Acute eGFR Changes With Finerenone Examined in a Prespecified Analysis of FINE-ONE

The nonsteroidal mineralocorticoid receptor antagonist finerenone reduces urine albumin-to-creatinine ratio (UACR) in people with type 1 diabetes (T1D) and chronic kidney disease (CKD). This prespecified analysis evaluated acute changes in estimated glomerular filtration rate (eGFR) with finerenone and their impact on safety.

Adults with T1D and CKD (n = 242; eGFR ≥ 25-< 90 ml/min per 1.73 m²; UACR ≥ 200 to < 5000 mg/g) receiving stable renin-angiotensin system (RAS) inhibition were randomized 1:1 to finerenone or placebo. The primary outcome was acute change in eGFR (from baseline to month 1), termed "eGFR dip." Reversibility of eGFR change was assessed from end of the treatment (month 6) to follow-up (month 7). Change in eGFR was assessed across eGFR dip subgroups (eGFR > 0 to ≤ 10% decline, > 10% decline, and ≥ 0% increase) and prespecified characteristics (baseline eGFR, UACR, history of cardiovascular disease [CVD], and diuretic use).

Mean acute eGFR decline at month 1 was greater with finerenone (-2.78 ml/min per 1.73 m² [95% confidence interval [CI], -4.15 to -1.40]) versus placebo (-0.78 ml/min per 1.73 m²; [95% CI, -2.22 to 0.66]); treatment difference was -1.99 ml/min per 1.73 m² (95% CI, -3.97 to -0.01 [P = 0.049]). Placebo-corrected eGFR increased during the washout period across the groups. Acute eGFR changes did not differ according to prespecified characteristics. The incidence of treatment-emergent adverse events (TEAEs) was comparable across eGFR dip subgroups in both the treatment groups. Greater declines in eGFR were associated with greater reductions in UACR at month 3.

In people with T1D and CKD, finerenone induced an acute eGFR dip that was well tolerated without unexpected safety signals.