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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 May 2023

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At a glance

  • Drugs Tolvaptan (Primary)
  • Indications Autosomal dominant polycystic kidney disease
  • Focus Registrational; Therapeutic Use
  • Acronyms REPRISE
  • Sponsors Otsuka Pharmaceutical; Otsuka Pharmaceutical Development & Commercialization

Most Recent Events

  • 24 Mar 2023 Results deriving plasma samples from NCT02160145 for comparing changes in the plasma BA profiles in TOL-treated patients with and without ALT elevations.presented at the 124th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
  • 01 Mar 2023 Results assessing the clinical pattern and hepatic safety profile of tolvaptan in patients with autosomal dominant polycystic kidney disease from NCT00428948 (TEMPO 3:4), NCT01214421 (TEMPO 4:4), NCT02160145 (REPRISE), and NCT02251275 (long-term extension) studies, published in the American Journal of Kidney Diseases.
  • 07 Jan 2019 Mexico was planned location as per European Clinical Trials Database.

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