drugset / Trial / NCT04705051

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

NCT04705051

Phase 3 Terminated 24 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2021-02-09
Primary completion
2021-07-13
Completion
2021-07-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Venglustat Small molecule 15 mg Oral

Indications