A study to learn how well the treatment combination of finerenone and empagliflozin works and how safe it is compared to each treatment alone in adult participants with long-term kidney disease (chronic kidney disease) and type 2 diabetes.
- Conditions
- Chronic kidney disease in type 2 diabetes mellitusMedDRA version: 21.1Level: LLTClassification code: 10045250Term: Type II diabetes mellitus with renal manifestations Class: 10038359Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- CTIS2023-506981-30-00
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 807
Participant with a clinical diagnosis of chronic kidney disease (CKD) and the following: a. In Part A: eGFR 40-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnosis of CKD. b. In Part B: eGFR 30-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using CKD-EPI formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnostic of CKD. c. 100 =UACR <5000 mg/g at screening visit (mean value from 3 morning void samples) and documentation of albuminuria/proteinuria (quantitative or semi-quantitative measurement) in the participant's medical records at least 3 months prior to screening, Participant with type 2 diabetes (T2D) as defined by the American Diabetes Association (ADA 2021), with glycated hemoglobin (HbA1c) at screening <11%., Participant treated with the clinically maximum tolerated dose, as per investigator judgment, of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), but not both, for more than 1 month at screening visit.
Participants with type 1 diabetes (T1D)., Participant with hepatic insufficiency classified as Child-Pugh C., Participant with blood pressure at Day 1 visit (Visit 2) higher than 160 SBP or 100 DBP or SBP lower than 90 mmHg., Participant currently treated with a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or SGLT-1/2i or who received a SGLT2i or SGLT-1/2i which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment., Participant treated with another mineralocorticoid receptor antagonist (MRA) (e.g., eplerenone, esaxerenone, spironolactone, canrenone), a renin inhibitor, potassium supplements, a potassium sparing diuretic (e.g., amiloride, triamterene), a potassium binder agent, or angiotensin receptor-neprilysin inhibitor (ARNI) which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment., Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit., Participant with serum/plasma potassium (K+) above 4.8 mmol/L at screening (central laboratory value).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that combination therapy using finerenone and empagliflozin is superior in reducing UACR (Urinary albumin to-creatinine ratio) than either empagliflozin or finerenone alone.;Secondary Objective: To further investigate the efficacy of combination therapy using finerenone and empagliflozin versus either finerenone or empagliflozin alone, To evaluate the safety of combination therapy using finerenone and empagliflozin versus either finerenone or empagliflozin alone;Primary end point(s): Mean ratio of change from baseline to Day 180 in Urinary albumin to creatinine ratio (UACR) for the combination therapy group, to empagliflozin alone., Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone alone.
- Secondary Outcome Measures
Name Time Method