A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)
- Conditions
- Hyperkalemia (HK)Chronic Kidney Disease (CKD)
- Interventions
- Drug: Placebo
- Registration Number
- NCT01810939
- Lead Sponsor
- Relypsa, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 243
- Males and females ages 18 - 80
- Chronic kidney disease (CKD) - eGFR 15 to < 60 mL/min/1.73m2 at screening
- Hyperkalemia, defined as a serum potassium value of 5.1 to < 6.5 mEq/L at screening
- Taking either an Angiotensin-Converting Enzyme (ACE) Inhibitor, an Angiotensin II receptor blocker (ARB), or an aldosterone antagonist (AA) medication
- Informed consent given
- Participants with auto-immune related chronic kidney disease such as lupus nephritis or renal scleroderma/scleroderma renal crisis, or mixed connective tissue disease with renal involvement
- Participants with uncontrolled Type 1 diabetes, defined as or a HbA1c > 10.0 %, or hospitalization to treat hyper- or hypo-glycemia in the past 3 months within the previous 6 months in participants with Type 2 diabetes
- Participants with severe heart failure, defined as NYHA (New York Heart Association) class IV
- Participants with major surgery including thoracic and cardiac, in the past 3 months, or participants with heart or kidney transplant
- Participants with significant cardiovascular or cerebrovascular events in the past 2 months, such as cardiac arrest, myocardial infarction, or stroke
- Participants with BMI ≥ 40 kg/m2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo was administered twice a day as a powder mixed with water. Patiromer Patiromer Patiromer was administered twice a day as a powder mixed with water.
- Primary Outcome Measures
Name Time Method Change in Serum Potassium From Part A Baseline to Part A Week 4 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 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.
- Secondary Outcome Measures
Name Time Method Proportion of Participants With Serum Potassium Levels in the Target Range of 3.8 to < 5.1 mEq/L at Part A Week 4 Week 4 Proportion of Participants With Serum Potassium That Was ≥ 5.5 mEq/L in Part B Part B Baseline to Part B Week 8 Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B Part B Baseline to Part B Week 8
Trial Locations
- Locations (58)
Investigator Site 1105
🇭🇷Zagreb, Croatia
Investigator Site 1312
🇬🇪Tbilisi, Georgia
Investigator Site 1106
🇭🇷Zagreb, Croatia
Investigator Site 1103
🇭🇷Karlovac, Croatia
Investigator Site 1302
🇬🇪Tbilisi, Georgia
Investigator Site 1305
🇬🇪Tbilisi, Georgia
Investigator Site 1304
🇬🇪Tbilisi, Georgia
Investigator Site 1104
🇭🇷Zagreb, Croatia
Investigator Site 1301
🇬🇪Tbilisi, Georgia
Investigator Site 1309
🇬🇪Tbilisi, Georgia
Investigator Site 1310
🇬🇪Tbilisi, Georgia
Investigator Site 1410
🇭🇺Balatonfured, Hungary
Investigator Site 1401
🇭🇺Gyor, Hungary
Investigator Site 1406
🇭🇺Hatvan, Hungary
Investigator Site 1306
🇬🇪Tbilisi, Georgia
Investigator Site 1904
🇺🇦Kharkiv, Ukraine
Investigator Site 1903
🇺🇦Kharkiv, Ukraine
Investigator Site 1909
🇺🇦Kyiv, Ukraine
Investigator Site 3133
🇺🇸Los Angeles, California, United States
Investigator Site 3113
🇺🇸Hollywood, Florida, United States
Investigator Site 3106
🇺🇸Port Charlotte, Florida, United States
Investigator Site 3102
🇺🇸Farmington, Missouri, United States
Investigator Site 3120
🇺🇸Augusta, Georgia, United States
Investigator Site 3107
🇺🇸Bethlehem, Pennsylvania, United States
Investigator Site 3134
🇺🇸Flushing, New York, United States
Investigator Site 1205
🇨🇿Znojmo, Czechia
Investigator Site 1308
🇬🇪Tbilisi, Georgia
Investigator Site 1307
🇬🇪Tbilisi, Georgia
Investigator Site 1311
🇬🇪Tbilisi, Georgia
Investigator Site 1303
🇬🇪Tbilisi, Georgia
Investigator Site 1802
🇸🇮Celje, Slovenia
Investigator Site 1415
🇭🇺Budapest, Hungary
Investigator Site 1703
🇷🇸Belgrade, Serbia
Investigator Site 1710
🇷🇸Vrsac, Serbia
Investigator Site 1405
🇭🇺Jaszbereny, Hungary
Investigator Site 1707
🇷🇸Zrenjanin, Serbia
Investigator Site 1803
🇸🇮Jesenice, Slovenia
Investigator Site 1915
🇺🇦Ivano-Frankivsk, Ukraine
Investigator Site 1908
🇺🇦Kharkiv, Ukraine
Investigator Site 1914
🇺🇦Lugansk, Ukraine
Investigator Site 1911
🇺🇦Kyiv, Ukraine
Investigator Site 1907
🇺🇦Zaporizhzhia, Ukraine
Investigator Site 1906
🇺🇦Zaporizhzhia, Ukraine
Investigator Site 2201
🇮🇹Pavia, Italy
Investigator Site 2107
🇩🇰Fredericia, Denmark
Investigator Site 2101
🇩🇰Roskilde, Denmark
Investigator Site 2105
🇩🇰Viborg, Denmark
Investigator Site 1411
🇭🇺Kistarcsa, Hungary
Investigator Site 1407
🇭🇺Veszprem, Hungary
Investigator Site 3105
🇺🇸Edgewater, Florida, United States
Investigator Site 3121
🇺🇸Azusa, California, United States
Investigator Site 3130
🇺🇸Ventura, California, United States
Investigator Site 3129
🇺🇸Santa Barbara, California, United States
Investigator Site 1102
🇭🇷Osijek, Croatia
Investigator Site 2103
🇩🇰Aarhus N, Denmark
Investigator Site 3103
🇺🇸Sacramento, California, United States
Investigator Site 3104
🇺🇸Kansas City, Missouri, United States
Investigator Site 3110
🇺🇸San Antonio, Texas, United States