Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease

• Status: Completed
• Trial end date: 2018-11-27
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if patiromer treatment in chronic kidney disease (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will result in more persistent use of spironolactone through prevention of hyperkalemia and lead to improved blood pressure control compared with treatment with spironolactone alone (placebo).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Relypsa, Inc.
• Treatments: Spironolactone

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Taking at least three medications for blood pressure (one a diuretic)

• Uncontrolled high blood pressure

• Abnormal kidney function (with-eGFR, a measure of kidney function, of 25 - ≤ 45 mL/min/1.73m2

• Normal Blood serum Potassium in a specific range (4.3 - 5.1 mEq/L)

Exclusion Criteria:

• History of untreated known causes of high blood pressure, excluding kidney disease (not CKD)

• Inability to measure BP

• Not taking high blood pressure medications as prescribed medications

• Recent change in renal function (in the past 3 months) which has required hospitalization or dialysis

• Renal transplant

• History of cancer within past 12 months

• Recent cardiovascular event with last 3 months

• Clinically significant abnormalities of heart rhythm (ventricular arrhythmia or atrial fibrillation with uncontrolled heart rate)

• Inability to take study medication

• Alcoholism