Evaluation of Patiromer in Heart Failure Patients (PEARL-HF)

This study has been completed.
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Relypsa, Inc.
ClinicalTrials.gov Identifier:
NCT00868439
First received: March 23, 2009
Last updated: November 11, 2015
Last verified: November 2015
  Purpose
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 Intervention Phase
Hyperkalemia
Heart Failure
Drug: patiromer
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Relypsa, Inc.:

Primary Outcome Measures:
  • Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Proportion of Participants Discontinuing the Study Due to Serum Potassium Elevation (Serum K+ > 5.5 mEq/L). [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Proportion of Participants Whose Spironolactone Dose Was Increased. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • 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: 28 Days ] [ Designated as safety issue: No ]
  • Time to First Elevated Serum K+ > 5.5 mEq/L. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: April 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: patiromer Drug: patiromer
Active investigational drug
Other Names:
  • RLY5016
  • Veltassa
Placebo Comparator: placebo Drug: placebo
placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868439

  Hide Study Locations
Locations
United States, Florida
Investigator Site 029
Miami, Florida, United States, 33176
Investigator Site 031
Port Charlotte, Florida, United States, 33952
United States, Illinois
Investigator Site 009
Peoria, Illinois, United States, 61606
United States, Minnesota
Investigator Site 018
Minneapolis, Minnesota, United States, 55417
United States, New York
Investigator Site 020
Buffalo, New York, United States, 14215
Investigator Site 005
Northport, New York, United States, 11768
United States, Ohio
Investigator Site 022
Columbus, Ohio, United States, 43210
United States, Texas
Investigator Site 001
Dallas, Texas, United States, 75216
United States, Utah
Investigator Site 019
Salt Lake City, Utah, United States, 84124
Czech Republic
Investigator Site 102
Brno, Czech Republic, 62500
Investigator Site 104
Prague, Czech Republic, 12008
Investigator Site 103
Prague, Czech Republic, 14021
Georgia
Investigator Site 604
Tblisi, Georgia, 0164
Investigator Site 602
Tblisi, Georgia, 0159
Investigator Site 603
Tblisi, Georgia, 0179
Investigator Site 605
Tblisi, Georgia, 0102
Germany
Investigator Site 201
Gottingen, Germany, 37075
Investigator Site 202
Heidelberg, Germany, 69120
Poland
Investigator Site 305
Warsaw, Poland, 02637
Russian Federation
Investigator Site 409
Barnaul, Russian Federation, 656099
Investigator Site 407
Kemerovo, Russian Federation, 650002
Investigator Site 403
Moscow, Russian Federation, 129301
Investigator Site 402
Moscow, Russian Federation, 111539
Investigator Site 406
Moscow, Russian Federation, 111020
Investigator Site 404
St Petersburg, Russian Federation, 197341
Investigator Site 412
St Petersburg, Russian Federation, 198205
Investigator Site 405
St Petersburg, Russian Federation, 199106
Ukraine
Investigator Site 507
Dnipropetrovsk, Ukraine, 49023
Investigator Site 502
Kharkiv, Ukraine, 61018
Investigator Site 509
Kharkiv, Ukraine, 61176
Investigator Site 504
Kiev, Ukraine, 03680
Investigator Site 506
Kiev, Ukraine, 03680
Investigator Site 501
Kiev, Ukraine, 04114
Sponsors and Collaborators
Relypsa, Inc.
Medpace, Inc.
Investigators
Study Director: Director Clinical Operations Relypsa, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Relypsa, Inc.
ClinicalTrials.gov Identifier: NCT00868439     History of Changes
Other Study ID Numbers: RLY5016-202 
Study First Received: March 23, 2009
Results First Received: November 11, 2015
Last Updated: November 11, 2015
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health
Georgia: Ministry of Health
Russia: Ministry of Health of the Russian Federation
United States: Institutional Review Board
Czech Republic: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ethics Committee
Russia: Ethics Committee
Ukraine: Ethics Committee
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Relypsa, Inc.:
HF
Heart failure
hyperkalemia
chronic kidney disease
prevention of hyperkalemia in heart failure participants

Additional relevant MeSH terms:
Heart Failure
Hyperkalemia
Cardiovascular Diseases
Heart Diseases
Metabolic Diseases
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on February 04, 2016