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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 is a Phase 2 study that was terminated before completion, run by Genzyme, a Sanofi Company. The registered enrollment target is 478 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03523728
The ClinicalTrials.gov registry entry for NCT03523728 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 478 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03523728 reports 0 study locations.
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.
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