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
Parallel
Finerenone Oral Tablet
DrugBlinded 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.
Placebo
DrugBlinded 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.
Feasibility of recruitment to the main clinical trial: Total number of participants who were eligible and enrolled in the main clinical trial
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 substudy
Signed consent by 10 participants for the biopsy substudy within 3 months of launching the full study protocol (date of first person randomized).
Relative tolerability of finerenone
Relative tolerability is defined as the percent time spent on the investigational product.
Risk for discontinuation of finerenone
The number of the participants who permanently discontinue the investigational product prior to the last on study drug visit, divided by the total number of study participants in the same treatment group.
Overall safety of finerenone
The percentage of participants suffering a serious adverse event or adverse event of interest (hyperkalemia, acute kidney injuries) while on study drug.
Adverse Event (AE) related to hyperkalemia
The percentage of participants requiring acute care (hospitalization or ER visit) for hyperkalemia, while on study drug.
Efficacy for functional Magnetic Resonance Imaging (fMRI) kidney oxygenation
Difference between active versus placebo groups with respect to absolute change in fMRI measures of cortical oxygen availability, estimated by R2\* (s-1) using blood oxygenation level dependent (BOLD) MRI
Efficacy for functional Magnetic Resonance Imaging (fMRI) kidney perfusion
Difference between active versus placebo groups with respect to absolute change in fMRI measures of cortical perfusion (ml/min/100g), estimated using arterial spin labeling (ASL) MRI
Efficacy for functional Magnetic Resonance Imaging (fMRI) kidney fibrosis
Difference between active versus placebo groups with respect to absolute change in fMRI cortical fibrosis, estimated by apparent diffusion coefficient (ADC), (x10-3/s) using diffusion-weighted MRI.
Efficacy for interstitial fibrosis and tubular atrophy (IFTA)
Difference between active versus placebo groups with respect to absolute change in percent of cortex with IFTA
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
Bayer
Collaborator
Weill Medical College of Cornell University
Collaborator
University of Cincinnati
Collaborator
