Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease
Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
This is a Phase 3, open-label, repeat-dose study designed to assess liver safety, non-liver
safety, and efficacy in subjects who previously experienced liver chemistry test
abnormalities while treated with tolvaptan and were permanently discontinued from the drug
for that reason. Up to 50 eligible subjects will be enrolled and treated with lixivaptan for
52 weeks following titration to an optimal dose.