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.
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
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
University of North Carolina, Chapel Hill
Lead sponsor
Bayer
Collaborator
Weill Medical College of Cornell University
Collaborator
University of Cincinnati
Collaborator