EASi-KIDNEY - Studies of Heart & Kidney Protection with BI 690517 in combination with empagliflozi
- Conditions
- Chronic kidney diseaseMedDRA version: 23.1Level: PTClassification code: 10064848Term: Chronic kidney disease Class: 100000004857Therapeutic area: Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]
- Registration Number
- CTIS2024-511025-63-00
- Lead Sponsor
- Boehringer Ingelheim International GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 11350
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method