Status:
COMPLETED
A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)
Lead Sponsor:
Relypsa, Inc.
Conditions:
Chronic Kidney Disease (CKD)
Hyperkalemia (HK)
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 wi...
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-wee...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT01810939
Start Date
February 1 2013
End Date
August 1 2013
Last Update
June 3 2021
Active Locations (58)
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1
Investigator Site 3121
Azusa, California, United States, 91702
2
Investigator Site 3133
Los Angeles, California, United States, 90025
3
Investigator Site 3103
Sacramento, California, United States, 95825
4
Investigator Site 3129
Santa Barbara, California, United States, 93110