RecruitingPhase 2NCT06059664

The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study

Sponsor

University of North Carolina, Chapel Hill

Enrollment

100 participants

Start Date

Apr 23, 2024

Study Type

INTERVENTIONAL

Conditions

Kidney Transplant; Complications

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a drug called finerenone (used for heart and kidney conditions) can help protect a transplanted kidney from deteriorating in recipients who have some protein leaking into their urine, a sign of early kidney stress. **You may be eligible if...** - You are 18 or older - You received a kidney transplant between 1 and 10 years ago from a living or deceased donor - Your transplanted kidney is functioning stably - Your kidney's filtering rate (eGFR) is at least 25 mL/min/1.73m2 - You have some protein in your urine (urine albumin-to-creatinine ratio of 30 or more) **You may NOT be eligible if...** - Your kidney transplant was less than 1 year or more than 10 years ago - Your kidney function has been unstable recently - You have very high potassium levels or other conditions that make finerenone unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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