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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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Chronic Kidney Disease Autosomal Dominant Polycystic Kidney Disease |
Interventions |
Drug: Tolvaptan (OPC-41061) Drug: Placebo |
Enrollment | 1370 |
Recruitment Details | First subject first visit: 21 May 2014; Last subject last visit: 18 April 2017. Subjects were recruited from 213 sites in 21 countries. Of 2292 subjects screened, 1519 entered the 6-week run-in period; 23 were placebo run-in failures and 126 were tolvaptan titration/run-in failures. |
Pre-assignment Details | Subjects with Stage 2 - 4 chronic kidney disease (CKD) due to Autosomal Dominant Polycystic Kidney Disease (ADPKD) were stratified by baseline estimated glomerular filtration rate (eGFR) (≤ 45 or > 45 milliliters/minute/ 1.73 square metres [mL/min/1.73 m^2]), by age (≤ 55 or > 55 years), and total kidney volume (≤ 2000 mL, > 2000 mL, or unknown). |
Arm/Group Title | All Subjects Prerandomization | Tolvaptan | Placebo |
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Following screening, the single-blind prerandomization period (Day -42 to Day -1) consisted of:
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Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects continued on the same dose of tolvaptan they received during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months. Follow-up Period: A 3-week final follow-up for efficacy analysis. |
Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects received placebo tablets matching their tolerated tolvaptan dose during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months. Follow-up Period: A 3-week final follow-up for efficacy analysis. |
Period Title: Prerandomization Single-blind Period | |||
Started | 1519 | 0 | 0 |
Treated in Placebo Run-in | 1514 | 0 | 0 |
Treated in Tolvaptan Titration/Run-in | 1491 | 0 | 0 |
Randomized | 1370 | 0 | 0 |
Completed | 1370 | 0 | 0 |
Not Completed | 149 | 0 | 0 |
Reason Not Completed | |||
Placebo run-in failure | 23 | 0 | 0 |
Tolvaptan titration/run-in failure | 126 | 0 | 0 |
Period Title: Randomized Double-blind Period | |||
Started | 0 [1] | 683 [2] | 687 [3] |
On-treatment Completers | 0 | 578 | 637 |
Off-treatment Completers | 0 | 76 | 22 |
Completed [4] | 0 | 654 | 659 |
Not Completed | 0 | 29 | 28 |
Reason Not Completed | |||
Subject decision | 0 | 21 | 20 |
Lost to Follow-up | 0 | 1 | 3 |
Physician Decision | 0 | 7 | 5 |
[1]
1370 subjects were randomized to receive tolvaptan or placebo in the double-blind period.
[2]
Subjects completed the single-blind period and were randomized to receive tolvaptan.
[3]
Subjects completed the single-blind period and were randomized to receive placebo.
[4]
Completed Month 12 Visit
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Arm/Group Title | Tolvaptan | Placebo | Total Title | |
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Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects continued on the same dose of tolvaptan they received during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months. Follow-up Period: A 3-week final follow-up for efficacy analysis. |
Double-blind Randomized Treatment Period (Day 0 to Month 12): Following randomization subjects received placebo tablets matching their tolerated tolvaptan dose during the tolvaptan run-in period (60/30 mg or 90/30 mg) for a duration of 12 months. Follow-up Period: A 3-week final follow-up for efficacy analysis. |
[Not Specified] | |
Overall Number of Baseline Participants | 683 | 687 | 1370 | |
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The baseline population consisted of all randomized subjects.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 683 participants | 687 participants | 1370 participants | |
47.3 (8.2) | 47.2 (8.2) | 47.3 (8.2) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 683 participants | 687 participants | 1370 participants | |
Female |
336 49.2%
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354 51.5%
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690 50.4%
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Male |
347 50.8%
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333 48.5%
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680 49.6%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 683 participants | 687 participants | 1370 participants | |
Hispanic or Latino |
44 6.4%
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35 5.1%
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79 5.8%
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Not Hispanic or Latino |
632 92.5%
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647 94.2%
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1279 93.4%
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Unknown or Not Reported |
7 1.0%
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5 0.7%
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12 0.9%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 683 participants | 687 participants | 1370 participants | |
American Indian or Alaska Native |
3 0.4%
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1 0.1%
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4 0.3%
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Asian |
22 3.2%
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19 2.8%
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41 3.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
25 3.7%
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23 3.3%
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48 3.5%
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White |
626 91.7%
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632 92.0%
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1258 91.8%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
7 1.0%
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12 1.7%
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19 1.4%
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Name/Title: | Global Clinical Devlopment |
Organization: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
Phone: | 609 524 6788 |
EMail: | clinicaltransparency@otsuka-us.com |
Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
ClinicalTrials.gov Identifier: | NCT02160145 |
Other Study ID Numbers: |
156-13-210 |
First Submitted: | June 6, 2014 |
First Posted: | June 10, 2014 |
Results First Submitted: | May 1, 2018 |
Results First Posted: | August 8, 2018 |
Last Update Posted: | August 8, 2018 |