Status: Recruiting

A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

To evaluate the pharmacodynamics and safety of tolvaptan in pediatric subjects with ARPKD

Participants needed: 20

Trial details

Phase: Phase 3Age: 28-18Biological sex: AllType: InterventionalSponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.Updated: Aug 7, 2026Locations: 23

Eligibility criteria

Male or female subjects between 28 days and less than 18 years of age, with clin... [+1]

Premature birth (≤ 32 weeks gestational age) for infants 28 days to < 12 weeks o... [+29]

Autosomal Recessive Polycystic Kidney (ARPKD)

A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)