NCT07775482Not yet recruiting
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)
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 17 Aug 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Jean-Maxime Côté
- Diseases
- Chronic kidney disease
- NCT number
- NCT07775482
What you commit to
- Study type: Interventional
- Planned participants: 72
- From 1 Jan 2027 to the primary completion date, 31 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous hypersensitivity to finerenone
- Concomitant therapy with strong CYP3A4 inhibitors, if conversion to another medication is not feasible
Other illness
- Confirmed or suspected glomerular disease (other than diabetes) or acute interstitial nephritis requiring immunosuppressive therapy as the primary cause of AKI
- Documented history of adrenal insufficiency or Addison's disease
- 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)
Lab values
- 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
- 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
Other
- Planned hospital discharge within 48 hours
- 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)
- For women who are able to become pregnant: positive pregnancy test and/or being breastfeeding at screening
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.