FINE-ONE randomised 242 adults with type 1 diabetes and chronic kidney disease, UACR 200 to <5,000 mg/g and eGFR 25 to <90 mL/min/1.73 m2, to finerenone or placebo. This exploratory analysis asks a question clinicians raise immediately: does the benefit depend on how well the diabetes itself is controlled?
It does not. Median UACR fell from 574.6 to 373.5 mg/g with finerenone against 506.4 to 475.6 mg/g with placebo, a placebo-corrected change of -25% (95% CI -35% to -13%, P = 0.0001). Across HbA1c tertiles (<7.1%, 7.1-8.1%, >8.1%) the placebo-corrected reductions were -17%, -18% and -37%, with P for interaction 0.41. Splitting by diabetes duration gave the same answer, P for interaction 0.70, in a cohort whose mean duration was 32 years.
HbA1c itself was unchanged (between-group difference +0.04%, P = 0.74), which is the point: this is a haemodynamic and anti-fibrotic effect on the kidney, not a glycaemic one. Overall safety and hyperkalaemia incidence were similar across HbA1c tertiles.
Type 1 diabetes has long been the population where cardiorenal trial evidence is thinnest, with practice extrapolated from type 2 cohorts. Evidence generated in type 1 patients specifically is the part that is genuinely new here.
- 242 adults with type 1 diabetes and albuminuric CKD, 6 months
- Placebo-corrected UACR -25% (95% CI -35% to -13%, P = 0.0001)
- Consistent across HbA1c tertiles (P interaction 0.41) and diabetes duration (0.70)
- HbA1c unchanged, so the benefit is not mediated by glycaemic control
- Hyperkalaemia incidence similar across HbA1c strata
The statistics, in plain English
"P for interaction 0.41" is the useful number. It tests whether the drug behaves differently in well- versus poorly-controlled patients. A high value means no detectable difference, so the single overall estimate of -25% is a reasonable expectation for any of these patients. The tertile with the largest apparent effect (-37%) is also the smallest subgroup, which is why the interaction test matters more than comparing subgroups by eye.
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