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

Relypsa

Status and phase: Completed; Phase 2

Conditions: Hyperkalemia; Resistant Hypertension

Treatments: Drug: Spironolactone; Drug: Placebo; Drug: Patiromer

Study type: Interventional

Funder types: Industry

Identifiers

NCT03071263

RLY5016-207

2016-002657-38 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 295 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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295 participants in 2 patient groups

Group 1 - Patiromer

Experimental group

Description:

spironolactone + blinded patiromer

Treatment:

Drug: Patiromer

Drug: Spironolactone

Group 2 - Placebo

Experimental group

Description:

spironolactone + blinded placebo

Treatment:

Drug: Placebo

Drug: Spironolactone