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)
Latest Information Update: 16 Jul 2024
At a glance
- Drugs Tolvaptan (Primary) ; Tolvaptan (Primary)
- Indications Autosomal recessive polycystic kidney disease
- Focus Registrational; Therapeutic Use
- Sponsors Otsuka Pharmaceutical Development & Commercialization
- 08 Aug 2022 Planned End Date changed from 17 May 2027 to 11 Oct 2027.
- 08 Aug 2022 Planned primary completion date changed from 17 May 2027 to 11 Oct 2027.
- 08 Aug 2022 Status changed from not yet recruiting to recruiting.