Efficacy and safety of finerenone in Asian patients with type 2 diabetes and chronic kidney disease: A FIDELITY analysis by baseline kidney function.

AIMS: Define the effect of finerenone on kidney function within the overall FIDELITY Asian subpopulation.

METHODS

This FIDELITY pooled subanalysis assessed the following outcomes in the Asian subpopulation: chronic estimated glomerular filtration rate (eGFR) slope, urine albumin-to-creatinine ratio (UACR) from baseline to month 4, time to UACR regression, and safety.

RESULTS

In total, 2858 (22.0 %) participants included in FIDELITY were Asian. Chronic eGFR slope was reduced with finerenone compared with placebo in the Asian subpopulation; least-squares mean between-group difference was 1.08 mL/min/1.73 m2 (95 % confidence interval 0.53-1.63; p = 0.0002). Greater reductions in chronic eGFR slope were also observed for finerenone compared with placebo when analyzed according to baseline UACR. Finerenone treatment reduced UACR from baseline to month 4 by 34 %. This treatment effect was seen regardless of baseline eGFR, systolic blood pressure, glycated hemoglobin, body mass index, sodium-glucose co-transporter-2 inhibitor use, and glucagon-like peptide-1 receptor agonist use. Regression from high to normal albuminuria was seen in 39.5 % of all Asian participants treated with finerenone versus 14.8 % receiving placebo. Treatment-emergent adverse events were similar between finerenone and placebo, and hyperkalemia was manageable.

CONCLUSION

Finerenone slows eGFR decline and lowers UACR in Asian participants with chronic kidney disease and type 2 diabetes.

TRIAL REGISTRATION NUMBER: FIDELIO-DKD (NCT02540993); FIGARO-DKD (NCT02545049).