A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD Patients
-
- STATUS
- Recruiting
-
- participants needed
- 640
-
- sponsor
- Genzyme, a Sanofi Company
Summary
Primary Objective:
To determine the effect of venglustat on the rate of total
- and
estimated glomerular filtration rate (eGFR) decline in patients at risk of rapidly progressiveAutosomal 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
Autosomal Dominant PolycysticKidney Disease patients (Stages 1 and 2). - To determine the effect of venglustat on pain and
fatigue , based on patient reported diary (Stages 1 and 2). - Safety/tolerability objective:
- 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).
Description
Study duration per participant is 26 months (maximal) per stage, including a screening period
of 15 days, run-in period of 2 weeks, a 24-month treatment period, and a follow-up 30 days
after final dose of investigational
Details
Condition |
|
---|---|
Age | 18years - 55years |
Treatment | Placebo, venglustat GZ402671 |
Clinical Study Identifier | NCT03523728 |
Sponsor | Genzyme, a Sanofi Company |
Last Modified on | 19 February 2024 |
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