Status: Recruiting

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

To evaluate the 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: Feb 17, 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... [+26]

Autosomal Recessive Polycystic Kidney (ARPKD)

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