Finerenone plus empagliflozin as new potential combination in patients with type 2 diabetes and chronic kidney disease

Presented by

Prof. Johannes Mann, Friedrich Alexander University, Germany

Conference

ERA 2025

Trial

Phase 2, CONFIDENCE

The combination of finerenone with the SGLT2 inhibitor empagliflozin, compared with either agent alone, improved albuminuria in patients with type 2 diabetes and concomitant chronic kidney disease, with a slight increase in symptomatic hypotension, according to data from the CONFIDENCE trial.

CONFIDENCE (NCT05254002) is a randomised, double-blind, phase 2 trial assessing the combination of finerenone with empagliflozin in patients with type 2 diabetes and chronic kidney disease [1]. Patients were eligible if they had an eGFR between 30–90 mL/min/1.73 m², urinary albumin-creatinine ratio (UACR) between 100–<5,000 mg/g, and Hb1Ac <11%. A total of 800 participants were randomised 1:1:1 to finerenone plus empagliflozin, finerenone alone, or empagliflozin alone, and the primary endpoint was relative change in UACR from baseline to day 180.

Albuminuria was reduced as early as day 14 (-30%) with the combination treatment, reaching a 52% reduction at day 180, where the combination showed a 29% greater reduction versus finerenone and a 32% greater reduction versus empagliflozin. Furthermore, 70% of patients who received the combination had a reduction of more than 30% in UACR by day 180, compared with 52% of patients with finerenone and 52% of patients with empagliflozin. Hyperkalaemia was less common with the combination (15.3%) than with finerenone alone (18.6%), but more common than with empagliflozin alone (9.7%). Finally, rates of symptomatic hypotension with the combination were low at 1.1%, and not reported at all with the individual therapies.

Prof. Johannes Mann (Friedrich Alexander University, Germany), 1 of the 4 study presenters, concluded that “the evidence demonstrates the combined benefits of multiple pillars of therapy, and potentially we suggest that greater benefits can be obtained the earlier treatment is instituted through intensive treatments. The findings clearly show that the combination of finerenone and an SGLT2 inhibitor simultaneously provide benefit but no appreciable risks.”

Agarwal J, et al. The CONFIDENCE trial: Efficacy/Safety of combining finerenone with empagliflozin in people with chronic kidney disease and type 2 diabetes. 62nd ERA Congress, 4–7 June 2025, Vienna, Austria.

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