The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study

Criteria the registry did not label

• Clinical Trial Inclusion Criteria:
• Adult kidney transplant recipients ≥ 18 years
• 1 to 10 years post kidney transplantation from a deceased or living donor
• Stable kidney allograft function (within 20% baseline eGFR) and based on the clinical judgement of the investigator
• Preserved kidney allograft function defined as an eGFR ≥ 25 mL/min/1.73 m
• Urine albumin:creatinine ratio (UACR) ≥30 ug/mg
• Ability of the participant, or their legally authorized representative, to provide informed consent
• Contraceptive requirements:
• Women of non-childbearing potential do not need to undergo pregnancy testing or agree to use adequate contraception. Non-childbearing potential is defined as documented hysterectomy, bilateral salpingectomy, oophorectomy or postmenopausal females (amenorrhea for 12 months without an alternative medical cause). A single high follicle stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state.
• Women of childbearing potential can only be included if a pregnancy test is negative at the screening visit and if they agree to use adequate contraception during the study and until 8 weeks after the last study intervention dose. Adequate contraception is defined as an intrauterine device, implant or combined oral contraceptive with a physical barrier (e,g., condom).
  • Additional Inclusion Criteria for Kidney Biopsy Sub-study:
• Willingness to undergo research study biopsies at screening and following the 12 month treatment period
• Ability to safely discontinue antiplatelet or anticoagulant treatments
• No known intrinsic bleeding diathesis
• Hemoglobin \>9.0 g/dL; Platelets \> 100,000; International Normalised Ratio (INR) \<1.4 on the day of kidney biopsy
• Body mass index \<40
• Blood pressure controlled on the day of biopsy to \<160/90
  • Medical Condition Exclusion Criteria:
• Documented recurrent lupus nephritis, ANtineutrophilic Cytoplasmic Antibody (ANCA) vasculitis, membranoproliferative glomerulonephritis (including C3 glomerulopathy)
• History of solid organ transplantation other than kidney
• Acute kidney injury requiring dialysis within 6 months prior to screening
• Uncontrolled hypertension with a sitting Systolic Blood Pressure (SBP) ≥180 mmHg or Diastolic Blood Pressure (DBP) ≥100 mmHg
• Any indication for treatment with a steroidal MRA
• UACR \>3500 mg/g at screening. This may be reassessed if one of the three first morning urine samples is \>3500 mg/g at the screening visit
• CV event within 3 months prior to screening (heart failure requiring acute care, myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, elective coronary artery bypass grafting)
• Elective percutaneous coronary intervention within 1 month prior to screening
• Known hypersensitivity to the study treatment
• Addison's disease
• Hepatic insufficiency classified as Child-Pugh C
• Pregnancy, breast feeding or intention to become pregnant
  • Concomitant Therapies Exclusion Criteria:
• Concomitant therapy with spironolactone, eplerenone, sacubitril/valsartan combination, or potassium-sparing diuretic which cannot be discontinued at least 2 weeks prior to screening
• Simultaneous use of Angiotensin-Converting Enzyme Inhibitors (ACEI) and Angiotensin Receptor Blockers (ARB), without being able to discontinue one of these at least 2 weeks prior to screening
• Use of potent CYP3A4 inhibitors or inducers (to be stopped at least 7 days before randomization).
  • Other Exclusion Criteria:
• Participation in the MRI Study is excluded for certain pacemakers, electronic implants, shrapnel of the eye and certain types of aneurysm clips.
• Any other history, condition, or therapy which could, in the opinion of the investigator, affect compliance with the study treatment and procedures
• Close affiliation with the investigational site, investigators or staff
• Simultaneous participation in another interventional trial within 30 days prior to randomization