Heart Failure Clinical Trial

Evaluation of Patiromer in Heart Failure Patients

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT00868439

Recruitment Status:

Completed

Sponsor:

Relypsa, Inc.

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There are 32 Locations for this study

See Locations Near You

Investigator Site 029
Miami Florida, 33176, United States
Investigator Site 031
Port Charlotte Florida, 33952, United States
Investigator Site 009
Peoria Illinois, 61606, United States
Investigator Site 018
Minneapolis Minnesota, 55417, United States
Investigator Site 020
Buffalo New York, 14215, United States
Investigator Site 005
Northport New York, 11768, United States
Investigator Site 022
Columbus Ohio, 43210, United States
Investigator Site 001
Dallas Texas, 75216, United States
Investigator Site 019
Salt Lake City Utah, 84124, United States
Investigator Site 102
Brno , 62500, Czechia
Investigator Site 104
Prague , 12008, Czechia
Investigator Site 103
Prague , 14021, Czechia
Investigator Site 605
Tbilisi , 0102, Georgia
Investigator Site 602
Tbilisi , 0159, Georgia
Investigator Site 604
Tbilisi , 0164, Georgia
Investigator Site 603
Tbilisi , 0179, Georgia
Investigator Site 201
Gottingen , 37075, Germany
Investigator Site 202
Heidelberg , 69120, Germany
Investigator Site 305
Warsaw , 02637, Poland
Investigator Site 409
Barnaul , 65609, Russian Federation
Investigator Site 407
Kemerovo , 65000, Russian Federation
Investigator Site 406
Moscow , 11102, Russian Federation
Investigator Site 402
Moscow , 11153, Russian Federation
Investigator Site 403
Moscow , 12930, Russian Federation
Investigator Site 404
St Petersburg , 19734, Russian Federation
Investigator Site 412
St Petersburg , 19820, Russian Federation
Investigator Site 405
St Petersburg , 19910, Russian Federation
Investigator Site 507
Dnipropetrovsk , 49023, Ukraine
Investigator Site 502
Kharkiv , 61018, Ukraine
Investigator Site 509
Kharkiv , 61176, Ukraine
Investigator Site 504
Kiev , 03680, Ukraine
Investigator Site 506
Kiev , 03680, Ukraine
Investigator Site 501
Kiev , 04114, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT00868439

Recruitment Status:

Completed

Sponsor:


Relypsa, Inc.

How clear is this clinincal trial information?

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