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)
Withdrawn · Phase 3 · NCT04786574
Conditions: Autosomal Recessive Polycystic Kidney Disease (ARPKD)
At a glance
- Research payments reported, 2025
- $80,736
- U.S. investigators named
- 6
- Sites paid
- 6
About the trial
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Tested
- Tolvaptan (OPC-41061) (drug)
- Dates
- Started 2022-07-01; completion 2025-12-10
- Results posted
- Not yet
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)
From ClinicalTrials.gov, last updated 2025-12-24. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Otsuka Pharmaceutical Development & Commercialization, Inc. reported $80,736 in research payments for this study in 2025 (6 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
- Stuart Goldstein, MD 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
- Naprtcs $23,350
- University of Michigan Health System, MI $21,136
- Cincinnati Children's Hospital Medical Center, OH $14,000
- Mayo Clinic $8,400
- Childrens Research Institute $7,800
- Ann & Robert H Lurie Childrens Hospital of Chicago, IL $6,050
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.