Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01210560 · ClinicalTrials.gov registry record · Phase 2
Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD
A Phase 2 study of Autosomal Dominant Polycystic Kidney Disease, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 6
- Study locations
NCT01210560: Completed Phase 2 study of Autosomal Dominant Polycystic Kidney Disease, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01210560 is a Phase 2 study of Autosomal Dominant Polycystic Kidney Disease that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 25 participants, below the 159-participant average among 9 other Autosomal Dominant Polycystic Kidney Disease trials with a reported enrollment target (84% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01210560, a Phase 2 study of Autosomal Dominant Polycystic Kidney Disease, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 6
- Study locations
Study Summary
To establish pharmacokinetics (PK), pharmacodynamics (PD), and adverse event (AE) profile of tolvaptan administered as the modified-release (MR) formulation in ADPKD subjects. The goals of this trial are two-fold: 1. To directly compare the immediate release (IR) and MR formulations 2. To determine the dose range and dose regimen for MR (dose finding)
Primary Outcome
Blood samples (6 mL) for determination of tolvaptan PK parameters were collected on Day 1 predose, and on Days 7, 14 and 21 at predose, and 1, 2, 4, 6, 8, 9, 10, 12, 16, and 24 hours postdose. If a sample was not drawn at the designated time, a window of ± 3 minutes for each blood draw was acceptable. Maximum and minimum plasma concentration of the drug was calculated.
Conditions Studied
Interventions
- DRUG Tolvaptan MR
- DRUG Tolvaptan IR
Study Locations (6)
Minnesota
- Davita Clinical Research - Minneapolis
- Mayo Medical Center - Rochester
Massachusetts
- Tufts-New England Medical Center - Boston
Ohio
- University Hospitals of Cleveland/Case - Cleveland
Oregon
- Northwest Renal Clinic Inc. - Portland
Pennsylvania
- University of Pennsylvania Medical Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
What the finished NCT01210560 record still lists
NCT01210560 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 159-participant average among 9 other Autosomal Dominant Polycystic Kidney Disease trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Autosomal Dominant Polycystic Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Tolvaptan MR is the first listed.
NCT01210560 lists 6 locations in 5 states (Minnesota, Massachusetts, Ohio).
Frequently Asked Questions
What is clinical trial NCT01210560 about?
NCT01210560 is a clinical study titled "Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD". To establish pharmacokinetics (PK), pharmacodynamics (PD), and adverse event (AE) profile of tolvaptan administered as the modified-release (MR) formulation in ADPKD subjects. The goals of this trial are two-fold: 1. To directly compare the immediate release (IR) and MR formulations 2. To determine...
What is the current status of trial NCT01210560?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2010-10. Estimated completion is 2011-06.
What conditions does trial NCT01210560 study?
This clinical trial studies the following conditions: Autosomal Dominant Polycystic Kidney Disease.
What interventions are being tested in trial NCT01210560?
The interventions under investigation include: Tolvaptan MR (DRUG), Tolvaptan IR (DRUG).
Who is sponsoring clinical trial NCT01210560?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01210560 being conducted?
This trial has 6 study locations across Massachusetts, Minnesota, Ohio, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autosomal Dominant Polycystic Kidney Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01210560's enrollment target sits among peer trials
25 10th of 9 the lowest of 9 other Autosomal Dominant Polycystic Kidney Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autosomal Dominant Polycystic Kidney Disease 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
-
A Study to Assess Adverse Events and Effectiveness of IntraVenous Infusions of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
RECRUITING · Phase 2
-
Characterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
RECRUITING
-
NOX4 and Related Biomarkers in ADPKD
RECRUITING
-
Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease
RECRUITING · Phase 1
-
A Study to Evaluate Homocysteine Metabolism and Endothelial Function in ADPKD
ACTIVE NOT RECRUITING
-
Intrarenal Microvasculature in ADPKD
ACTIVE NOT RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01166854 · 25 participants
Characterization of Familial Myopathy and Paget Disease of Bone
- NCT01913106 · 25 participants · Phase 1
HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer
- NCT02138669 · 25 participants · NA
Intacs Prescription Inserts for Keratoconus Patients
- NCT02174549 · 25 participants · Phase 1
Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia