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

Launched by BOEHRINGER INGELHEIM · Jul 29, 2024

Keywords

ClinConnect Summary

The EASi-KIDNEY™ trial is studying a new medicine called BI 690517 to see if it helps people with chronic kidney disease, especially when taken together with another medicine called empagliflozin. This study is open to adults who have chronic kidney disease and are at risk of it getting worse. You can participate whether or not you have type 2 diabetes, and you can still take other medicines that help protect your kidneys. To join, you need to have certain test results that show your kidney function is not normal but not too severe.

If you choose to participate, you will first take empagliflozin or a placebo (a pill that looks the same but has no medicine) for at least six weeks. Then, you will be randomly assigned to take either BI 690517 or another placebo daily, along with empagliflozin. Over the course of about three to four years, doctors will monitor your health through regular visits. They will check your kidney function, blood pressure, and overall health, looking for any signs that your kidney disease is worsening or if you experience heart problems. This trial is important because it aims to find ways to better protect kidney health and prevent serious complications.

Gender

ALL

Eligibility criteria

• Key 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:
• • 1. Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR ≥20 \<45 mL/min/1.73m²; or
• • 2. 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.