A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Kidney Disease (CKD), Hyperkalemia (HK)

In brief

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.

Key facts

Study ID

NCT01810939

Run by

Relypsa, Inc.

People needed

243

Starts

2013-02-01

Expected to finish

2013-08-01

Last updated by the study team

2021-06-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Investigator Site 3104 — Kansas City, Missouri, United States
• Investigator Site 3134 — Flushing, New York, United States
• Investigator Site 3107 — Bethlehem, Pennsylvania, United States
• Investigator Site 3110 — San Antonio, Texas, United States
• Investigator Site 1103 — Karlovac, Croatia
• Investigator Site 1102 — Osijek, Croatia
• Investigator Site 1104 — Zagreb, Croatia
• Investigator Site 1105 — Zagreb, Croatia
• Investigator Site 1106 — Zagreb, Croatia
• Investigator Site 1205 — Znojmo, Czechia
• Investigator Site 2103 — Aarhus N, Denmark
• Investigator Site 2107 — Fredericia, Denmark
• Investigator Site 2101 — Roskilde, Denmark
• Investigator Site 2105 — Viborg, Denmark
• Investigator Site 1308 — Tbilisi, Georgia
• Investigator Site 3121 — Azusa, California, United States

Full record on ClinicalTrials.gov

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