Acute Kidney InjuryFiPAKINCT07775482
Finerenone for AKI: a Multicenter, Randomized, Placebo-Controlled Feasibility Pilot Trial
A study testing Finerenone (BAY94-8862 ) 10 mg in people with Acute Kidney Injury and Renal Insufficiency,Chronic, run by Jean-Maxime Côté at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Renal Insufficiency,Chronic, Kidney Diseases
- What is being tested?
- Finerenone (BAY94-8862 ) 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2027to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
PARC PADOC, 514-890-8000 ext. 15379, parc.padoc.chum@ssss.gouv.qc.ca
Amel Zertal, M. Sc., 514-890-8000 ext. 30883, amel.zertal.chum@ssss.gouv.qc.ca
About this study
Official title: 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.
Read the 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.
- Being tested
- Finerenone (BAY94-8862 ) 10 mg, Placebo
- Keywords
- Finerenone, Acute kidney injury, AKI to CKD transition, Chronic kidney disease, Renal fibrosis, Mineralocorticoid receptor antagonist, Hyperkalemia, Pilot study, Feasibility trial, Nephroprotection
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic, Kidney Diseases, Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finerenone (BAY94-8862 ) 10 mgDrug
Also called Kerendia
Finerenone 10mg, oral capsule, administered once daily for up to 45 days
PlaceboDrug
Matching placebo capsule, identical in appearance to finerenone 10mg, administered orally once daily for up to 45 days
| Study group | Role | What they receive |
|---|---|---|
| Finerenone | Experimental | Finerenone, 10mg, oral, once daily, for up to 45 days Receives: Drug: Finerenone (BAY94-8862 ) 10 mg |
| Placebo | Placebo comparator | Matching placebo, oral, once daily, for up to 45 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment success
Enrollment of target population (72 participants) achieved within 2 years from first recruitment, accross at least 3 participating sites
Measured: 2 years from first participant recruited
Adherence to study drug
Proportion of prescribed doses taken during the 45-day interventional period
Measured: Day 1 to Day 45
Follow-up success (retention rate)
Proportion of surviving participants retained for the end-of-study visit (Day 90)
Measured: Through Day 90
Secondary outcomes (5)
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
Measured: Day 1 to Day 45
Incidence of hyponatremia
Proportion of participants with serum/plasma sodium <130 mmol/L, measured via local laboratories at any point during the interventional period
Measured: Day 1 to Day 45
Incidence of GFR worsening
Proportion of participants with ≥50% reduction in eGFR from randomization, calculated using local laboratory creatinine values (CKD-EPI 2021 equation)
Measured: Day 1 to Day 45
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)
Measured: Baseline through Day 90
Change in eGFR
Change from baseline eGFR (calculated using CKD-EPI 2021 equation, race-omitted) at randomization, follow-up visits, and end-of-study
Measured: Baseline to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jean-Maxime Côté
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jean-Maxime Côté, Centre hospitalier de l'Université de Montréal (CHUM)
- Investigators
- Jean-Maxime Côté, MD, MSc., FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775482
- Sponsor's protocol ID
- FiPAKI
- Acronym
- FiPAKI
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07775482
- Acronym / sponsor ID
- FiPAKI / FiPAKI
- Keywords
- Finerenone, Acute kidney injury, AKI to CKD transition, Chronic kidney disease, Renal fibrosis, Mineralocorticoid receptor antagonist, Hyperkalemia, Pilot study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Jean-Maxime CôtéUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Finerenone | Experimental | Drug: Finerenone (BAY94-8862 ) 10 mgFinerenone, 10mg, oral, once daily, for up to 45 days |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo, oral, once daily, for up to 45 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finerenone (BAY94-8862 ) 10 mgAlso: KerendiaFinerenone 10mg, oral capsule, administered once daily for up to 45 days | Drug | Finerenone |
| PlaceboMatching placebo capsule, identical in appearance to finerenone 10mg, administered orally once daily for up to 45 days | Drug | Placebo |
Primary outcome
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
Adherence to study drug
Time frame: Day 1 to Day 45
Proportion of prescribed doses taken during the 45-day interventional period
Follow-up success (retention rate)
Time frame: Through Day 90
Proportion of surviving participants retained for the end-of-study visit (Day 90)
5 secondary outcomes
Incidence of hyperkalemia
Time frame: Day 1 to Day 45
Incidence of hyponatremia
Time frame: Day 1 to Day 45
Incidence of GFR worsening
Time frame: Day 1 to Day 45
Change in FiPAKI biomarkers panel
Time frame: Baseline through Day 90
Change in eGFR
Time frame: Baseline to Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Maxime Côté, MD, MSc., FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finerenone (BAY94-8862 ) 10 mg in people with Acute Kidney Injury and Renal Insufficiency,Chronic, run by Jean-Maxime Côté at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Maxime Côté, MD, MSc., FRCPC (514-890-8444, parc.padoc.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment success (time frame: 2 years from first participant recruited). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.