Evaluation of Patiromer in Heart Failure Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperkalemia, Heart Failure

In brief

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.

Key facts

Study ID

NCT00868439

Run by

Relypsa, Inc.

People needed

120

Starts

2009-04-01

Expected to finish

2009-12-01

Last updated by the study team

2021-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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