A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Study to Evaluate the Effects of RLY5016 in Heart Failure Patients - PEARL-HF

Conditions: Hyperkalemia in heart failure patients
MedDRA version: 9.1Level: LLTClassification code 10020647Term: Hyperkalemia

Registration Number: EUCTR2009-009983-29-DE

Lead Sponsor: Relypsa, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 270

Inclusion Criteria

1. Patients with chronic heart failure clinically indicated to receive spironolactone therapy, aged 18 years or older with serum potassium levels of 4.3 - 5.1 mEq/L at screening, AND:
a) Chronic kidney disease (estimated glomerular filtration rate (GFR) <60 mL/min/1.73 m2) on one or more heart failure therapies [angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blockers (ARB), beta blocker (BB)] OR
b) Documented history of hyperkalemia, within the last 6 months prior to study entry, which led to the discontinuation of (AA), ACEI, ARB, or BB therapy
2. 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
3. Male patients 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
4. Patients who have provided their written informed consent prior to participation in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery
2. Uncorrected hemodynamically significant primary 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 study entry 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 3 months prior to study entry: unstable angina as judged by the Investigator, unresolved acute coronary syndrome, transient ischemic attack or stroke
6. Current dialysis patient, 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
9. History of alcoholism or drug/chemical abuse within 2 years prior to study entry
10. QTcB interval > 500 msec (Bazett’s correction formula)
11. Sustained systolic blood pressure > 170 or < 90 mmHg
12. Liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST)) > 3 times upper limit of normal
13. Use of oral cardiac medications (including loop and thiazide diuretics) that have not been stable for at least 21 days prior to study entry and are not anticipated to remain stable during study participation
14. Use of any IV medications within 21 days prior to study entry, or their anticipated need during study participation.
15. Current use of polymer-based drugs (e.g. Renagel, Kayexalate, Welchol, Colestid), other phosphate binders or potassium binders, calcium supplements, antiacids (e.g. TUMS, Maalox) or their anticipated need during study participation
16. Use of aldosterone antagonist in the last 30 days prior to study entry, unless was discontinued due to hyperkalemia
17. Use of potassium sparing medication and/or potassium supplements in the last 30 days prior to study entry
18. Use of any investigational medication, 30 days or 5 half-lives whichever is longer, prior to study entry
19. Patients who have taken investigational product in this study, or a previous RLY5016 study
20. Inability to consume the study medication, or, in the opinion of the Investigator, inability to comply with the protocol
21. 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 study entry, that would significantly decrease study compliance or jeopardize the safety of the patient or affect the validity of the trial results