EASi-KIDNEY - Studies of Heart & Kidney Protection with BI 690517 in combination with empagliflozin: A multicenter, international, randomized, double-blind, placebo-controlled clinical trial of the aldosterone synthase inhibitor BI 690517 in combination with empagliflozin in patients with chronic kidney disease - 1378-0006

Boehringer Ingelheim International GmbH0 个研究点目标入组 11,350 人开始时间: 2024年4月10日最近更新: 2024年8月21日

适应症

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•Age >= 18 years at Screening, Evidence of 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: (a) CKD-EPI eGFR =20 <45 mL/min/1.73m²; or (b) CKD-EPI eGFR =45 <90 mL/min/1.73m² with uACR =200 mg/g (or protein-to-creatinine ratio =300 mg/g).

•Blood potassium of >5.2 mmol/L at Screening visit, Blood ALT or AST >3x 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 RAS inhibitor (i.e. on dual therapy with two of an ACEi, ARB or direct renin inhibitor), Currently treated with an MRA (e.g. spironolactone, eplerenone, finerenone), Currently treated with systemic mineralocorticoid replacement therapy (e.g. fludrocortisone), Further exclusion criteria (see protocol)

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