Status:
RECRUITING
The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Bayer
Conditions:
Kidney Transplant; Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 tran...
Detailed Description
Kidney transplantation yields significant improvements in morbidity, mortality, and quality of life for patients with end-stage kidney disease (ESKD), however, the burden from progressive chronic kidn...
Eligibility Criteria
Inclusion
- Clinical Trial
- 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
- 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
Key Trial Info
Start Date :
April 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06059664
Start Date
April 23 2024
End Date
September 30 2027
Last Update
May 25 2025
Active Locations (1)
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1
UNC Eastowne Kidney Transplant Clinic
Chapel Hill, North Carolina, United States, 27514