Effect of Finerenone on Kidney Transplant Recipients
The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study
This study is testing if a new medication called finerenone can help kidney transplant recipients stay healthy and avoid complications related to their kidneys and heart.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06059664 on ClinicalTrials.gov |
What this trial studies
The EFFEKTOR study is a multicenter, phase 2 clinical trial designed to evaluate the safety, tolerability, and efficacy of finerenone in kidney transplant recipients. A total of 150 participants will be randomly assigned to receive either finerenone or a placebo in a 2:1 ratio. The study includes two substudies: one involving kidney biopsies and another utilizing functional MRI to assess kidney and cardiovascular health. The aim is to address the high rates of chronic kidney disease and cardiovascular complications in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adult kidney transplant recipients aged 18 years or older, who are 1 to 10 years post-transplant with stable kidney function.
Not a fit: Patients with unstable kidney function or those who are not within the specified time frame post-transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney and cardiovascular outcomes for kidney transplant recipients.
How similar studies have performed: While the approach of using finerenone in this specific population is novel, similar studies targeting cardiovascular outcomes in kidney transplant recipients have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chapel Hill, North Carolina
- UNC Eastowne Kidney Transplant Clinic — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Amy Mottl, MD, MPH — University of North Carolina, Chapel Hill
- Study coordinator: Amy Mottl, MD, MPH
- Email: amy_mottl@med.unc.edu
- Phone: 919-445-2641
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.