The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study
University of North Carolina, Chapel Hill
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 transplant recipients (KTRs). One hundred fifty (150) KTRs will be randomized in a 2:1 ratio of finerenone to placebo, with two embedded substudies: (i) a kidney biopsy substudy in 50 participants who undergo a research kidney biopsy prior to randomization and at the end of active treatment; and (ii) a functional MRI (fMRI) substudy in 50 participants who undergo fMRI prior to randomization and at the end of active treatment.
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 kidney disease (CKD), cardiovascular (CV) events and death remain high. CKD is the result of several pathologic processes, including diabetic and hypertensive sclerosis, calcineurin inhibitor toxicity (CNIT), chronic inflammation and fibrosis that ensues post-acute rejection episodes and other nonspecific insults that can result in CKD mediators. Currently, mean allograft survival is currently 8 years…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 pre…
Interventions
- DrugFinerenone Oral Tablet
Blinded study of finerenone vs. placebo in kidney transplant recipients. Participants will take finerenone or placebo once daily for 12 months. The drug will be up- or down-titrated according to potassium levels.
- DrugPlacebo
Blinded study of finerenone vs. placebo in kidney transplant recipients. Participants will take finerenone or placebo once daily for 12 months. The drug will be up- or down-titrated according to potassium levels.
Location
- UNC Eastowne Kidney Transplant ClinicChapel Hill, North Carolina