A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL) (OPAL)
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|ClinicalTrials.gov Identifier: NCT01810939|
Recruitment Status : Completed
First Posted : March 14, 2013
Results First Posted : December 15, 2015
Last Update Posted : April 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease (CKD) Hyperkalemia (HK)||Drug: Patiromer Drug: Placebo||Phase 3|
There were two parts in the study, Part A and Part B.
Part A was an assessment of 4 weeks of dosing with patiromer in the treatment of hyperkalemia; Part B was a randomized, placebo-controlled, 8-week assessment of the withdrawal of patiromer in participants with a baseline serum potassium at the beginning of Part A ≥ 5.5 mEq/L who responded to the 4 weeks of treatment with patiromer during Part A.
All participants received patiromer during Part A; Part B participants were randomized to continue patiromer or switch to placebo. Total study participation was up to 14 weeks (including up to 2 weeks of follow up).
The dose of patiromer could be titrated based on participant's serum potassium response.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||243 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||August 2013|
Active Comparator: Patiromer
Patiromer was administered twice a day as a powder mixed with water.
Placebo Comparator: Placebo
Placebo was administered twice a day as a powder mixed with water.
- Change in Serum Potassium From Part A Baseline to Part A Week 4 [ Time Frame: Part A Baseline to Part A Week 4 ]The primary analysis endpoint is the change from Baseline at Week 4. The estimate of the change at Week 4 is from a repeated measures model, which includes data from Weeks 1, 2, 3 and 4. The analysis includes all intent to treat participants who had a serum potassium result at baseline and at least one weekly post-baseline visit (i.e. Part A Week 1 or later) and excludes six participants who had no result collected after Day 3).
- Change in Serum Potassium From Part B Baseline [ Time Frame: Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L ]
Change in Serum Potassium from Part B Baseline to either:
Part B Week 4 visit, if the participant's serum potassium remained ≥ 3.8 mEq/L and < 5.5 mEq/L up to the Part B Week 4 visit or the earliest Part B visit at which the participant's serum potassium was < 3.8 mEq/L or ≥ 5.5 mEq/L.
- Proportion of Participants With Serum Potassium Levels in the Target Range of 3.8 to < 5.1 mEq/L at Part A Week 4 [ Time Frame: Week 4 ]
- Proportion of Participants With Serum Potassium That Was ≥ 5.5 mEq/L in Part B [ Time Frame: Part B Baseline to Part B Week 8 ]
- Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B [ Time Frame: Part B Baseline to Part B Week 8 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810939
|Study Director:||Director Clinical Operations||Relypsa, Inc.|