This study is testing whether finerenone, when compared to placebo, is a tolerable and safe intervention when administered in patients with acute kidney injury (AKI). This study will explore whether finerenone can mitigate the risk of transitioning to chronic kidney disease following a moderate to severe AKI. Participants will be randomly assigned to receive either finerenone or a placebo, once daily for up to 45 days, in addition to their standard care. The study will monitor for side effects such as serum potassium levels and blood pressure, and will assess whether the drug helps prevent AKI from progressing to chronic kidney disease. This is a pilot feasibility study involving approximately 72 participants across 4-5 sites in Quebec and Ontario.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Finerenone 10mg, oral capsule, administered once daily for up to 45 days
Matching placebo capsule, identical in appearance to finerenone 10mg, administered orally once daily for up to 45 days
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Recruitment success
Enrollment of target population (72 participants) achieved within 2 years from first recruitment, accross at least 3 participating sites
Time frame: 2 years from first participant recruited
Adherence to study drug
Proportion of prescribed doses taken during the 45-day interventional period
Time frame: Day 1 to Day 45
Follow-up success (retention rate)
Proportion of surviving participants retained for the end-of-study visit (Day 90)
Time frame: Through Day 90
Incidence of hyperkalemia
Proportion of participants with serum/plasma potassium \>5.5 mmol/L (moderate: 5.5-6.0 mmol/L; severe: \>6.0 mmol/L), measured via local laboratories at any point during the interventional period
Time frame: Day 1 to Day 45
Incidence of hyponatremia
Proportion of participants with serum/plasma sodium \<130 mmol/L, measured via local laboratories at any point during the interventional period
Time frame: Day 1 to Day 45
Incidence of GFR worsening
Proportion of participants with ≥50% reduction in eGFR from randomization, calculated using local laboratory creatinine values (CKD-EPI 2021 equation)
Time frame: Day 1 to Day 45
Change in FiPAKI biomarkers panel
Change over time in plasma and urine biomarkers of kidney damage and fibrosis (creatinine, cystatin C, albumin, protein, YKL-40, DKK3, CCL14, TNFR1, Gal3, UMOD, NGAL)
Time frame: Baseline through Day 90
Change in eGFR
Change from baseline eGFR (calculated using CKD-EPI 2021 equation, race-omitted) at randomization, follow-up visits, and end-of-study
Time frame: Baseline to Day 90
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