Efficacy and Safety of Tolvaptan 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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ClinicalTrials.gov Identifier: NCT02160145 |
Recruitment Status :
Completed
First Posted : June 10, 2014
Results First Posted : August 8, 2018
Last Update Posted : August 8, 2018
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Tracking Information | |||
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First Submitted Date ICMJE | June 6, 2014 | ||
First Posted Date ICMJE | June 10, 2014 | ||
Results First Submitted Date ICMJE | May 1, 2018 | ||
Results First Posted Date ICMJE | August 8, 2018 | ||
Last Update Posted Date | August 8, 2018 | ||
Study Start Date ICMJE | May 2014 | ||
Actual Primary Completion Date | April 18, 2017 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up. [ Time Frame: Pretreatment baseline to post-treatment follow-up (up to 61 weeks). ] The mean annualized change in eGFR was calculated using the Chronic Kidney Disease-Epidemiology (CKD-EPI) formula from pretreatment baseline to post-treatment follow-up, annualized (divided) by each subject's trial duration.
The baseline for the primary endpoint was defined as the average of up to 3 eGFR values observed during the screening and placebo run-in periods.
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Original Primary Outcome Measures ICMJE |
Treatment difference in the change of eGFR from pre-treatment baseline to post-treatment follow-up, normalized (divided) by each subject's treatment duration [ Time Frame: prior to and post 13 1/2 months of treatment ] | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
Mean Annualized Slope of eGFR Change [ Time Frame: Pretreatment baseline to post-treatment follow-up (up to 61 weeks). ] To compare the efficacy of tolvaptan treatment in reducing the decline of annualized eGFR slope, as compared with placebo, in subjects with late-stage CKD due to ADPKD who tolerated tolvaptan during an initial run-in period, the annualized rate of eGFR change was derived from each individual subject's eGFR slope using the CKD-EPI formula.
The annualized eGFR change slope was derived from all eGFR observations from placebo-run-in, tolvaptan run-in, double-blind treatment and post-treatment follow-up periods using the linear mixed model of analysis. The mean annualized slope of eGFR change is presented.
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease | ||
Official Title ICMJE | 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 | ||
Brief Summary | The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD) | ||
Detailed Description | The protocol will extend the understanding of the efficacy and safety of tolvaptan treatment in ADPKD patients with late stage 2 to early stage 4 CKD (chronic kidney disease). This trial will compare the efficacy of tolvaptan treatment in reducing the annualized change in estimated glomerular filtration rate (eGFR) from pre-treatment baseline to post-treatment follow-up, as compared with placebo, in subjects who tolerate tolvaptan during an initial run-in period. The change in eGFR, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) formula, will provide kidney function data that are complementary to the data demonstrating the benefits previously observed primarily in ADPKD subjects with earlier stages of disease. Also, it will compare the efficacy of tolvaptan treatment in reducing the decline of annualized eGFR slope, as compared with placebo, in this type of subjects. Finally, it will compare the overall and hepatic safety profile of tolvaptan with placebo and to compare incidence of ADPKD complications (outcomes) during the trial |
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Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
1370 | ||
Original Estimated Enrollment ICMJE |
1300 | ||
Actual Study Completion Date ICMJE | April 18, 2017 | ||
Actual Primary Completion Date | April 18, 2017 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Argentina, Australia, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, United Kingdom, United States | ||
Removed Location Countries | Czech Republic | ||
Administrative Information | |||
NCT Number ICMJE | NCT02160145 | ||
Other Study ID Numbers ICMJE | 156-13-210 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Otsuka Pharmaceutical Development & Commercialization, Inc. | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Otsuka Pharmaceutical Development & Commercialization, Inc. | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Otsuka Pharmaceutical Development & Commercialization, Inc. | ||
Verification Date | July 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |