About this trial
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of finerenone, a nonsteroidal mineralocorticoid receptor antagonist, for the early regression of albuminuria in adults with type 2 diabetes mellitus and chronic kidney disease (eGFR \>= 30 mL/min/1.73 m\^2 and UACR 30-2000 mg/g) who are already receiving a maximum tolerated dose of an ACE inhibitor or ARB. A total of 148 participants are randomized 1:1, stratified by baseline UACR (\<300 vs \>=300 mg/g), to oral finerenone (10 or 20 mg once daily, titrated by serum potassium and eGFR) or matching placebo, on top of standard background therapy, for 180 days, followed by a 30-day off-treatment follow-up. Albuminuria regression is defined as both an improvement in Kidney Disease: Improving Global Outcomes albuminuria category, from A3 to A2 or A1, or from A2 to A1, and a more than 30% reduction in urinary albumin-to-creatinine ratio from baseline. The outcome will be reported as the percentage of participants meeting this definition at Day 180.
Eligibility criteria
Qualifiers
1. Age >= 18 years at the time of signing informed consent, male or female.
2. Type 2 diabetes mellitus.
3. Chronic kidney disease meeting BOTH of the following: eGFR (CKD-EPI) >= 30 mL/min/1.73 m², and UACR 30-2000 mg/g (mean of 3 measurements).
4. Serum potassium <= 5.0 mmol/L.
Disqualifiers
1. Type 1 diabetes, other specific types of diabetes, or gestational diabetes.
2. HbA1c >= 8.0%.
3. On renal replacement therapy.
4. Acute kidney injury within 180 days before the screening visit.
Trial design
Treatments tested in this trial
- Finerenone (BAY 94-8862)
- Placebo