A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
Phase of Trial: Phase III
Latest Information Update: 28 Sep 2017
At a glance
- Drugs Tolvaptan (Primary)
- Indications Autosomal dominant polycystic kidney disease; Kidney disorders
- Focus Registrational; Therapeutic Use
- Acronyms REPRISE
- Sponsors Otsuka Pharmaceutical Development & Commercialization
- 22 May 2017 Status changed from active, no longer recruiting to completed, according to an Otsuka Pharmaceutical media release.
- 22 May 2017 According to an Otsuka Pharmaceutical media release, the trial results are intended to address the Complete Response Letter (CRL) issued by the FDA for a New Drug Application (NDA) for tolvaptan in ADPKD in 2013.
- 22 May 2017 According to an Otsuka Pharmaceutical media release, results from the trial will be submitted for presentation at a nephrology medical congress in the second half of 2017.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History