Trial Profile

A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 12 Weeks of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 13 Aug 2025

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At a glance

22 Jul 2025 Planned End Date changed from 11 Oct 2027 to 12 Apr 2029.
22 Jul 2025 Planned primary completion date changed from 11 Oct 2027 to 12 Apr 2029.
08 Aug 2022 Planned End Date changed from 17 May 2027 to 11 Oct 2027.

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