurable Concentration (AUC0-last) of of DCR-PHXC

AUC0-last was defined as the area under the curve from time of administration to the last measurable concentration. Data for this endpoint is reported only for adults and adolescent participants from PK population.

Time frame:
For adults: Day 1 and 30: predose, 5, 15, and 30 minutes and 1, 2, 4, 6, 10, and 12 hours postdose; Day 150: predose, 2, 6, and 12 hours postdose For adolescents: Days 1 and 30: predose, 30 minutes and 2 and 10 hours postdose
Reported as:
Geometric mean · hours*nanograms per millilitre (h*ng/mL)
Area Under the Curve From Time of Administration to the Last Measurable Concentration (AUC0-last) of of DCR-PHXC
hours*nanograms per millilitre (h*ng/mL)DCR-PHXC: AdultsDCR-PHXC: Adolescents
Day 112500 ± 29.36450 ± 54.5
Day 3012800 ± 38.46400 ± 45.1
Day 1506100 ± 46.2—

Adverse events

Collected over From Day 1 up to end of the study (Day 180). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
DCR-PHXC0/23 (0%)1/23 (4.3%)16/23 (69.6%)
Placebo0/12 (0%)2/12 (16.7%)10/12 (83.3%)
Most frequent serious events
Most frequent serious events
EventDCR-PHXCPlacebo
Blood creatinine increasedBlood and lymphatic system disorders0/231/12
NephrolithiasisRenal and urinary disorders0/231/12
Renal colicRenal and urinary disorders0/231/12
TachycardiaCardiac disorders1/230/12
Most frequent other events
Showing 10 of 42
Most frequent other events
EventDCR-PHXCPlacebo
HeadacheNervous system disorders4/233/12
Injection site erythemaGeneral disorders5/230/12
NauseaGastrointestinal disorders4/231/12
FatigueGeneral disorders1/232/12
Abdominal pain upperGastrointestinal disorders0/232/12
NephrolithiasisRenal and urinary disorders2/232/12
Back painMusculoskeletal and connective tissue disorders0/232/12
Injection site painGeneral disorders2/230/12
DysmenorrhoeaReproductive system and breast disorders2/230/12
Oropharyngeal painRespiratory, thoracic and mediastinal disorders2/230/12

Baseline characteristics

Age, Continuous
Age, Continuous(years)DCR-PHXCPlaceboTotal
Mean23.7 ± 11.9523.6 ± 11.4823.7 ± 11.62
Age, Customized
Age, Customized(Participants)DCR-PHXCPlaceboTotal
Between 2 to 11 years325
Between 12 to 17 years6410
Between 18 to 64 years14620
Sex: Female, Male
Sex: Female, Male(Participants)DCR-PHXCPlaceboTotal
Female12618
Male11617
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)DCR-PHXCPlaceboTotal
Hispanic or Latino202
Not Hispanic or Latino191130
Unknown or Not Reported213
Race (NIH/OMB)
Race (NIH/OMB)(Participants)DCR-PHXCPlaceboTotal
American Indian or Alaska Native000
Asian606
Native Hawaiian or Other Pacific Islander000
Black or African American000
White151025
More than one race011
Unknown or Not Reported213
08

