Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease
Status:
Recruiting
Trial end date:
2026-04-01
Target enrollment:
Participant gender:
Summary
This is a Phase 3 trial consisting of a 2-arm, double-blind, placebo-controlled, randomized
phase (Part 1) followed by a single-arm open-label phase (Part 2) to demonstrate the efficacy
and safety of lixivaptan in participants with autosomal dominant polycystic kidney disease
(ADPKD). Part 1 of the trial is designed to demonstrate the efficacy of lixivaptan in slowing
the decline in renal function as measured by the difference in estimated glomerular
filtration rate (eGFR) between the lixivaptan-treated and placebo-treated participants. Part
2 of the study is designed to provide confirmation of the durability of this effect.
Additionally, both parts of the study will contribute to understanding the safety of
lixivaptan, particularly any effects on liver chemistry tests.