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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJean-Maxime Côté

About this trial

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.

Eligibility criteria

Qualifiers

Adult patients (≥18 years old) at the time of giving consent

Admitted to the hospital at the time of giving consent

KDIGO Stage ≥2 AKI confirmed by at least two separate creatinine measurements (definition: ≥2.0 times baseline creatinine, no urine output criteria)

Sustained AKI criteria for ≥48 hours since AKI diagnosis

Disqualifiers

Planned hospital discharge within 48 hours

Any ongoing use of MRA (spironolactone, eplerenone, finerenone), potassium-sparing diuretics (such as triamterene or amiloride), or potassium binders

Advanced CKD defined as eGFR ≤30 mL/min/1.73m² or undergoing KRT at baseline

Ongoing KRT at the time of randomization (Stage 3-dialysed AKI that partially/completely recovered and no longer required KRT at randomization can be included)

Trial design

Treatments tested in this trial

  • Finerenone (BAY94-8862 ) 10 mg
  • Placebo

Treatment groups

72 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Jean-Maxime Côté

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Sponsor institution