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

Eligibility 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).
• * 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
• * 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