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 18 Years of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 19 Feb 2026

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At a glance

21 Jan 2026 Planned End Date changed from 23 Feb 2028 to 14 Aug 2028.
21 Jan 2026 Planned primary completion date changed from 23 Feb 2028 to 31 Jul 2028.
18 Apr 2025 Planned number of patients changed from 10 to 20.

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