EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)

NCT06531824Sponsor: Boehringer IngelheimLouise MoistLouise Moist

Actively Recruiting

View on ClinicalTrials.gov ↗

About This Study

This multicenter, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of the aldosterone synthase inhibitor BI 690517 in combination with empagliflozin in adults with CKD at risk of progression. Participants, with or without type 2 diabetes, are stabilized on an ACEi or ARB and empagliflozin before randomization to either BI 690517 or placebo. The primary objective is to assess the time to first occurrence of a composite clinical endpoint including worsening kidney disease, heart failure hospitalization, or cardiovascular death. Investigators monitor longitudinal changes in eGFR, UACR, and blood pressure over a follow-up period of approximately 3 to 4 years.

Who Can Participate?

✓ Inclusion Criteria

  • •Evidence of chronic kidney disease (CKD) at risk of kidney disease progression is defined on the basis of local laboratory results recorded at least 3 months before and at the time of the Screening visit, and requires: Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR ≥20 <45 mL/min/1.73m²; or CKD-EPI eGFR ≥45 <90 mL/min/1.73m² with urine albumin-to-creatinine ratio (uACR) ≥200 mg/g (or protein-to-creatinine ratio ≥300 mg/g).
  • •Neither requires an Aldosterone Synthase inhibitor (ASi) or Mineralocorticoid Receptor Antagonist (MRA), nor that such treatment is definitely inappropriate. Key

✗ Exclusion Criteria

  • •Blood potassium of >5.2 mmol/L at screening visit
  • •Blood Alanine Transaminase (ALT) or Aspartate Transaminase (AST) >3x Upper Limit of Normal (ULN) at Screening visit
  • •Known liver cirrhosis
  • •On dialysis, functioning kidney transplant, or scheduled living donor transplant
  • •Treated with new immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days
  • •Receiving more than one Renin-Angiotensin System (RAS) inhibitor (i.e. on dual therapy with two of an Angiotensin-Converting Enzyme inhibitor (ACEi), Angiotensin Receptor Blocker (ARB) or direct renin inhibitor)
  • •Currently treated with an Mineralocorticoid Receptor Antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone)
  • •Currently treated with systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply.