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Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (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: May 30, 2017
Last verified: May 2017
Results First Received: March 29, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Polycystic Kidney Disease, Autosomal Dominant
Interventions: Drug: Tolvaptan
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Intent-to-treat population: All randomized participants.

Reporting Groups
  Description
Tolvaptan Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
Placebo Participants received placebo (upon awakening and 9 hours later) orally for 36 months.

Participant Flow:   Overall Study
    Tolvaptan   Placebo
STARTED   961   484 
Received Treatment   961   483 
COMPLETED   740   417 
NOT COMPLETED   221   67 
Lost to Follow-up                15                8 
Adverse Event                148                24 
Subject Met Withdrawal Criteria                4                0 
Investigator Withdrew Subject                3                4 
Subject Withdrew Consent                50                30 
Protocol Deviation                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population: All randomized participants.

Reporting Groups
  Description
Tolvaptan Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
Placebo Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
Total Total of all reporting groups

Baseline Measures
   Tolvaptan   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 961   484   1445 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.6  (7.1)   38.8  (7.1)   38.7  (7.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      466  48.5%      233  48.1%      699  48.4% 
Male      495  51.5%      251  51.9%      746  51.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage Change Per Year in Total Kidney Volume From Baseline to Month 36   [ Time Frame: Baseline to Month 36 ]

2.  Secondary:   Number of ADPKD Clinical Progression Events Per 100 Follow-up Years From Baseline to Month 36   [ Time Frame: Baseline to Month 36 ]

3.  Secondary:   Change in Renal Function Per Year From Week 3 to Month 36   [ Time Frame: Week 3 to Month 36 ]

4.  Secondary:   Change in Mean Arterial Blood Pressure Per Year in Non-hypertensive Participants From Baseline to Month 36   [ Time Frame: Baseline to Month 36 ]

5.  Secondary:   Area Under the Concentration-time Curve of Change in Renal Pain From Baseline to Month 36   [ Time Frame: At screening, Baseline, Day 1, every 4 months up to month 36/early tremination (ET), follow-up visit 1 and 2 ]

6.  Secondary:   Number of Hypertensive Events Per 100 Follow-up Years in Non-hypertensive Participants From Baseline to Month 36   [ Time Frame: Baseline to Month 36 ]

7.  Secondary:   Percentage of Participants With a Clinically Sustained Decrease of Blood Pressure Leading to a Sustained Reduction in Antihypertensive Therapy From Baseline to Month 36   [ Time Frame: Baseline to Month 36 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization
phone: 800 562-3974


Publications:

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 ( EudraCT Number )
Study First Received: January 26, 2007
Results First Received: March 29, 2017
Last Updated: May 30, 2017