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)
Recruiting · Phase 3 · NCT04782258
Conditions: Autosomal Recessive Polycystic Kidney (ARPKD)
At a glance
- Research payments reported, 2025
- $205,326
- U.S. investigators named
- 8
- Sites paid
- 8
- Planned or actual enrollment
- 20
About the trial
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Tested
- Tolvaptan Suspension (drug), Tolvaptan Tablets (drug)
- Dates
- Started 2023-01-23; completion 2028-12-28
- Results posted
- Not yet
To evaluate the pharmacodynamics and safety of tolvaptan in pediatric subjects with ARPKD
From ClinicalTrials.gov, last updated 2026-10-23. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Otsuka Pharmaceutical Development & Commercialization, Inc. reported $205,326 in research payments for this study in 2025 (8 payments).
Products named: Tolvaptan
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Ashima Gulati, MD Pediatric Nephrology · Washington, DC
- Priya Verghese, MD Pediatric Nephrology · Chicago, IL
- Kera E. Luckritz, DO Pediatric Nephrology · Ann Arbor, MI
- Christian Hanna, MD Pediatric Nephrology · Rochester, MN
- Katherine M. Dell, MD Pediatric Nephrology · Cleveland, OH
- Michael Moritz Pediatric Nephrology · Akron, OH
- Meredith P. Schuh, M.D. Pediatric Nephrology · Cincinnati, OH
- Raoul D. Nelson Pediatric Nephrology · Salt Lake City, UT
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Cleveland Clinic, OH $76,385
- Cincinnati Children's Hospital Medical Center, OH $56,662
- Naprtcs $25,682
- University of Michigan Health System, MI $18,854
- Ann & Robert H Lurie Childrens Hospital of Chicago, IL $12,500
- Mayo Clinic $9,300
- University of Pittsburgh Physicians $4,299
- Childrens Research Institute $1,644
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.