Evaluation of Patiromer in Heart Failure Patients (PEARL-HF)
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| ClinicalTrials.gov Identifier: NCT00868439 |
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Recruitment Status :
Completed
First Posted : March 25, 2009
Results First Posted : December 15, 2015
Last Update Posted : June 2, 2021
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Sponsor:
Relypsa, Inc.
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Vifor Pharma ( Relypsa, Inc. )
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Brief Summary:
The purpose of this study was to assess the effects of patiromer on serum potassium participants with heart failure. This study also assessed the safety and tolerability of patiromer in participants with heart failure.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hyperkalemia Heart Failure | Drug: patiromer Drug: placebo | Phase 2 |
This was a double-blind, randomized, placebo-controlled, parallel-group, multiple-dose study in congestive heart failure participants. Depending on the outcome from the initial cohort of 100 participants (Part 1), a second cohort of 170 participants could have been enrolled (Part 2). Based on the results of Part 1 of the study, Part 2 was not conducted.
Participants were randomly assigned to and received patiromer (30 g/day) or placebo for up to 28 days. All participants also received spironolactone; the initial spironolactone dose was 25 mg daily and was increased to 50 mg daily for participants who had a serum potassium ≤ 5.1 mEq/L on treatment Day 14. Study visits occurred on treatment Days 3, 7, 14, 17, 21 and 28. A safety follow-up contact was made 7 days after administration of last dose of study drug.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Study to Evaluate the Effects of Patiromer in Heart Failure Patients |
| Study Start Date : | April 2009 |
| Actual Primary Completion Date : | November 2009 |
| Actual Study Completion Date : | December 2009 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Patiromer
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: patiromer |
Drug: patiromer
Active investigational drug
Other Names:
|
| Placebo Comparator: placebo |
Drug: placebo
placebo |
Primary Outcome Measures :
- Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period. [ Time Frame: Baseline and Day 28 ]
Secondary Outcome Measures :
- Proportion of Participants With a Serum Potassium Level During the 28-day Treatment Period That Was > 5.5 mEq/L. [ Time Frame: 28 Days ]Analysis based on central laboratory data.
- Proportion of Participants Discontinuing the Study Due to Serum Potassium Elevation (Serum K+ > 5.5 mEq/L). [ Time Frame: 28 Days ]Analysis based on local laboratory data.
- Proportion of Participants Whose Spironolactone Dose Was Increased. [ Time Frame: 28 Days ]
- Proportion of Participants With an Increase in Serum Potassium Level From Baseline to the End of the 28-day Treatment Period That Was ≥ 0.5 mEq/L [ Time Frame: Baseline and Day 28 ]
- Time to First Elevated Serum K+ > 5.5 mEq/L. [ Time Frame: 28 Days ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participants with chronic heart failure clinically indicated to receive spironolactone therapy, aged 18 years or older with serum potassium level of 4.3 - 5.1 mEq/L at screening and baseline, AND (1) chronic kidney disease (GFR < 60 mL/min) OR (2) documented history of hyperkalemia within the last 6 months
- Females of child-bearing potential must be non-lactating, must have a negative serum pregnancy test at screening, and must have used a highly effective form of contraception for at least 3 months before study drug administration, during the study, and for one month after study completion
- Male participants and/or their female partners of child-bearing potential must use a highly effective form of contraception during the study and for 3 months after study completion
- Must sign informed consent document
Exclusion Criteria:
- History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery
- Uncorrected hemodynamically significant primary valvular disease, known obstructive or restrictive cardiomyopathy, uncontrolled or hemodynamically unstable arrhythmia
- Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic), or major surgery including thoracic and cardiac, within 3 months prior to baseline or anticipated need during study participation
- Heart transplant recipient, or anticipated need for transplant during study participation
- Any of the following events having occurred within 3 months prior to baseline: unstable angina as judged by the Investigator, unresolved acute coronary syndrome, transient ischemic attack or stroke
- Current dialysis participant, or anticipated need for dialysis during study participation
- Prior kidney transplant, or anticipated need for transplant during study participation
- Metastatic, late-stage or end-stage cancer with < 12 months life expectancy
- History of alcoholism or drug/chemical abuse within 1 year
- QTcB interval > 500 msec (Bazett's correction formula)
- Sustained systolic blood pressure > 170 or < 90 mmHg
- Liver enzymes (ALT, AST) > 3 times upper limit of normal
- Use of oral cardiac medications (including loop and thiazide diuretics) that have not been stable for at least 21 days prior to baseline and are not anticipated to remain stable during study participation
- Use of any IV cardiac medications within 21 days prior to baseline, or their anticipated need during study participation.
- Current use of polymer-based drugs (e.g. Renagel, Kayexalate, Welchol, Colestid), other phosphate binders or potassium binders, calcium supplements, antacids (eg TUMS, Maalox), or their anticipated need during study participation
- Use of aldosterone antagonist in the last 30 days prior to baseline, unless was discontinued due to hyperkalemia
- Use of potassium sparing medication and/or potassium supplements in the last 30 days prior to baseline
- Use of any investigational medication, 30 days or 5 half-lives whichever is longer, prior to baseline
- Participants who have taken investigational product in this study, or a previous patiromer study
- Inability to consume the study medication, or, in the opinion of the Investigator, inability to comply with the protocol
- In the opinion of the Investigator, any medical condition, uncontrolled systemic disease, serious intercurrent illness, or extenuating circumstance occurring or persisting, within 30 days prior to baseline, that would significantly decrease study compliance or jeopardize the safety of the participant or affect the validity of the trial results
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): NCT00868439
Locations
Show 33 study locations
Sponsors and Collaborators
Relypsa, Inc.
Medpace, Inc.
Investigators
| Study Director: | Director Clinical Operations | Relypsa, Inc. |
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Relypsa, Inc. |
| ClinicalTrials.gov Identifier: | NCT00868439 |
| Other Study ID Numbers: |
RLY5016-202 |
| First Posted: | March 25, 2009 Key Record Dates |
| Results First Posted: | December 15, 2015 |
| Last Update Posted: | June 2, 2021 |
| Last Verified: | May 2021 |
Keywords provided by Vifor Pharma ( Relypsa, Inc. ):
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HF Heart failure hyperkalemia chronic kidney disease prevention of hyperkalemia in heart failure participants |
Additional relevant MeSH terms:
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Heart Failure Hyperkalemia Heart Diseases |
Cardiovascular Diseases Water-Electrolyte Imbalance Metabolic Diseases |