NCT06059664 The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study
| NCT ID | NCT06059664 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Kidney Transplant; Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-04-23 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-04-23 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Amy Mottl, MD, MPH
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06059664 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Transplant; Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06059664 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06059664 currently recruiting?
Yes, NCT06059664 is actively recruiting participants. Contact the research team at amy_mottl@med.unc.edu for enrollment information.
Where is the NCT06059664 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06059664 clinical trial?
NCT06059664 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Amy Mottl, MD, MPH at University of North Carolina, Chapel Hill. The trial plans to enroll 100 participants.
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