Tolvaptan Phase 3 Efficacy and Safety Study in ADPKD (TEMPO3/4)

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00428948
First received: January 26, 2007
Last updated: February 1, 2013
Last verified: February 2013

January 26, 2007
February 1, 2013
January 2007
January 2012   (final data collection date for primary outcome measure)
Rate of total kidney volume change(%) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Evaluate long-term efficacy of tolvaptan in ADPKD through rate of renal volume change (%) for tolvaptan-treated compared to placebo-treated subjects.
Complete list of historical versions of study NCT00428948 on ClinicalTrials.gov Archive Site
  • Time to onset of multiple ADPKD outcomes [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    ADPKD outcomes include new onset hypertension, worsening hypertension, renal pain, worsening albuminuria and worsening renal function
  • Evaluate long-term efficacy of tolvaptan in ADPKD using single clinical 4-markers of ADPKD progression [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Evaluate long-term safety of tolvaptan through standard clinical measures. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Evaluate pharmacokinetic (PK), pharmacodynamic (PD) and exploratory parameters for tolvaptan in ADPKD. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
Tolvaptan Phase 3 Efficacy and Safety Study in ADPKD
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

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

The current study will evaluate whether tolvaptan will be potentially beneficial, while maintaining an adequate safety profile, by reducing the rate of total renal volume increase, while impacting the onset, severity and progression of other important consequences of ADPKD.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Polycystic Kidney Disease, Autosomal Dominant
  • Drug: tolvaptan
    oral tablet split-dose regimens (45/15mg, 60/30 mg or 90/30 mg) by mouth twice a day on awakening and approximately 9 hours later for 36 months. Daily dose regimen based on maximally tolerated dose.
    Other Name: OPC-41061 or OPC-156
  • Drug: Placebo
    oral tablet split-dose regimens (45/15mg Placebo, 60/30 mg Placebo or 90/30 mg Placebo) by mouth twice a day on awakening and approximately 9 hours later for 36 months. Daily dose regimen based on maximally tolerated dose.
  • Experimental: Tolvaptan
    Intervention: Drug: tolvaptan
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1445
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • GFR estimated at ≥60 mL/ min
  • Diagnosis of ADPKD and rapidly progressive kidney growth (total volume ≥750 cc) by Magnetic Resonance Imaging (MRI) at randomization
  • Legal adult age and able to give Informed Consent
  • Willingness to comply with reproductive precautions if female

Exclusion Criteria:

  • Prior exposure to tolvaptan or other experimental PKD therapies
  • Currently taking medication for purpose of affecting PKD cysts
  • Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods
  • In the opinion of the study investigator or sponsor may present a safety risk or confound study objectives
  • Patients who are unlikely to adequately comply with study procedures
  • Patients having contraindications to MRI
  • Patients taking medications or having any illnesses likely to affect ADPKD outcomes.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Canada,   Denmark,   France,   Germany,   Italy,   Japan,   Netherlands,   Poland,   Romania,   Russian Federation,   United Kingdom
 
NCT00428948
156-04-251, 2006-002768-24
Yes
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
Principal Investigator: Vicente Torres, MD, PhD Mayo Medical Center
Study Director: Frank Czerwiec, MD, PhD Otsuka Pharmaceutical Development and Commercialization, Inc.
Study Director: Osamu Sato Otsuka Pharmaceutical Corporation, Ltd. Japan
Otsuka Pharmaceutical Development & Commercialization, Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP