Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Keywords: Kidney Disease ADPKD Autosomal Dominant Polycystic Kidney Disease Adult Polycystic Kidney Disease
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1083
Healthy volunteers: no

Brief summary:
To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.

Detailed description:

Arms:
arm 1: Participants received a daily split-dose of tolvaptan titrated to the maximally tolerated dose, starting daily tolvaptan dose of 45 milligrams (mg) in the morning \[AM\]/15 mg in the evening \[PM\] titrated to 60 mg \[AM\]/30 mg \[PM\], then 90 mg \[AM\]/30 mg \[PM\] based on tolerability were given orally twice daily until the last participant originating from prior studies (either 156-04-251 or 156-04-250, 156-06-260, 156-09-284, 156-09-285, and 156-09-290) who was eligible for efficacy analysis completed the Month 24.

Interventions: intervention 1: Tolvaptan
Intervention descriptions: intervention 1: Tablets of 15 or 30 mg

Protocol document: