Heart failure with Chronic kidney disease MedDRA version: 12.1 Level: LLT Classification code 10008908 Term: Chronic heart failure MedDRA version: 12.1 Level: LLT Classification code 10064848 Term: Chronic kidney disease
Conditions
Interventions
Trade Name: N/A
Product Name: RLY5016
Product Code: RLY5016
Pharmaceutical Form: Powder for oral suspension
Current Sponsor code: RLY5016
Concentration unit: g gram(s)
Concentration type: equal
Concen
Sponsors
Relypsa, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chronic heart failure clinically indicated to receive spironolactone therapy 2. Age 18 years or older 3. Local lab serum potassium values of 4.3 – 5.1 mEq/L at screening and baseline 4. Chronic kidney disease (estimated 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 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 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 180 or 3 times upper limit of normal 12. Loop and thiazide diuretics 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 medications 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. Patients who have taken investigational product in this study, or a previous RLY5016 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 patient or affect the validity of the trial results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the feasibility of individualized titration of RLY5016 according to serum potassium.;Secondary Objective: To assess the effects of RLY5016 on serum potassium in heart failure patients with chronic kidney disease To assess the safety and tolerability of RLY5016 in heart failure patients with chronic kidney disease;Primary end point(s): Proportion of patients with serum potassium in the normal range of 3.5 – 5.5 mEq/L at the end of the study. | — |
Countries
Slovenia
Outcome results
None listed