Finerenone for AKI: a Multicenter, Randomized, Placebo-Controlled Feasibility Pilot Trial

Finerenone is a nonsteroidal mineralocorticoid receptor antagonist (MRA) that blocks mineralocorticoid receptor overactivation, a pathway implicated in inflammatory and fibrotic processes in the kidney. It is currently approved for use in chronic kidney disease associated with type 2 diabetes and in heart failure. Its potential role in preventing the transition from AKI to irreversible CKD has not yet been established, and its use in this population is considered experimental. This is a multicenter, randomized, double-blind, placebo-controlled pilot feasibility trial designed to evaluate the tolerability and safety of finerenone initiated in hospitalized adult patients with moderate to severe AKI (defined by at least a doubling of serum creatinine). Approximately 72 participants will be enrolled across 4-5 sites in Quebec and Ontario. Eligible participants will be randomized in a 1:1 ratio to receive either finerenone 10 mg or matching placebo, administered orally once daily for up to 45 days. Participants will be followed for 90 days. The primary objective is to assess the tolerability and safety of finerenone compared to placebo in this population. Secondary and exploratory objectives include evaluating biological markers of kidney injury and fibrosis, with the goal of informing the design of a future, larger efficacy trial. The study is funded by the Kidney Foundation of Canada and is being conducted under an approval from Health Canada specific to this trial.