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NCT Number: NCT01810939

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

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.

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Key information

Conditions

Chronic Kidney Disease (CKD) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperkalemia Hyperkalemia (HK) Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Water-Electrolyte Imbalance

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigator Site 1103, Karlovac, Croatia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patiromer

Drug

Other names: RLY5016 for Oral Suspension, Veltassa

Placebo

Drug

Primary outcomes

  1. Change in Serum Potassium From Part A Baseline to Part A Week 4

    Time frame: 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).

  2. Change in Serum Potassium From Part B Baseline

    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

    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 outcomes

  1. 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

  2. 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

  3. Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B

    Time frame: Part B Baseline to Part B Week 8

Sponsors and collaborators

Lead sponsor

Relypsa, Inc.

Industry

Registry information

Official study title

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

Acronym: OPAL

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 14, 2013
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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