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Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation

StatusEnrolling by Invitation
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jan 15, 2025 to Jun 2027 Completion date: Sep 15, 2025 to Dec 2027v3 Show 1 more changeShow less
    • Completion date: Sep 15, 2025 to Dec 2027
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation Start date changed from estimate of Apr 15, 2022 to Jul 28, 2022 · Primary completion date: Oct 15, 2024 to Jan 15, 2025 · Completion date: Jun 15, 2025 to Sep 15, 2025 · 2 morev2 Show 5 more changesShow less
    • Start date changed from estimate of Apr 15, 2022 to Jul 28, 2022
    • Primary completion date: Oct 15, 2024 to Jan 15, 2025
    • Completion date: Jun 15, 2025 to Sep 15, 2025
    • Site contact updated
    • Study description expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a randomized, double-blind, placebo-controlled trial in de novo kidney transplant patients to determine if the addition of fingolimod (brand name Gilenya®, candidate name- FTY720) on the background of standard immunosuppression will prevent expansion of the interstitial compartment of the transplanted kidney. Interstitial expansion is the precursor of interstitial fibrosis and graft loss. The study will test the hypothesis that abgrogating the fibrogenic effects of both the RhoA and mTOR pathways with fingolimod will reduce structural damage in transplanted kidneys and possible subsequent transplant failure.
Trial Details
NCT Number NCT05285878
Lead Sponsor The Methodist Hospital Research Institute
Conditions Interstitial Fibrosis, Kidney Transplant; Complications, Kidney Transplant Rejection, Kidney Transplant Failure and Rejection, Kidney Transplant Failure, Kidney Failure, Chronic, Graft Rejection
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov