drugset
drugset / Trial / NCT04782258

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)

NCT04782258 ↗

Phase 3 Recruiting 20 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start
2023-01-23
Primary completion
2028-07-31
Completion
2028-08-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Tolvaptan Small molecule 0.15 mg/kg Oral
Subject Tolvaptan Small molecule 0.3 mg/kg Oral
Subject Tolvaptan Small molecule 0.5 mg/kg Oral
Subject Tolvaptan Small molecule 0.75 mg/kg Oral
Subject Tolvaptan Small molecule 1 mg/kg Oral
Subject Tolvaptan Small molecule 15 mg Oral
Subject Tolvaptan Small molecule 30 mg Oral
Subject Tolvaptan Small molecule 45 mg Oral

Indications

autosomal recessive polycystic kidney disease