Evaluation of Patiromer in Heart Failure Patients

NCT ID: NCT00868439

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-12-31

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.

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.

Conditions

Hyperkalemia; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

patiromer

Group Type: ACTIVE_COMPARATOR

patiromer

Intervention Type: DRUG

Active investigational drug

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo

Interventions

patiromer

Active investigational drug

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

Other Intervention Names

RLY5016; Veltassa

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medpace, Inc.

INDUSTRY

Sponsor Role: collaborator

Relypsa, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Director Clinical Operations

Role: STUDY_DIRECTOR

Relypsa, Inc.

Locations

Investigator Site 029

Miami, Florida, United States

Investigator Site 031

Port Charlotte, Florida, United States

Investigator Site 009

Peoria, Illinois, United States

Investigator Site 018

Minneapolis, Minnesota, United States

Investigator Site 020

Buffalo, New York, United States

Investigator Site 005

Northport, New York, United States

Investigator Site 022

Columbus, Ohio, United States

Investigator Site 001

Dallas, Texas, United States

Investigator Site 019

Salt Lake City, Utah, United States

Investigator Site 102

Brno, , Czechia

Investigator Site 104

Prague, , Czechia

Investigator Site 103

Prague, , Czechia

Investigator Site 605

Tbilisi, , Georgia

Investigator Site 602

Tbilisi, , Georgia

Investigator Site 604

Tbilisi, , Georgia

Investigator Site 603

Tbilisi, , Georgia

Investigator Site 201

Göttingen, , Germany

Investigator Site 202

Heidelberg, , Germany

Investigator Site 305

Warsaw, , Poland

Investigator Site 409

Barnaul, , Russia

Investigator Site 407

Kemerovo, , Russia

Investigator Site 406

Moscow, , Russia

Investigator Site 402

Moscow, , Russia

Investigator Site 403

Moscow, , Russia

Investigator Site 404

Saint Petersburg, , Russia

Investigator Site 412

Saint Petersburg, , Russia

Investigator Site 405

Saint Petersburg, , Russia

Investigator Site 507

Dnipropetrovsk, , Ukraine

Investigator Site 502

Kharkiv, , Ukraine

Investigator Site 509

Kharkiv, , Ukraine

Investigator Site 504

Kiev, , Ukraine

Investigator Site 506

Kiev, , Ukraine

Investigator Site 501

Kiev, , Ukraine

Countries

United States; Czechia; Georgia; Germany; Poland; Russia; Ukraine

References

Pitt B, Anker SD, Bushinsky DA, Kitzman DW, Zannad F, Huang IZ; PEARL-HF Investigators. Evaluation of the efficacy and safety of RLY5016, a polymeric potassium binder, in a double-blind, placebo-controlled study in patients with chronic heart failure (the PEARL-HF) trial. Eur Heart J. 2011 Apr;32(7):820-8. doi: 10.1093/eurheartj/ehq502. Epub 2011 Jan 5.

Reference Type: RESULT

PMID: 21208974 (View on PubMed)

Natale P, Palmer SC, Ruospo M, Saglimbene VM, Strippoli GF. Potassium binders for chronic hyperkalaemia in people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Jun 26;6(6):CD013165. doi: 10.1002/14651858.CD013165.pub2.

Reference Type: DERIVED

PMID: 32588430 (View on PubMed)

Other Identifiers

RLY5016-202

Identifier Type: -

Identifier Source: org_study_id