The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer treatment was also evaluated.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
243
Change in Serum Potassium From 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).
Time frame: Part A Baseline to Part A Week 4
Change in Serum Potassium From Part B Baseline
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.
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
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
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Investigator Site 3121
Azusa, California, United States
Investigator Site 3133
Los Angeles, California, United States
Investigator Site 3103
Sacramento, California, United States
Investigator Site 3129
Santa Barbara, California, United States
Investigator Site 3130
Ventura, California, United States
Investigator Site 3105
Edgewater, Florida, United States
Investigator Site 3113
Hollywood, Florida, United States
Investigator Site 3106
Port Charlotte, Florida, United States
Investigator Site 3120
Augusta, Georgia, United States
Investigator Site 3102
Farmington, Missouri, United States
...and 48 more locations