Abstract: INFO24

Patiromer to Enable Spironolactone Use in the Treatment of Patients with Resistant Hypertension and Chronic Kidney Disease: Rationale and Design of the AMBER Study

Session Information

  • Informational Posters
    October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category:

Authors

  • Agarwal, Rajiv, Indiana University School of Medicine, Indianapolis, Indiana, United States
  • Rossignol, Patrick, Clinical Investigation Center-INSERM-CHU of Nancy, VANDOEUVRE LES NANCY, France
  • Garza, Dahlia, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • Mayo, Martha, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • Warren, Suzette, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • Arthur, Susan, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • Romero, Alain, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • White, William B., University of Connecticut Health Center, Farmington, Connecticut, United States
  • Williams, Bryan, University College London, London, United Kingdom
Description

Clinical trials like PATHWAY-2 have demonstrated that spironolactone (SPIRO) is an effective agent in the treatment of resistant hypertension (RHTN). However, prior studies evaluating mineralocorticoid receptor antagonists have excluded patients (pts) with reduced kidney function due to concerns related to hyperkalemia. Chronic kidney disease (CKD) is a common comorbidity in RHTN. AMBER (NCT03071263) will evaluate if the potassium (K+)-binding polymer patiromer used concomitantly with SPIRO in pts with RHTN and CKD prevents hyperkalemia and allows more persistent use of SPIRO for hypertension management. This is a randomized, double-blind, placebo-controlled parallel group 12-week study of patiromer and SPIRO vs placebo and SPIRO in pts with uncontrolled RHTN and CKD (Figure). For eligibility, RHTN is defined as unattended systolic automated office blood pressure (AOBP) of 135–160 mmHg during screening despite taking ≥3 antihypertensives, including a diuretic, and an ACE inhibitor or an ARB (unless not tolerated or contraindicated). The CKD inclusion criterion is an eGFR of 25 to ≤45 ml/min/1.73m2. Screening serum K+ must be 4.3–5.1 mEq/L. Randomization is stratified by baseline serum K+ and presence/absence of diabetes mellitus. The primary efficacy endpoint is the between-group difference (SPIRO plus patiromer versus SPIRO plus placebo) in the proportion of pts remaining on SPIRO at week 12. A key secondary end-point is a comparison in the reduction in systolic blood pressure during 12 weeks of treatment. In summary, AMBER is an ongoing trial being conducted in multiple centers in the USA, Europe, and South Africa to define the ability of patiromer to facilitate the use of SPIRO, an effective antihypertensive therapy for pts with RHTN and CKD. Recruitment is ongoing; results are expected by 2019.

Funding

  • Relypsa, Inc., a Vifor Pharma Group Company