Research Objectives To evaluate the impact of finerenone on renal function, diabetic complications, and safety in patients with Type 2 diabetes and chronic kidney disease.
Study Design Type: Prospective, single-arm, multicenter clinical trial. Sample Size: 300 patients. Intervention: Finerenone added to existing treatment regimen (10-20 mg once daily, dose adjusted based on eGFR), for 48 weeks.
Data Collection Time Points: Baseline, 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Primary Endpoint: Change in urine albumin-to-creatinine ratio (UACR). Secondary Endpoints: Changes in eGFR, 24-hour urine protein, serum uric acid, retinopathy markers, pulse wave velocity (PWV), ankle-brachial index (ABI), etc.
Safety Endpoints: Changes in serum potassium, sodium, and blood pressure.
Diagnosed with Type 2 diabetes according to the 1999 WHO criteria
Aged ≥18 years
UACR ≥30 mg/g and eGFR ≥30 ml/min/1.73 m² sustained for over 3 months
Stable ARB/ACEI treatment for ≥4 weeks prior to enrollment
Chronic kidney disease diagnosed before Type 2 diabetes
Serum potassium >4.8 mmol/L
Ineffective blood pressure control at screening (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg, average of three measurements in the supine position)
HbA1c >9%