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

Sponsor
Jean-Maxime Côté
Study ID
NCT07775482
Status
Not Yet Recruiting

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Conditions

  • Acute Kidney Injury
  • Kidney Diseases
  • Renal Insufficiency,Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Finerenone (BAY94-8862 ) 10 mg — DRUG
    Finerenone 10mg, oral capsule, administered once daily for up to 45 days
  • Placebo — DRUG
    Matching placebo capsule, identical in appearance to finerenone 10mg, administered orally once daily for up to 45 days

Study Details

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.

Key Dates

First listed
Aug 20, 2026
Start date
Jan 31, 2027
Status verified
Aug 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Finerenone
    Finerenone, 10mg, oral, once daily, for up to 45 days
  • Placebo Comparator: Placebo
    Matching placebo, oral, once daily, for up to 45 days

Primary Outcome Measure

Recruitment success [ Time Frame: 2 years from first participant recruited ]

Central Contacts

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