8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
(NOCTURNE Trial)
Recruiting in Palo Alto (17 mi)
+33 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study is to compare the short-term effects of two tolvaptan formulations in patients with ADPKD.
Research Team
FC
Frank Czerwiec, M.D., Ph.D.
Principal Investigator
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility Criteria
Inclusion Criteria
Age 18 to 50
BMI between 19 and 35 kg/m2
family history: 3cysts/kidney if by sonography or 5 by CT or MRI
See 5 more
Treatment Details
Interventions
- Placebo (Drug)
- Tolvaptan IR (Vasopressin V2 Receptor Antagonist)
- Tolvaptan MR (Vasopressin V2 Receptor Antagonist)
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Tolvaptan MR 80 mgExperimental Treatment2 Interventions
Tolvaptan MR 80 mg capsule and 2 placebo IR tablets (8 AM) and 1 placebo IR tablet (4 PM) daily.
Group II: Tolvaptan MR 50 mgExperimental Treatment2 Interventions
Tolvaptan MR 50 mg capsule and 2 placebo IR tablets ( 8 AM) and 1 placebo IR tablet (4 PM) daily.
Group III: Tolvaptan IR 60/30 mgExperimental Treatment2 Interventions
Two tolvaptan IR 30-mg tablets and 1 placebo MR capsule (8 AM) and 1 tolvaptan IR 30-mg tablet (4 PM) daily.
Group IV: PlaceboPlacebo Group1 Intervention
Placebo MR capsule and 2 placebo IR tablets (8 AM) and 1 placebo IR tablet (4 PM) daily.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead Sponsor
Trials
271
Recruited
170,000+
John Kraus
Otsuka Pharmaceutical Development & Commercialization, Inc.
Chief Medical Officer since 2023
MD, PhD
Tarek Rabah
Otsuka Pharmaceutical Development & Commercialization, Inc.
Chief Executive Officer since 2022
BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University