Finerenone for Kidney Transplant Recipients
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as spironolactone, eplerenone, sacubitril/valsartan, potassium-sparing diuretics, and some blood pressure medications, at least 2 weeks before screening. You also need to stop using certain enzyme-affecting drugs at least 7 days before randomization.
What data supports the effectiveness of the drug Finerenone for kidney transplant recipients?
How is the drug Finerenone unique for kidney transplant recipients?
Finerenone is unique because it is a non-steroidal mineralocorticoid receptor antagonist, which means it works differently from traditional immunosuppressive drugs used in kidney transplants that often involve steroids or calcineurin inhibitors. This could potentially reduce the side effects associated with these other treatments.678910
Research Team
Amy Mottl, MD, MPH
Principal Investigator
University of North Carolina, Chapel Hill
Prabir Roy-Chaudhury, MD, PhD
Principal Investigator
University of North Carolina, Chapel Hill
Eligibility Criteria
The EFFEKTOR study is for adult kidney transplant recipients who are 1 to 10 years post-transplant with a certain level of protein in their urine and stable kidney function. Participants must agree to use contraception if of childbearing potential, or be confirmed not of childbearing potential.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive finerenone or placebo with dose titration based on potassium levels
Follow-up
Participants are monitored for safety and effectiveness after treatment
Kidney Biopsy Substudy
Participants undergo kidney biopsy before randomization and at the end of active treatment
Functional MRI Substudy
Participants undergo fMRI before randomization and at the end of active treatment
Treatment Details
Interventions
- Finerenone
- Placebo
Finerenone is already approved in United States, European Union for the following indications:
- Chronic kidney disease associated with type 2 diabetes
- Chronic kidney disease associated with type 2 diabetes
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
Bayer
Industry Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD