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

Relypsa

Status and phase

Completed

Phase 3

Conditions

Hyperkalemia (HK)

Chronic Kidney Disease (CKD)

Treatments

Drug: Patiromer

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01810939

RLY5016-301

2012-001956-20 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

243 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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