Effect of Finerenone on Kidney Transplant Recipients
Official title: The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study
Run by University of North Carolina, Chapel Hill · NCT06059664 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Status | Recruiting |
| Started | April 23, 2024 |
| Main results expected | March 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | April 14, 2026 |
| Trial ID | NCT06059664 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the approach of using finerenone in this specific population is novel, similar studies targeting cardiovascular outcomes in kidney transplant recipients have shown promise.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Omnisol-preserved kidneys before transplant (hypothermic machine perfusion)
This study tests whether using Omnisol during hypothermic machine perfusion before kidney transplant can improve early graft function compared with standard preservation.
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How Propofol and Sevoflurane Affect miRNA in Living Kidney Donors
This study tests whether using propofol or sevoflurane during donor nephrectomy changes levels of miRNAs in living kidney donors.
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Effects of general vs spinal-epidural anesthesia on kidney transplant biomarkers
This study tests whether sevoflurane general anesthesia or combined spinal-epidural anesthesia changes markers of cellular stress and protective peptides in adults undergoing kidney transplantation.
-
How kidney transplant patients feel about using artificial intelligence in medicine
This international survey asks adults who have had a kidney transplant how they feel about AI tools that predict graft loss and what it might mean for their daily care.
-
Personalized therapeutic stories for children after kidney transplant.
We will test whether clinician-supervised AI can create age-appropriate, personalized therapeutic stories for children aged 5–12 who have received a kidney transplant and their families.
-
Treating blood vessel problems after a kidney transplant
This effort will try catheter-based angioplasty and advanced imaging to see if they help kidney transplant recipients with graft dysfunction or stubborn high blood pressure from possible transplant blood‑vessel problems.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.