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NCT03523728 · ClinicalTrials.gov registry record · Phase 2
A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD Patients
A Phase 2 study, sponsored by Genzyme, a Sanofi Company.
- Terminated
- Registry status
- Phase 2
- Development phase
- 478
- Enrollment target
NCT03523728: Clinical Trial Phase 2 study, sponsored by Genzyme, a Sanofi Company.
NCT03523728 is a Phase 2 study that was terminated before completion, run by Genzyme, a Sanofi Company. The registered enrollment target is 478 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (259% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03523728, a Phase 2 study, was terminated before completion, sponsored by Genzyme, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 478 participants
- Enrollment target
Study Summary
Primary Objective: To determine the effect of venglustat on the rate of total kidney volume (TKV) growth (Stage 1) and estimated glomerular filtration rate (eGFR) decline in participants at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) (Stage 2). Secondary Objectives: * To determine the effect of venglustat on the rate of renal function decline (Stage 1) and on the rate of TKV growth (Stage 2). * To evaluate the pharmacokinetics (PK) of venglustat in ADPKD participants (Stages 1 and 2). * To determine the effect of venglustat on pain and fatigue, based on participant reported diary (Stages 1 and 2). * Safety/tolerability objectives: * To characterize the safety profile of venglustat (Stages 1 and 2). * To evaluate the effect of venglustat on mood using Beck Depression Inventory II (BDI-II) (Stages 1 and 2). * To evaluate the effect of venglustat on the lens by ophthalmological examination (Stages 1 and 2).
Primary Outcome
Total kidney volume is a measure for assessing disease progression in participants with ADPKD, a prognostic biomarker of renal function decline and progression to end-stage renal disease. Kidney volume was assessed using magnetic resonance imaging (MRI). The annualized slope of change in TKV (in percentage \[%\] per year) in each treatment group was obtained from the back-transformation of the mean slope of log10-transformed TKV obtained from the linear mixed effect model. The model included fix
Interventions
- DRUG Placebo
- DRUG Venglustat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 478 participants |
| Start Date | 2018-10-04 |
| Est. Completion | 2021-08-03 |
| Phase | Phase 2 |
Why NCT03523728 stopped before completion
NCT03523728 is an interventional study that assigns participants to a tested intervention. The registered 478 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (259% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03523728 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03523728 about?
NCT03523728 is a clinical study titled "A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD Patients". Primary Objective: To determine the effect of venglustat on the rate of total kidney volume (TKV) growth (Stage 1) and estimated glomerular filtration rate (eGFR) decline in participants at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) (Stage 2). Secondary Object...
What is the current status of trial NCT03523728?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 478 participants. The study started on 2018-10-04. Estimated completion is 2021-08-03.
What interventions are being tested in trial NCT03523728?
The interventions under investigation include: Placebo (DRUG), Venglustat (DRUG).
Who is sponsoring clinical trial NCT03523728?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03523728's enrollment target sits among peer trials
478 77th of 2000 higher than 1,924 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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