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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 150 to 100 Primary completion date: Sep 30, 2026 to Mar 31, 2027 · Completion date: Sep 30, 2027 to Dec 31, 2027 · Collaborators: 1 to 3v6 Show 3 more changesShow less
    • Primary completion date: Sep 30, 2026 to Mar 31, 2027
    • Completion date: Sep 30, 2027 to Dec 31, 2027
    • Collaborators: 1 to 3

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Feb 1, 2025 to Sep 30, 2026 Completion date: May 1, 2026 to Sep 30, 2027v5 Show 1 more changeShow less
    • Completion date: May 1, 2026 to Sep 30, 2027
  3. Primary completion date: Jul 2024 to Feb 1, 2025 Start date: Mar 1, 2024 to Apr 23, 2024 · Completion date: Dec 2025 to May 1, 2026v4 Show 2 more changesShow less
    • Start date: Mar 1, 2024 to Apr 23, 2024
    • Completion date: Dec 2025 to May 1, 2026
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 1, 2023 to Mar 1, 2024 · Primary completion date: Nov 2024 to Jul 2024 · Site details revisedv3 Show 3 more changesShow less
    • Start date changed from estimate of Nov 1, 2023 to Mar 1, 2024
    • Primary completion date: Nov 2024 to Jul 2024
    • Site details revised
  5. Study description revised Publications: 2 to 17v2 Show 1 more changeShow less
    • Publications: 2 to 17

    See this version in full on ClinicalTrials.gov ↗

  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06059664
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: Bayer, Weill Medical College of Cornell University, University of Cincinnati
Conditions Kidney Transplant; Complications
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov