Key result
Planned RCT tests whether finerenone plus empagliflozin outperforms monotherapy for cardiorenal protection.
Why the study?
Despite optimized glycemic control, blood pressure, and renin–angiotensin system blockade, many patients with diabetic nephropathy retain significant residual renal and cardiovascular risk.
Does combined finerenone and empagliflozin improve fibrotic markers and safety compared to either monotherapy in patients with T2DM and diabetic nephropathy?
RCT (n=120)
Open-label
randomized
Does combined finerenone and empagliflozin improve fibrotic markers and safety compared to either monotherapy in patients with T2DM and diabetic nephropathy?
This paper outlines the rationale and design for a planned randomized trial evaluating the combination of finerenone and empagliflozin to reduce cardiorenal risk in patients with diabetic nephropathy.
Residual cardiorenal risk persists despite maximal RAS blockade in diabetic nephropathy; leaves open need for novel adjunctive therapies in prospective trials.
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.
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Kamola et al. (2026) conducted an RCT in Diabetic nephropathy and impaired renal function in type 2 diabetes mellitus (n=120). Combined finerenone and empagliflozin vs. Finerenone monotherapy or empagliflozin monotherapy was evaluated on Fibrotic markers and treatment safety. A planned randomized trial will evaluate whether combined finerenone and empagliflozin more effectively stabilizes renal function and reduces cardiorenal risk than either monotherapy.
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