Resistant Hypertension and Chronic Kidney Disease MedDRA version: 20.0 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disorders
Conditions
Sponsors
Relypsa, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible subjects must meet all the following criteria: 1. Provide written informed consent prior to participation in the study 2. Age = 18 years 3. Taking at least three antihypertensive medications, one of which is a diuretic, for at least 28 days at a stable dose. ACE inhibitors or ARBs should be included among these three antihypertensive medications, unless previously not tolerated or contraindicated. 4. Uncontrolled hypertension as documented by AOBP SBP 135 to 160 mmHg at each Screening Visit; however, AOBP SBP may be =65 years) yes F.1.3.1 Number of subjects for this age range 116
Exclusion criteria
Exclusion criteria: Subjects must not meet any of the following criteria: 1. History of untreated secondary causes of hypertension (other than CKD) including but not limited to Cushing’s syndrome, primary hyperaldosteronism, renal vascular stenosis, or coarctation of the aorta 2. Inability to measure BP (e.g., the largest sized arm BP cuff is inadequate given the circumference of the subject’s arm) 3. Noncompliance with antihypertensive medications, in the investigator’s judgment 4. Change in renal function requiring hospitalization or dialysis within 3 months prior to screening 5. Renal transplant or anticipated need for renal transplantation during planned study participation 6. History of malignancy within the previous 12 months except for cured non-melanocytic skin cancer 7. Recent cardiovascular event (within the last 3 months): myocardial infarction, unstable angina, hospitalization for heart failure, revascularization, or stroke (or transient ischemic attack) 8. Clinically significant ventricular arrhythmia 9. Atrial fibrillation with HR > 100 bpm 10. Previous use of patiromer in a clinical study 11. Any current use of spironolactone or other mineralocorticoid antagonists (e.g., eplerenone) 12. Hypersensitivity to patiromer, spironolactone, or any of their components 13. Use of any of the following permitted potassium-altering chronic medications if doses have not been stable for at least 28 days prior to screening or if doses are anticipated to change during study participation: bronchodilators, theophylline, heparin, and canagiflozin 14. Use of the following prohibited medications within 7 days prior to Screening: calcium acetate or calcium carbonate supplements (unless for occasional antacid use, at the discretion of the Investigator), digoxin, direct renin inhibitors (e.g., aliskiren), lanthanum carbonate, lithium, sevelamer, quinidine, sodium polystyrene sulfonate or calcium polystyrene sulfonate, colesevelam, colestipol, cholestyramine, drospirenone, potassium supplements, bicarbonate or baking soda (unless for occasional antacid use, at the discretion of the Investigator), triamterene, amiloride, trimethoprim, tacrolimus, cyclosporine, systemic glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (with the exception of low dose aspirin), sympathomimetics 15. Use of any investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening 16. History of bowel obstruction, swallowing disorders, clinically significant gastroparesis, severe gastrointestinal disorders or major gastrointestinal surgery (e.g., large bowel resection) 17. Inability to take the study medications or comply with the protocol, in the opinion of the Investigator 18. History of alcohol or drug abuse within 1 year of screening 19. Any medical condition, uncontrolled systemic disease, or serious intercurrent illness that would significantly decrease study compliance or jeopardize the safety of the subject or affect the validity of the trial results, in the opinion of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if patiromer treatment of CKD subjects receiving spironolactone for the treatment of resistant hypertension will result in: • More persistent use of spironolactone through prevention of hyperkalemia • Improved blood pressure control through more persistent use of spironolactone ;Secondary Objective: Not applicable;Primary end point(s): The proportion of subjects remaining on spironolactone at Week 12 will be compared between treatment groups (spironolactone/patiromer vs. spironolactone/placebo) using the Cochran-Mantel-Haenszel test, stratified by baseline serum potassium category (K+ 4.3 – < 4.7 mEq/L or 4.7 – 5.1 mEq/L).;Timepoint(s) of evaluation of this end point: Baseline to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): AOBP SBP change from baseline to Week 12 or last available assessment prior to addition of any new BP medications or changes to any baseline BP medications will be analyzed using analysis of covariance (ANCOVA) methods.;Timepoint(s) of evaluation of this end point: Baseline to week 12 or last available assessment before any new BP medication | — |
Countries
Bulgaria, Croatia, France, Georgia, Germany, Hungary, South Africa, Ukraine, United Kingdom, United States
Contacts
Public ContactMaia Abdushelishvili
Worldwide Clinical Trials Limited
Outcome results
None listed