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NCT04782258 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Autosomal Recessive Polycystic Kidney (ARPKD), sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
- 20
- Study locations
NCT04782258 is a Phase 3 study of Autosomal Recessive Polycystic Kidney (ARPKD) that is actively recruiting participants, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 20 participants. The trial reports 20 study locations across 18 states.
The verdict
NCT04782258, a Phase 3 study of Autosomal Recessive Polycystic Kidney (ARPKD), is actively recruiting participants, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the safety of tolvaptan in pediatric subjects with ARPKD
Conditions Studied
Interventions
- DRUG Tolvaptan Suspension
- DRUG Tolvaptan Tablets
Study Locations (20)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Cleveland Clinic - Cleveland
Barcelona
- Universitat de Barcelona - Hospital Sant Joan de Deu Barcelona (HSJDB) - Esplugues de Llobregat
- Hospital Universitari Parc Tauli - Sabadell
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Emory University Hospital - Atlanta
Illinois
- Northwestern University Feinberg School of Medicine - Ann & Robert H. Lurie Children's Hospital of Chicago - Neonatology - Chicago
Indiana
- Riley Hospital for Children - Indianapolis
Louisiana
- Children's Hospital - New Orleans - New Orleans
Maryland
- Johns Hopkins Pediatric Specialty Clinic - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-01-23 |
| Est. Completion | 2028-08-14 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04782258
The ClinicalTrials.gov registry entry for NCT04782258 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Autosomal Recessive Polycystic Kidney (ARPKD) appearing as the primary indexed condition, and to 2 interventions - of which Tolvaptan Suspension is the first listed.
NCT04782258 reports 20 study locations spanning 18 distinct geographic areas - top geographies include Ohio, Barcelona, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT04782258 about?
NCT04782258 is a clinical study titled "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)". To evaluate the safety of tolvaptan in pediatric subjects with ARPKD
What is the current status of trial NCT04782258?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2023-01-23. Estimated completion is 2028-08-14.
What conditions does trial NCT04782258 study?
This clinical trial studies the following conditions: Autosomal Recessive Polycystic Kidney (ARPKD).
What interventions are being tested in trial NCT04782258?
The interventions under investigation include: Tolvaptan Suspension (DRUG), Tolvaptan Tablets (DRUG).
Who is sponsoring clinical trial NCT04782258?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04782258 being conducted?
This trial has 20 study locations across District of Columbia, Georgia, Illinois, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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