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

NCT07775482 | Not Yet Recruiting DMC

• 1 other identifier: FiPAKI
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Kidney Injury; Renal Insufficiency,Chronic; Kidney Diseases

Keywords

Finerenone; Acute kidney injury; AKI to CKD transition; Chronic kidney disease; Renal fibrosis; Mineralocorticoid receptor antagonist; Hyperkalemia; Pilot study; Feasibility trial; Nephroprotection

Outcome Measures

Primary Outcomes (3)

• Recruitment success

  Enrollment of target population (72 participants) achieved within 2 years from first recruitment, accross at least 3 participating sites

  2 years from first participant recruited

• Adherence to study drug

  Proportion of prescribed doses taken during the 45-day interventional period

  Day 1 to Day 45

• Follow-up success (retention rate)

  Proportion of surviving participants retained for the end-of-study visit (Day 90)

  Through Day 90

Secondary Outcomes (5)

• Incidence of hyperkalemia

  Day 1 to Day 45

• Incidence of hyponatremia

  Day 1 to Day 45

• Incidence of GFR worsening

  Day 1 to Day 45

• Change in FiPAKI biomarkers panel

  Baseline through Day 90

• Change in eGFR

  Baseline to Day 90

Study Arms (2)

Finerenone

EXPERIMENTAL

Finerenone, 10mg, oral, once daily, for up to 45 days

Drug: Finerenone (BAY94-8862 ) 10 mg

Placebo

PLACEBO COMPARATOR

Matching placebo, oral, once daily, for up to 45 days

Drug: Placebo

Interventions

Finerenone (BAY94-8862 ) 10 mg DRUG

Finerenone 10mg, oral capsule, administered once daily for up to 45 days

Also known as: Kerendia

Finerenone

Placebo DRUG

Matching placebo capsule, identical in appearance to finerenone 10mg, administered orally once daily for up to 45 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jean-Maxime Côté: lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

Location

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic; Kidney Diseases; Hyperkalemia

Interventions

finerenone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jean-Maxime Côté, MD, MSc., FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Maxime Côté, MD, MSc., FRCPC

CONTACT

514-890-8444; parc.padoc.chum@ssss.gouv.qc.ca

PARC PADOC

CONTACT

514-890-8000; parc.padoc.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study. Neither participants nor their study doctors will know treatment group assignment. Finerenone and placebo will be prepared as identical-appearing capsules, compounded and packaged to be indistinguishable in appearance. Two designated blinded / unblinded CRAs will manage drug allocation and monitoring : unblinding will occur in emergency situations where knowledge of treatment assignment is required for the participant's medical care.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nephrologist - MD, MSc., FRCPC

Model Details: Participants will be randomized in a 1:1 ratio to receive either finerenone 10mg or matching placebo, administered orally once daily for up to 45 days, in parallel treatment arms, in addition to standard of care.

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)