8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

NCT01451827 ↗

Phase 2 Completed 178 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to compare the short-term effects of two tolvaptan formulations in patients with ADPKD.

Timeline

Start: 2011-10
Primary completion: 2013-07
Completion: 2013-07

Outcome

Met primary endpoint

registry analysis (superiority or other test); Tolvaptan MR 80 mg vs Placebo; p = 0.0108; Ratio of geometric means 0.97 (95% CI 0.95 to 0.99); ANCOVA NCT01451827 ↗

registry analysis (superiority or other test); Tolvaptan MR 50 mg vs Placebo; p = 0.0155; Ratio of geometric means 0.98 (95% CI 0.96 to 1.00); ANCOVA NCT01451827 ↗

Publications

St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tolvaptan	Unknown	30 mg	—
Subject	Tolvaptan	Unknown	50 mg	—
Subject	Tolvaptan	Unknown	60 mg	—
Subject	Tolvaptan	Unknown	80 mg	—