Overview

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)

Status:
Not yet recruiting

Trial end date:
2025-07-01

Target enrollment:

Participant gender:

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)

Phase:

Phase 3

Details

Lead Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Treatments:

Tolvaptan