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

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Sep 25, 2023

Keywords

ClinConnect Summary

The EFFEKTOR Study is a clinical trial designed to test a medication called finerenone in people who have received a kidney transplant. This study aims to see how well finerenone works, how safe it is, and if patients can tolerate it. The trial will include 150 kidney transplant recipients who are at least 18 years old and have stable kidney function. Participants will be randomly assigned to receive either finerenone or a placebo (a sugar pill with no active medication). There are also two special parts of the study where some participants will undergo kidney biopsies and functional MRI scans to gather more information about their kidney health during the trial.

To be eligible for the study, participants need to have received their kidney transplant between 1 and 10 years ago, have a certain level of kidney function, and meet other health criteria. If you decide to participate, you can expect regular check-ups and tests to monitor your health throughout the study. This trial is important because it could lead to new treatments that help improve the health of kidney transplant recipients and reduce complications.

Gender

ALL

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