Clinical Trial

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)

Recruiting Phase 3
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Summary
To evaluate the pharmacodynamics and safety of tolvaptan in pediatric subjects with ARPKD
Protocol Amendment History 16 amendments
This ClinicalTrials.gov record has been amended 16 times since 2021-03-03; most recent amendment 2026-07-13.
Status change: Not Yet Recruiting → Recruiting 2022-10-04
Trial Details
NCT Number NCT04782258
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions Autosomal Recessive Polycystic Kidney (ARPKD)
Enrollment 20 participants
Start Date 2023-01-23
Primary Completion 2028-07-31 (estimated)
Study Completion 2028-08-14 (estimated)
Updated on ClinicalTrials.gov 2026-08-07