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
  Purpose

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


Condition Intervention Phase
Polycystic Kidney Disease, Autosomal Dominant
Drug: tolvaptan
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Rate of total kidney volume change(%) [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1445
Study Start Date: January 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tolvaptan 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
Placebo Comparator: Placebo 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428948

  Show 133 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT00428948     History of Changes
Other Study ID Numbers: 156-04-251, 2006-002768-24
Study First Received: January 26, 2007
Last Updated: February 1, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Argentina: Ministry of Health
Australia: Human Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: National Consultative Ethics Committee for Health and Life Sciences
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Belgium: Ethics Committee
Netherlands: Independent Ethics Committee
Poland: Ethics Committee
Romania: Ethics Committee
Russia: Ethics Committee
Japan: Ministry of Health, Labor and Welfare
Denmark: National Board of Health

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
ADPKD
Polycystic
kidney
ADPKD (Autosomal Dominant Polycystic Kidney Disease)

Additional relevant MeSH terms:
Kidney Diseases
Multicystic Dysplastic Kidney
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Congenital Abnormalities
Kidney Diseases, Cystic
Urogenital Abnormalities
Urologic Diseases

ClinicalTrials.gov processed this record on October 20, 2014