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

August 17, 2026 updated by: Jean-Maxime Côté

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Finerenone is a nonsteroidal mineralocorticoid receptor antagonist (MRA) that blocks mineralocorticoid receptor overactivation, a pathway implicated in inflammatory and fibrotic processes in the kidney. It is currently approved for use in chronic kidney disease associated with type 2 diabetes and in heart failure. Its potential role in preventing the transition from AKI to irreversible CKD has not yet been established, and its use in this population is considered experimental.

This is a multicenter, randomized, double-blind, placebo-controlled pilot feasibility trial designed to evaluate the tolerability and safety of finerenone initiated in hospitalized adult patients with moderate to severe AKI (defined by at least a doubling of serum creatinine). Approximately 72 participants will be enrolled across 4-5 sites in Quebec and Ontario.

Eligible participants will be randomized in a 1:1 ratio to receive either finerenone 10 mg or matching placebo, administered orally once daily for up to 45 days. Participants will be followed for 90 days.

The primary objective is to assess the tolerability and safety of finerenone compared to placebo in this population. Secondary and exploratory objectives include evaluating biological markers of kidney injury and fibrosis, with the goal of informing the design of a future, larger efficacy trial.

The study is funded by the Kidney Foundation of Canada and is being conducted under an approval from Health Canada specific to this trial.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Finerenone
Finerenone, 10mg, oral, once daily, for up to 45 days
Drug: Finerenone (BAY94-8862 ) 10 mg
Finerenone 10mg, oral capsule, administered once daily for up to 45 days
Other Names:
  • Kerendia
Placebo Comparator: Placebo
Matching placebo, oral, once daily, for up to 45 days
Drug: Placebo
Matching placebo capsule, identical in appearance to finerenone 10mg, administered orally once daily for up to 45 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment success
Time Frame: 2 years from first participant recruited
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
Time Frame: Day 1 to Day 45
Proportion of prescribed doses taken during the 45-day interventional period
Day 1 to Day 45
Follow-up success (retention rate)
Time Frame: Through Day 90
Proportion of surviving participants retained for the end-of-study visit (Day 90)
Through Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hyperkalemia
Time Frame: Day 1 to Day 45
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
Day 1 to Day 45
Incidence of hyponatremia
Time Frame: Day 1 to Day 45
Proportion of participants with serum/plasma sodium <130 mmol/L, measured via local laboratories at any point during the interventional period
Day 1 to Day 45
Incidence of GFR worsening
Time Frame: Day 1 to Day 45
Proportion of participants with ≥50% reduction in eGFR from randomization, calculated using local laboratory creatinine values (CKD-EPI 2021 equation)
Day 1 to Day 45
Change in FiPAKI biomarkers panel
Time Frame: Baseline through Day 90
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)
Baseline through Day 90
Change in eGFR
Time Frame: Baseline to Day 90
Change from baseline eGFR (calculated using CKD-EPI 2021 equation, race-omitted) at randomization, follow-up visits, and end-of-study
Baseline to Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jean-Maxime Côté

Investigators

  • Principal Investigator: Jean-Maxime Côté, MD, MSc., FRCPC, Centre Hospitalier de l'Université de Montréal (CHUM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

August 17, 2026

First Submitted That Met QC Criteria

August 17, 2026

First Posted (Actual)

August 20, 2026

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FiPAKI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared publicly. Coded (pseudonymized) data and residual biological samples may be retained for future AKI-related research, subject to separate ethics committee approval, as described in the informed consent process.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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