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)

Study Identifier:

156-12-204

ClinicalTrials.gov Identifier:

NCT04786574

EudraCT Identifier:

N/A

Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Contact Information:

240.683.3157 or [email protected]

Recruiting

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Study Details

Medical Condition

Kidney Disease

Study Drug

Drug: Tolvaptan (OPC-41061)

Date

Jul 2022 - Oct 2027

Phase 1

Phase 2

Phase 3

Phase 4

N/A

Patient Requirements

Sex: Female & Male

Age: 28 Days - 12 Weeks

Requirements Information

Protocol 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)

Study Locations

Location

Status

Location

Children's National Medical Center

Washington, District of Columbia, United States, 20010

Status

Recruiting

Location

Emory University

Atlanta, Georgia, United States, 30322

Status

Not yet recruiting

Location

Northwestern University Feinberg School of Medicine - Ann & Robert H. Lurie Children's Hospital of Chicago - Neonatology

Chicago, Illinois, United States, 60611

Status

Not yet recruiting

Location

Johns Hopkins Pediatric Specialty Clinic

Baltimore, Maryland, United States, 21287-0001

Status

Not yet recruiting

Location

C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States, 48109-5283

Status

Recruiting

Location

Mayo Clinic

Rochester, Minnesota, United States, 55905

Status

Not yet recruiting