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

Summary

EFFEKTOR is a vanguard, multicenter, phase 2 randomized, double blinded, placebo controlled clinical trial to determine the feasibility, tolerability, safety, and efficacy of finerenone in kidney transplant recipients (KTRs). One hundred fifty (150) KTRs will be randomized in a 2:1 ratio of finerenone to placebo, with two embedded substudies: (i) a kidney biopsy substudy in 50 participants who undergo a research kidney biopsy prior to randomization and at the end of active treatment; and (ii) a functional MRI (fMRI) substudy in 50 participants who undergo fMRI prior to randomization and at the end of active treatment.

Eligibility

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

Conditions2

Locations1 site

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