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drugset / Trial / NCT04786574

A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

NCT04786574 ↗

Phase 3 Withdrawn Otsuka Pharmaceutical Development & Commercialization, Inc.
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the effect of tolvaptan on the need for renal replacement therapy in pediatric subjects with autosomal recessive polycystic kidney disease (ARPKD)

Timeline

Start
2022-07-01
Primary completion
2025-12-10
Completion
2025-12-10

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

Indications

autosomal recessive polycystic kidney disease