Patiromer to enable spironolactone use in the treatment of patients with resistant hypertension and chronic kidney disease: Rationale and design of the AMBER Study

Rajiv Agarwal, Patrick Rossignol, Dahlia Garza, Martha R. Mayo, Suzette Warren, Susan Arthur, Alain Romero, William B. White, Bryan Williams

Research output: Contribution to journalArticle

10 Scopus citations

Abstract

Background: While chronic kidney disease (CKD) is common in resistant hypertension (RHTN), prior studies -evaluating mineralocorticoid receptor antagonists excluded patients with reduced kidney function due to risk of hyperkalemia. AMBER (ClinicalTrials.gov identifier NCT03071263) will evaluate if the potassium-binding polymer patiromer used concomitantly with spironolactone in patients with RHTN and CKD prevents hyperkalemia and allows more persistent spironolactone use for hypertension management. Methods: Randomized, double-blind, placebo-controlled parallel group 12-week study of patiromer and spironolactone versus placebo and spironolactone in patients with uncontrolled RHTN and CKD. RHTN is defined as unattended systolic automated office blood pressure (AOBP) of -135-160 mm Hg during screening despite taking ≥3 antihypertensives, including a diuretic, and an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker -(unless not tolerated or contraindicated). The CKD inclusion criterion is an estimated glomerular filtration rate (eGFR) of 25 to ≤45 mL/min/1.73 m2. Screening serum potassium must be 4.3-5.1 mEq/L. The primary efficacy endpoint is the between-group difference (spironolactone plus patiromer versus spironolactone plus placebo) in the proportion of patients remaining on spironolactone at Week 12. Results: Baseline characteristics have been analyzed as of March 2018 for 146 (of a targeted 290) patients. Mean (SD) baseline age is 69.3 (10.9) years; 52.1% are male, 99.3% White, and 47.3% have diabetes. Mean (SD) baseline serum potassium is 4.68 (0.25) mEq/L, systolic AOBP is 144.3 (6.8) mm Hg, eGFR is 35.7 (7.7) mL/min/1.73 m2. Conclusion: AMBER will define the ability of patiromer to facilitate the use of spironolactone, an effective antihypertensive therapy for patients with RHTN and CKD.

Original languageEnglish (US)
Pages (from-to)172-180
Number of pages9
JournalAmerican journal of nephrology
Volume48
Issue number3
DOIs
StatePublished - Oct 1 2018

Keywords

  • Chronic kidney disease
  • Hyperkalemia
  • Patiromer
  • Resistant hypertension
  • Spironolactone

ASJC Scopus subject areas

  • Nephrology

Fingerprint Dive into the research topics of 'Patiromer to enable spironolactone use in the treatment of patients with resistant hypertension and chronic kidney disease: Rationale and design of the AMBER Study'. Together they form a unique fingerprint.

  • Cite this