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RECRUITING
NCT06059664
PHASE2

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

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-04-23

Completion Date

2027-09-30

Last Updated

2025-05-25

Healthy Volunteers

No

Interventions

DRUG

Finerenone 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.

DRUG

Placebo

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.

Locations (1)

UNC Eastowne Kidney Transplant Clinic

Chapel Hill, North Carolina, United States