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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Hyperkalemia, Resistant Hypertension

Intervention / Treatment
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* Drug: Patiromer
* Drug: Placebo
* Drug: Spironolactone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - Patiromer<br>spironolactone + blinded patiromer | Drug: Patiromer<br>* 2 packets/day starting dose, administered orally<br>* Other names: Patiromer for Oral Suspension;Drug: Spironolactone<br>* 25 mg tablet/day starting dose, administered orally<br>|
| Experimental: Group 2 - Placebo<br>spironolactone + blinded placebo | Drug: Placebo<br>* 2 packets/day starting dose, administered orally<br>Drug: Spironolactone<br>* 25 mg tablet/day starting dose, administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Remaining on Spironolactone at Week 12 | The proportion of subjects remaining on spironolactone at Week 12 will be compared between treatment groups (spironolactone/patiromer versus spironolactone/placebo). Subjects who discontinued from the study early or discontinued study spironolactone prior to Week 12, for any reason, were considered as not having remained on spironolactone until Week 12. | At week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AOBP SBP From Baseline to Week 12 or Last Available AOBP SBP Prior to Addition of Any New BP Medications or Increase From Any Baseline BP Medications | AOBP: Automated Office Blood Pressure SBP: Systolic Blood Pressure BP: Blood Pressure | From baseline to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment of Hyperkalemia, Hyperkalemia, Potassium, Chronic Kidney Disease, Hypertension, Resistant Hypertension, Spironolactone