A Study to See Iftolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old withAutosomal Recessive Polycystic Kidney Disease (ARPKD)

ClinicalTrials.gov ID: NCT04782258

Public ClinicalTrials.gov record NCT04782258. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 19, 2026, 11:21 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 18 Years of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

Study identification

NCT ID: NCT04782258
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.; Industry
Enrollment: 20 participants

Conditions and interventions

Conditions

Autosomal Recessive Polycystic Kidney (ARPKD)

Interventions

Tolvaptan Suspension Drug
Tolvaptan Tablets Drug

Drug

Eligibility (public fields only)

Age range: 28 Days to 18 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 22, 2023
Primary completion: Jul 30, 2028
Completion: Aug 13, 2028
Last update posted: Feb 16, 2026

2023 – 2028

United States locations

U.S. sites: 12
U.S. states: 11
U.S. cities: 12

Facility	City	State	ZIP	Site status
Children's National Medical Center	Washington D.C.	District of Columbia	20010	Recruiting
Emory University Hospital	Atlanta	Georgia	30322	Withdrawn
Northwestern University Feinberg School of Medicine - Ann & Robert H. Lurie Children's Hospital of Chicago - Neonatology	Chicago	Illinois	60611	Withdrawn
Riley Hospital for Children	Indianapolis	Indiana	46202-5119	Withdrawn
Children's Hospital - New Orleans	New Orleans	Louisiana	70118	Withdrawn
Johns Hopkins Pediatric Specialty Clinic	Baltimore	Maryland	21287	Recruiting
C.S. Mott Children's Hospital	Ann Arbor	Michigan	48109-5000	Recruiting
Mayo Clinic - Rochester	Rochester	Minnesota	55905	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229-3039	Recruiting
Cleveland Clinic	Cleveland	Ohio	44195	Recruiting
Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	15213	Withdrawn
Primary Children's Hospital	Salt Lake City	Utah	84113	Withdrawn

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04782258, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 16, 2026 · Synced May 19, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04782258 live on ClinicalTrials.gov.

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