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



Status:Completed
Conditions:High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:12/14/2018
Start Date:February 13, 2017
End Date:November 27, 2018

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A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of Patiromer for the Enablement of Spironolactone Use for Blood Pressure Control in Patients With Resistant Hypertension and Chronic Kidney Disease

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).

Approximately 290 eligible participants with [chronic kidney disease (CKD) on stable doses of
medication] will be randomly assigned to receive a patiromer or placebo starting dose of two
packets a day, once a day.

All eligible participants will undergo a screening/run-in period (up to 4 weeks) to determine
eligibility for study entry. Eligible participants will be randomized and treated for 12
weeks (Treatment Period) and followed for 2 weeks after completing the patiromer or placebo
treatment. There are 8 planned clinic visits during the Treatment Period and one planned
visit two weeks after the last dose of patiromer or placebo (Follow-up Period).

The dose of patiromer or placebo may be increased or decreased (titrated) based on
participants' individual potassium response.

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
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