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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Finerenone (BAY94-8862 ) 10 mg
DrugFinerenone 10mg, oral capsule, administered once daily for up to 45 days
Placebo
DrugMatching placebo capsule, identical in appearance to finerenone 10mg, administered orally once daily for up to 45 days
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: FinerenoneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 recruited2
Adherence to study drug
Proportion of prescribed doses taken during the 45-day interventional period
Time frame
Day 1 to Day 453
Follow-up success (retention rate)
Proportion of surviving participants retained for the end-of-study visit (Day 90)
Time frame
Through Day 90Secondary outcomes
1
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 452
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 453
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 454
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 90Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jean-Maxime Côté
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor institution
Source ClinicalTrials.gov
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