Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 * Willing to sign a written informed consent and comply with the study protocol Exclusion Criteria: * 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% * Acute urinary tract infection or conditions affecting urine tests * Primary or secondary adrenal insufficiency * Use of mineralocorticoid receptor antagonists * Use of medications with clear effects on urine protein and eGFR within 4 weeks (except kininogenase) * Use of strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nef