Hyperkalemia in heart failure patients MedDRA version: 9.1 Level: LLT Classification code 10020647 Term: Hyperkalemia
Conditions
Interventions
Product Code: RLY5016
Pharmaceutical Form: Powder for oral suspension
Current Sponsor code: RLY5016
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical for
Sponsors
Relypsa, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 500 msec (Bazett’s correction formula) 11. Sustained systolic blood pressure > 170 or 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of RLY5016 on serum potassium in heart failure patients;Secondary Objective: To assess the safety and tolerability of RLY5016 in heart failure patients;Primary end point(s): Change from baseline in serum potassium | — |
Countries
Czech Republic, Germany
Outcome results
None listed