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

Korábbi kezelés

• Previous hypersensitivity to finerenone
• Concomitant therapy with strong CYP3A4 inhibitors, if conversion to another medication is not feasible

Más betegség

• 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)

Laborértékek

• 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

Egyéb

• 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

• 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