Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02160145 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,370
- Enrollment target
NCT02160145: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT02160145 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 1,370 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02160145, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,370 participants
- Enrollment target
Study Summary
The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD)
Primary Outcome
The mean annualized change in eGFR was calculated using the Chronic Kidney Disease-Epidemiology (CKD-EPI) formula from pretreatment baseline to post-treatment follow-up, annualized (divided) by each subject's trial duration. The baseline for the primary endpoint was defined as the average of up to 3 eGFR values observed during the screening and placebo run-in periods.
Interventions
- DRUG Placebo
- DRUG Tolvaptan (OPC-41061)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,370 participants |
| Start Date | 2014-05 |
| Est. Completion | 2017-04-18 |
| Phase | Phase 3 |
What the finished NCT02160145 record still lists
NCT02160145 is an interventional study that assigns participants to a tested intervention. Its 1,370 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02160145 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02160145 about?
NCT02160145 is a clinical study titled "Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease". The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD)
What is the current status of trial NCT02160145?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,370 participants. The study started on 2014-05. Estimated completion is 2017-04-18.
What interventions are being tested in trial NCT02160145?
The interventions under investigation include: Placebo (DRUG), Tolvaptan (OPC-41061) (DRUG).
Who is sponsoring clinical trial NCT02160145?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02160145's enrollment target sits among peer trials
1,370 177th of 2000 higher than 1,822 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
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
- NCT07256392 · 1,370 participants · Phase 3
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
- NCT04489238 · 1,366 participants
Collection of Information to Better Understand Young Onset Colorectal Cancer
- NCT02677064 · 1,365 participants
Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia
- NCT06651281 · 1,380 participants · Phase 3
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
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