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NCT04705051 · ClinicalTrials.gov registry record · Phase 3
Long-term Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) With Venglustat
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
NCT04705051: Clinical Trial Phase 3 study, sponsored by Sanofi.
NCT04705051 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 24 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04705051, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
Study Summary
Primary Objective: -To determine the effect of early versus delayed treatment with venglustat on the total kidney volume (TKV) in participants at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD). Secondary Objective: * To determine the effect of early versus delayed treatment with venglustat on the renal function (estimated glomerular filtration rate \[eGFR\] \[Chronic Kidney Disease Epidemiology Collaboration {CKD-EPI} equation\]). * To characterize the safety profile of venglustat. * To evaluate the effect of venglustat on the lens by ophthalmological examination. * To evaluate the effect of venglustat on mood using Beck Depression Inventory-II (BDI-II).
Primary Outcome
Total kidney volume is a measure of disease progression in the ADPKD participants. Study LTS15823 was terminated prematurely by the Sponsor following a decision to terminate the parent study EFC15392 (NCT03523728). Study EFC15392 was terminated based on the results of the planned prespecified futility analysis performed for this study. Termination decision was due to a lack of efficacy in the ADPKD population and not linked to safety findings with venglustat. Due to the early termination of stud
Interventions
- DRUG Venglustat GZ402671
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-02-09 |
| Est. Completion | 2021-07-13 |
| Phase | Phase 3 |
Why NCT04705051 stopped before completion
NCT04705051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Venglustat GZ402671 is the first listed.
NCT04705051 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04705051 about?
NCT04705051 is a clinical study titled "Long-term Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) With Venglustat". Primary Objective: -To determine the effect of early versus delayed treatment with venglustat on the total kidney volume (TKV) in participants at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD). Secondary Objective: * To determine the effect of early versus delaye...
What is the current status of trial NCT04705051?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2021-02-09. Estimated completion is 2021-07-13.
What interventions are being tested in trial NCT04705051?
The interventions under investigation include: Venglustat GZ402671 (DRUG).
Who is sponsoring clinical trial NCT04705051?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04705051's enrollment target sits among peer trials
24 1943rd of 2000 higher than 49 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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