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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: Recruiting Phase 3 study of Autosomal Recessive Polycystic Kidney (ARPKD), sponsored by Otsuka Pharmaceutical Development & Commercialization.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Number of participants with TEAEs will be assessed from Baseline to post-treatment after 24 months or End of Treatment (EOTx). The EOTx visit applies to participants who discontinue IMP before Month 24. TEAEs are defined as Adverse Events (AEs) with an onset date on or after the start of Investigational Medicinal Product (IMP) treatment. TEAEs are also events continuous from baseline which worsened, became serious, were IMP related, or resulted in death, discontinuation, interruption, or reducti
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 |
What NCT04782258 shows while recruiting
NCT04782258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
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 names 20 study sites across 18 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04782258's enrollment target sits among peer trials
20 1957th of 2000 higher than 32 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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