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

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ClinicalTrials.gov Identifier: NCT01810939
Recruitment Status : Completed
First Posted : March 14, 2013
Results First Posted : December 15, 2015
Last Update Posted : April 11, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease (CKD) Hyperkalemia (HK) Drug: Patiromer Drug: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia
Study Start Date : February 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium
Drug Information available for: Patiromer

Arm Intervention/treatment
Active Comparator: Patiromer
Patiromer was administered twice a day as a powder mixed with water.
Drug: Patiromer
Other Names:
  • RLY5016 for Oral Suspension
  • Veltassa

Placebo Comparator: Placebo
Placebo was administered twice a day as a powder mixed with water.
Drug: Placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810939


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Sponsors and Collaborators
Relypsa, Inc.
Investigators
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Study Director: Director Clinical Operations Relypsa, Inc.

Additional Information:
Publications:
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Responsible Party: Relypsa, Inc.
ClinicalTrials.gov Identifier: NCT01810939     History of Changes
Other Study ID Numbers: RLY5016-301
2012-001956-20 ( EudraCT Number )
First Posted: March 14, 2013    Key Record Dates
Results First Posted: December 15, 2015
Last Update Posted: April 11, 2016
Last Verified: March 2016

Keywords provided by Relypsa, Inc.:
Chronic Kidney Disease
Treatment of Hyperkalemia
Hyperkalemia

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hyperkalemia
Urologic Diseases
Renal Insufficiency
Water-Electrolyte Imbalance
Metabolic Diseases