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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Clinical Trial Who May Qualify: - 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 willing to sign a consent form - 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 Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Finerenone Oral Tablet

Blinded study of finerenone vs. placebo in kidney transplant recipients. Participants will take finerenone or placebo once daily for 12 months. The drug will be up- or down-titrated according to potassium levels.

DRUG

Placebo

Blinded study of finerenone vs. placebo in kidney transplant recipients. Participants will take finerenone or placebo once daily for 12 months. The drug will be up- or down-titrated according to potassium levels.

Locations (1)

UNC Eastowne Kidney Transplant Clinic
Chapel Hill, North Carolina, United States