A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD Patients
Public ClinicalTrials.gov record NCT03523728. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03523728
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 478 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 3, 2018
- Primary completion
- Aug 2, 2021
- Completion
- Aug 2, 2021
- Last update posted
- Feb 2, 2023
2018 – 2021
United States locations
- U.S. sites
- 18
- U.S. states
- 16
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8400002 | Birmingham | Alabama | 35294 | — |
| Investigational Site Number 8400017 | Los Angeles | California | 90024 | — |
| Investigational Site Number 8400001 | San Francisco | California | 94143 | — |
| Investigational Site Number 8400008 | Aurora | Colorado | 80045 | — |
| Investigational Site Number 8400010 | New Haven | Connecticut | 06510 | — |
| Investigational Site Number 8400004 | Atlanta | Georgia | 30322 | — |
| Investigational Site Number 8400007 | Chicago | Illinois | 60637 | — |
| Investigational Site Number 8400014 | Iowa City | Iowa | 52242 | — |
| Investigational Site Number 8400003 | Kansas City | Kansas | 66103 | — |
| Investigational Site Number 8400021 | Baltimore | Maryland | 21201 | — |
| Investigational Site Number 8400016 | Boston | Massachusetts | 02111 | — |
| Investigational Site Number 8400020 | Rochester | Minnesota | 55905 | — |
| Investigational Site Number 8400027 | Kansas City | Missouri | 64111 | — |
| Investigational Site Number 8400011 | Philadelphia | Pennsylvania | 19104 | — |
| Investigational Site Number 8400015 | San Antonio | Texas | 78215 | — |
| Investigational Site Number 8400019 | Morgantown | West Virginia | 26506 | — |
| Investigational Site Number 8400005 | Madison | Wisconsin | 53792 | — |
| Investigational Site Number 8400006 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 77 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03523728, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 2, 2023 · Synced Sep 7, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03523728 live on ClinicalTrials.gov.