Abstract / Summary
Diabetic nephropathy is one of the most clinically significant microvascular complications of type 2 diabetes mellitus (T2DM) and remains a major cause of progressive chronic kidney disease (CKD), cardiovascular complications, and end-stage kidney disease. Despite optimization of glycemic control, blood pressure, and blockade of the renin–angiotensin system, a substantial proportion of patients retain considerable residual renal and cardiovascular risk. Materials and Methods. A prospective, randomized, comparative, open-label, parallel-group clinical study is planned in 120 patients with T2DM, diabetic nephropathy, persistent albuminuria, and an estimated glomerular filtration rate (eGFR) of 25–75 mL/min/1.73 m² receiving maximally tolerated renin–angiotensin system blockade. Participants will be randomized into three groups: finerenone monotherapy (n=40), empagliflozin monotherapy (n=40), and combined finerenone plus empagliflozin therapy (n=40). In each treatment arm, 20 patients will have CKD stage 2 and 20 patients CKD stage 3. and fibrotic markers, and treatment safety. Follow-up is planned for 12–18 months. Conclusion. The combined administration of finerenone and empagliflozin is pathogenetically justified because it simultaneously targets glomerular hyperfiltration, neurohormonal activation, inflammation, and fibrosis. The proposed approach may potentially achieve more effective stabilization of renal function and reduction of cardiorenal risk than either therapy used alone.