Trial intelligence / Profile preview

Tolvaptan in Infants and Young Children With ARPKD

2023-508217-17-00Phase 3Completed

Sponsor
Otsuka Pharmaceutical Co., Ltd.
Start
Apr 2024
Modality
Small Molecules
Countries
6
01

Overview

Phase 3, open-label, single-arm trial of tolvaptan in autosomal recessive polycystic kidney disease (ARPKD), sponsored by Otsuka Pharmaceutical Co., Ltd. Primary endpoint: Primary efficacy: Percentage of subjects having renal replacement therapy (RRT) by 1 year of age. Started Apr 2024; status: completed.

02

Drugs

tolvaptan
03

Conditions

autosomal recessive polycystic kidney disease (ARPKD)

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