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.
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Feasibility of recruitment to the main clinical trial: Total number of participants who were eligible and enrolled in the main clinical trial
Timeframe: Up to 3 months after launching the full study protocol
Feasibility of recruitment to the kidney biopsy substudy: Total number of participants who were eligible and enrolled in the kidney biopsy substudy
Timeframe: Up to 3 months after launching the full study protocol