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)

Study Identifier:

156-201-00307

ClinicalTrials.gov Identifier:

NCT04782258

EudraCT Identifier:

2020-005992-10

Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Contact Information:

844-687-8522 or [email protected]

Recruiting

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Study Details

Medical Condition

Kidney Disease

Study Drug

Drug: Tolvaptan Suspension
Drug: Tolvaptan Tablets

Date

Jul 2022 - Feb 2028

Phase 1

Phase 2

Phase 3

Phase 4

N/A

Patient Requirements

Sex: Female & Male

Age: 28 Days - 18 Years

Requirements Information

Protocol Summary

The primary objective of this study is to evaluate the safety of tolvaptan in pediatric subjects with autosomal recessive polycystic kidney disease (ARPKD)

Study Locations

Location

Status

Location

Research Site #104

Washington, District of Columbia, United States, 20010

Status

Recruiting

Location

Research Site #100

Atlanta, Georgia, United States, 30322

Status

Not yet recruiting

Location

Research Site #108

Chicago, Illinois, United States, 60611

Status

Recruiting

Location

Research Site #110

Indianapolis, Indiana, United States, 46202

Status

Recruiting

Location

Research Site #101

New Orleans, Louisiana, United States, 70118

Status

Withdrawn

Location

Research Site #113

Baltimore, Maryland, United States, 21205

Status

Recruiting