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

Finerenone to Improve Acute Kidney Injury; a Multicenter, Randomized, Placebo-Controlled Study to Investigate the Feasibility of Finerenone in Treating Patients With Acute Kidney Injury (FiPAKI Pilot 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.

Inclusion Criteria:

• 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
• No AKI progression before randomization (as per the judgement of the investigator)
• Serum potassium ≤4.8 mmol/L within 48 hours before randomization
• Suspected intrinsic AKI (hemodynamic and obstructive AKI has been ruled out according to the judgment of the investigator)
• Participant should be capable of giving signed informed consent, which includes compliance with the requirements and restrictions of the participating site

Exclusion Criteria:

• 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)
• Clinically unstable (based on investigator clinical evaluation, i.e., vasopressors, uncontrolled sepsis)
• Confirmed or suspected glomerular disease (other than diabetes) or acute interstitial nephritis requiring immunosuppressive therapy as the primary cause of AKI
• Previous hypersensitivity to finerenone
• Documented history of adrenal insufficiency or Addison's disease
• Concomitant therapy with strong CYP3A4 inhibitors, if conversion to another medication is not feasible
• Clinician judgment that the intervention is contraindicated due to: A) risk of hyperkalemia; B) risk of KRT initiation within the next 7 days (anuria or rapid increase in serum creatinine); C) impossibility to administer potassium binders
• Enrollment in another clinical trial that could impact potassium, GFR, or kidney function
• For women who are able to become pregnant: positive pregnancy test and/or being breastfeeding at screening
• Any other condition or therapy, in the judgement of the Investigator or the Sponsor, which could make the participant unsuitable for this study, including a condition or therapy which the Investigator anticipates will not allow participation for the full planned study period (i.e., condition limiting life expectancy to less than 3 months)