Evaluation of Patiromer Titration in Heart Failure Patients With Chronic Kidney Disease
Condition: Heart Failure
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Heart Failure
Intervention: patiromer; spironolactone
Intervention description: Active investigational drug
Intervention MeSH terms: Spironolactone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HF; Heart failure; hyperkalemia; chronic kidney disease; prevention of hyperkalemia in heart failure participants

Summary:

      The purpose of this study was to evaluate the feasibility of individualized titration of
      patiromer according to serum potassium. This study also assessed the safety and tolerability
      of patiromer and the effects of patiromer on serum potassium in heart failure (HF)
      participants with chronic kidney disease (CKD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Chronic HF clinically indicated to receive spironolactone therapy

          2. Age 18 years or older

          3. Local laboratory serum potassium values of 4.3 - 5.1 mEq/L at screening and baseline

          4. CKD (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73m2 at screening based
             on central lab creatinine measurement)

          5. On at least one of the following HF therapies: ACEI, ARB, or BB

          6. 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

          7. 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

          8. Provide their written informed consent prior to participation in the study

        Exclusion Criteria:

          1. History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders
             or major gastrointestinal surgery

          2. Uncorrected primary severe valvular disease, known obstructive or restrictive
             cardiomyopathy, uncontrolled or hemodynamically unstable arrhythmia

          3. 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

          4. Heart transplant recipient, or anticipated need for transplant during study
             participation

          5. Any of the following events having occurred within 2 months prior to baseline:
             unstable angina as judged by the Investigator, unresolved acute coronary syndrome,
             transient ischemic attack or stroke

          6. Current dialysis participant, or anticipated need for dialysis during study
             participation

          7. Prior kidney transplant, or anticipated need for transplant during study participation

          8. Metastatic, late-stage or end-stage cancer with < 12 months life expectancy or at risk
             for tumor lysis syndrome

          9. History of alcoholism or drug/chemical abuse within 1 year

         10. Sustained systolic blood pressure > 180 or < 90 mmHg

         11. Liver enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST)] > 3
             times upper limit of normal

         12. Loop and thiazide diuretics that have not been stable for at least 21 days prior to
             baseline or not anticipated to remain stable during study participation

         13. Use of any intravenous cardiac medications within 21 days prior to baseline, or their
             anticipated need during study participation

         14. Current use of polymer-based drugs (e.g., sevelamer, sodium polystyrene sulfonate,
             colesevelam, colestipol), phosphate binders (e.g., lanthanum carbonate), or other
             potassium binders, or their anticipated need during study participation

         15. Use of potassium sparing medication including aldosterone antagonists or potassium
             supplements in the last 21 days prior to baseline

         16. Use of any investigational medication within 30 days or 5 half-lives, whichever is
             longer, prior to baseline

         17. Participants who have taken investigational product in this study, or a previous
             patiromer study

         18. Inability to consume the study medication, or, in the opinion of the Investigator,
             inability to comply with the protocol

         19. 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