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"TEMPO 3/4 Trial" Tolvaptan Efficacy and Safety in Management of Polycystic Kidney Disease and Its Outcomes (Phase 3 of 4)

This study is currently recruiting participants.
Verified by Otsuka Pharmaceutical Development & Commercialization, Inc. September 2007

Sponsors and Collaborators:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Otsuka Pharmaceutical Co., Ltd.

Information provided by:

Otsuka Pharmaceutical Development & Commercialization, Inc.

ClinicalTrials.gov Identifier:




This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo.




Polycystic Kidney Disease, Autosomal Dominant

 Drug: Tolvaptan (AKA: OPC-41061 and OPC-156)

Phase III

MedlinePlus related topics:  Kidney Diseases
Genetics Home Reference related topics:  Kidney Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Phase 3, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Arm Trial to Determine Long-Term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease

Primary Outcome Measures: 

  • Evaluate long-term efficacy of tolvaptan in ADPKD through rate of renal volume change (%) for tolvaptan-treated compared to placebo-treated subjects.

Secondary Outcome Measures: 

  • Evaluate long-term efficacy of tolvaptan in ADPKD through a composite of ADPKD progression clinical markers (ie, hypertension, renal pain, albuminuria and renal function).
  • Evaluate long-term efficacy of tolvaptan in ADPKD using single clinical 4-markers of ADPKD progression
  • Evaluate long-term safety of tolvaptan through standard clinical measures.
  • Evaluate pharmacokinetic (PK), pharmacodynamic (PD) and exploratory parameters for tolvaptan in ADPKD.

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Total Enrollment:  1500

Study start: January 2007

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a genetic disorder characterized by the formation of fluid-filled cysts in the kidneys. The accumulation of these cysts enlarges the kidneys, impairing renal function and may lead to renal failure requiring dialysis or transplantation. This disease can be life-threatening. Aside from early antihypertensive control and dietary protein restriction, which may offer a modest degree of protection, most surviving patients require renal replacement therapy (dialysis and transplant) and suffer from high morbidity and mortality.2 Tolvaptan is an oral vasopressin (water regulating hormone) inhibitor acting principally at the kidney cells affected by ADPKD. A rationale for use of tolvaptan in ADPKD is supported by research conducted in a variety of animal models. In these models, tolvaptan is effective in halting or reversing the progression of this renal disease. ,

The current study will evaluate whether tolvaptan will be potentially beneficial, while maintaining an adequate safety profile, by reducing total renal volume and other important consequences of the disease.



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