MedTrace Logo

Long-term Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) With Venglustat

NCT04705051 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-17

Study results available
· View outcomes & findings →

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).

Conditions

  • Congenital Cystic Kidney Disease

Interventions

DRUG

Venglustat GZ402671

Pharmaceutical form: capsule Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-09
Primary Completion
2021-07-13
Completion
2021-07-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Germany
  • Japan
  • Netherlands
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04705051 on ClinicalTrials.gov