Last updated 27 days ago

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

11000 patients around the world
Available in United States, Argentina
Boehringer Ingelheim
1Research sites
11000Patients around the world

Requirements for the patient

From 18 Years
All Gender

Medical requirements

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.
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.
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).

Sites

Instituto de Investigaciones Clínicas (IIC) - Rosario
Paraguay 160, S2000CVD Rosario, Santa Fe, Argentina
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