Study locations

28 sites
  • Clinical Trial Site
    San Francisco, California 94143, United States
  • Clinical Trial Site
    Boston, Massachusetts 02115, United States
  • Clinical Trial Site
    Rochester, Minnesota 55905, United States
  • Clinical Trial Site
    New York, New York 10016, United States
  • Clinical Trial Site
    Pittsburgh, Pennsylvania 15224, United States
  • Clinical Trial Site
    Herston, 4029, Australia
  • Clinical Trial Site
    Parkville, 3052, Australia
  • Clinical Trial Site
    Hamilton, Canada
  • Clinical Trial Site
    Bron, France
  • Clinical Trial Site
    Paris, 75019, France
  • Clinical Trial Site
    Bonn, 53127, Germany
  • Clinical Trial Site
    Heidelberg, 69120, Germany
  • Clinical Trial Site
    Jerusalem, 9103102, Israel
  • Clinical Trial Site
    Roma, 00165, Italy
  • Clinical Trial Site
    Nagoya, 467-8601, Japan
  • Clinical Trial Site
    Tochigi, 329-0431, Japan
  • Clinical Trial Site
    Tokyo, 183-8561, Japan
  • Clinical Trial Site
    Beirut, 2807, Lebanon
  • Clinical Trial Site
    Beirut, Lebanon
  • Clinical Trial Site
    Amsterdam, 1105 AZ, Netherlands
  • Clinical Trial Site
    Auckland, New Zealand
  • Clinical Trial Site
    Bialystok, Poland
  • Clinical Trial Site
    Bucharest, Romania
  • Clinical Trial Site
    Barcelona, 08035, Spain
  • Clinical Trial Site
    Santa Cruz, 38320, Spain
  • Clinical Trial Site
    Birmingham, United Kingdom
  • Clinical Trial Site
    London, WCIN 3JH, United Kingdom
  • Clinical Trial Site
    London, United Kingdom
09

References and documents

Publications

  • Zhang S, Gamallo P, Rawson V. Population Pharmacokinetic and Pharmacodynamic Modelling and Simulation for Nedosiran Clinical Development and Dose Guidance in Pediatric Patients with Primary Hyperoxaluria Type 1. Clin Pharmacokinet. 2025 Sep;64(9):1395-1411. doi: 10.1007/s40262-025-01540-1. Epub 2025 Jul 2. PubMed 40601241 ↗
  • Cox JH, Boily MO, Caron A, Sheng T, Wu J, Ding J, Gaudreault S, Chong O, Surendradoss J, Gomez R, Lester J, Dumais V, Li X, Gumpena R, Hall MD, Waterson AG, Stott G, Flint AJ, Moore WJ, Lowther WT, Knight J, Percival MD, Tong V, Oballa R, Powell DA, King AJ. Characterization of CHK-336, A First-in-Class, Liver-Targeted, Small-Molecule Lactate Dehydrogenase Inhibitor for Hyperoxaluria Treatment. J Am Soc Nephrol. 2025 Apr 7;36(8):1535-1547. doi: 10.1681/ASN.0000000690. PubMed 40193200 ↗
  • Baum MA, Langman C, Cochat P, Lieske JC, Moochhala SH, Hamamoto S, Satoh H, Mourani C, Ariceta G, Torres A, Wolley M, Belostotsky V, Forbes TA, Groothoff J, Hayes W, Tonshoff B, Takayama T, Rosskamp R, Russell K, Zhou J, Amrite A, Hoppe B; PHYOX2 study investigators. PHYOX2: a pivotal randomized study of nedosiran in primary hyperoxaluria type 1 or 2. Kidney Int. 2023 Jan;103(1):207-217. doi: 10.1016/j.kint.2022.07.025. Epub 2022 Aug 22. PubMed 36007597 ↗

Study documents

  • Study protocol · Aug 13, 2020
  • Statistical analysis plan · Jul 16, 2021

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

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2019 to primary completion in Jun 2021, 19 months.

Results were first posted in May 2024, 2 years 11 months after primary completion. A results delay was requested in Jun 2022.

Of 110 industry-sponsored phase 2 interventional studies under Kidney Diseases, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's 19 months is close to that.

Counting every sponsor, half of 183 studies reached it within 22 months; a quarter within 14 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2019
First posted
Feb 20, 2019
StartActual
Oct 28, 2019
Primary completionActual
Jun 21, 2021
CompletionActual
Jun 29, 2021
Results delay requested
Jun 20, 2022
Results first posted
May 22, 2024
Last update
May 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03847909
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Feb 20, 2019
Start date
Oct 28, 2019
Primary completion
Jun 21, 2021
Completion
Jun 29, 2021
Results posted
May 22, 2024
Last update
May 22, 2024

Study contacts

Clinical Transparency (dept. 1452)
study director · Novo Nordisk A/S

Oversight

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

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