Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease

Prior treatment

• Use of strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone, carbamazepine)
• Use of systemic glucocorticoids for more than 7 days within 12 weeks prior to screening, or use of systemic glucocorticoids (intravenous/oral or intra - articular) or need for systemic immunosuppressive treatment within the past 14 days
• Participation in other interventional clinical trials within 3 months prior to screening

Other illness

• Chronic kidney disease diagnosed before Type 2 diabetes
• Acute urinary tract infection or conditions affecting urine tests
• Primary or secondary adrenal insufficiency
• Any organ system cancer within the past 5 years, whether treated or untreated

Lab values

• Serum potassium \>4.8 mmol/L
• HbA1c \>9%
• Use of medications with clear effects on urine protein and eGFR within 4 weeks (except kininogenase)
• ALT or AST \>2.5 × ULN, total bilirubin (TBIL) \>2 × ULN

Other

• Ineffective blood pressure control at screening (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg, average of three measurements in the supine position)
• Use of mineralocorticoid receptor antagonists
• Known pregnancy (positive pregnancy test), breastfeeding, recent plans for conception, or not using adequate contraception

• 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