A trial to learn how well finerenone works and how safe it is in adult participants with non-diabetic chronic kidney disease
- Conditions
- on-diabetic chronic kidney diseaseMedDRA version: 23.1Level: PTClassification code: 10064848Term: Chronic kidney disease Class: 100000004857Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-506897-11-00
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1584
A clinical diagnosis of chronic kidney disease and: • Urine albumin/creatinine ratio (UACR) of = 200 but = 3500 mg/g and estimated glomerular filtration rate (eGFR) =25 but <90 mL/min/1.73m^2 at screening, and • Documentation of albuminuria/proteinuria in the participant's medical records at least 3 months prior to screening., Stable and maximum tolerated labeled dose of an Angiotensin converting enzyme inhibitor (ACEI) or Angiotensin receptor blocker(ARB) for at least 4 weeks prior to screening, K+ = 4.8 mmol/L at screening
Established diagnosis of Type 1 or 2 Diabetes mellitus, or HbA1c = 6.5% (48 mmol/mol), Autosomal dominant or autosomal recessive polycystic kidney disease, Lupus nephritis or anti-neutrophilic cytoplasmic autoantibody (ANCA) - associated vasculitis or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening, Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonist (MRA)s
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