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type1.science
Phase 3CompletedNCT05901831

FINE-ONE: finerenone for CKD associated with T1D

Completed randomized phase-3 trial of finerenone versus placebo on top of standard care in adults with T1D and albuminuric chronic kidney disease. It met its six-month albuminuria endpoint, but did not test kidney failure or cardiovascular outcomes.

Primary endpoints

  • Relative change in urinary albumin-to-creatinine ratio from baseline to six months

Results so far

The paper reports 242 randomized participants. UACR fell 34% with finerenone and 12% with placebo, a 25% greater reduction (ratio 0.75, 95% CI 0.65-0.87; P<0.001). Hyperkalemia occurred in 10.1% versus 3.3%, and 1.7% stopped finerenone because of it. This short surrogate-endpoint trial does not show fewer kidney failures, cardiovascular events, or deaths.