The EFFEKTOR Study: Finerenone for Kidney Transplant Recipients
This study, called EFFEKTOR, is testing a drug called finerenone against a placebo (an inactive pill) in people who have received a kidney transplant. The goal is to see if finerenone is safe, well-tolerated, and effective in improving outcomes for kidney transplant recipients. You would take either finerenone or placebo once a day for 12 months, with the dose adjusted based on your potassium levels. To join, you need to be an adult (18 or older) who received a kidney transplant 1 to 10 years ago, with stable kidney function (eGFR of 25 mL/min or higher). This initial phase of the study is focused on whether it's possible to successfully recruit participants for a larger trial.
- Study design
- This is a vanguard, multicenter, phase 2 randomized, double-blinded, placebo-controlled study. It aims to enroll 100 participants.
- What's involved
- You would take finerenone or placebo once daily for 12 months. Some participants may also have kidney biopsies or functional MRI scans before and after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for this study are measured up to 3 months after launching the full study protocol.
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NCT06059664
The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of North Carolina, Chapel HillInvestigator-initiated
~100 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:Finerenone Oral TabletPlacebo
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of recruitment to the main clinical trial: Total number of participants who were eligible and enrolled in the main clinical trial
Measured over Up to 3 months after launching the full study protocol
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesNorth Carolina1
Study leadership
- Amy Mottl, MD, MPH · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill
- Prabir Roy-Chaudhury, MD, PhD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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).
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
Exclusion
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 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).
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
What this trial measures
- Feasibility of recruitment to the main clinical trial: Total number of participants who were eligible and enrolled in the main clinical trialUp to 3 months after launching the full study protocol
Signed consent by 30 participants for the main clinical trial within 3 months of launching the full study protocol (date of first person randomized).
- Feasibility of recruitment to the kidney biopsy substudy: Total number of participants who were eligible and enrolled in the kidney biopsy substudyUp to 3 months after launching the full study protocol
Signed consent by 10 participants for the biopsy substudy within 3 months of launching the full study protocol (date of first person randomized).