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: 26 Aug 2024

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At a glance

Drugs Tolvaptan (Primary) ; Tolvaptan (Primary)
Indications Autosomal recessive polycystic kidney disease
Focus Adverse reactions; Registrational
Sponsors Otsuka Pharmaceutical Development & Commercialization

Most Recent Events

13 Jan 2023 Planned number of patients changed from 20 to 10.
04 Oct 2022 Status changed from not yet recruiting to recruiting.
19 Aug 2022 Planned initiation date changed from 12 Aug 2022 to 31 Aug 2022.

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