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

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

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, nefazodone, carbamazepine)
* ALT or AST \>2.5 × ULN, total bilirubin (TBIL) \>2 × ULN
* 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
* Any organ system cancer within the past 5 years, whether treated or untreated
* Known pregnancy (positive pregnancy test), breastfeeding, recent plans for conception, or not using adequate contraception
* Participation in other interventional clinical trials within 3 months prior to screening

Conditions4

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