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Highly Suppressive Treg in Delayed and Slow Graft Function After Kidney Transplantation

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 17, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jul 31, 2025 to Jul 31, 2026
    • Study completion date: Jul 31, 2025 to Jul 31, 2027
    v17
  2. Primary and study completion dates: Jul 31, 2024 to Jul 31, 2025v16
  3. Primary and study completion dates: Jan 31, 2024 to Jul 31, 2024v15
  4. Primary and study completion dates: Jul 31, 2023 to Jan 31, 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 140 to confirmed 180
    • Site details revised at 2 of 2 sites
    v14
  5. Study sites: 1 to 2
    • Primary completion date: Jul 1, 2024 to Jul 31, 2023
    • Study completion date: Jul 1, 2025 to Jul 31, 2023
    • Start date changed from estimate of Jan 1, 2023 to Dec 7, 2020
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Start date: Oct 1, 2022 to Jan 1, 2023v12
  2. Start date: Jul 1, 2022 to Oct 1, 2022v11
  3. Start date: Mar 1, 2022 to Jul 1, 2022v10
  4. Start date: Dec 1, 2021 to Mar 1, 2022v9
  5. Start date: Oct 1, 2021 to Dec 1, 2021v8
  6. Start date: Jul 1, 2021 to Oct 1, 2021v7
  7. Start date: Feb 1, 2021 to Jul 1, 2021v6
  8. Start date: Dec 1, 2020 to Feb 1, 2021v5
  9. Re-verified, no change to tracked fieldsv4
  10. Start date: Sep 1, 2020 to Dec 1, 2020v3
  11. Start date: Jul 1, 2020 to Sep 1, 2020
    • Site contact updated
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Delayed/slow graft function is the most common complication after kidney transplantation with an incidence over 20% and is the result of ischemia-reperfusion injury. The increased use of marginal kidney grafts to palliate the organ shortage is leading to a continued rise in the incidence of delayed/slow graft function. Delayed/slow graft function, however, is associated with an increased risk of acute rejection and graft failure. There are currently no clinically accepted biomarkers and no specific treatments for delayed/slow graft function. Regulatory T cells are protective in ischemia-reperfusion injury and rejection by suppressing pathologic immune responses. We hypothesize that the pre-transplant measurement of highly suppressive regulatory T cell is an accurate biomarker for delayed/slow graft function and its immunologic consequences. Ultimately, marginal kidney graft allocation could be directed to regulatory T cell-robust recipients and regulatory T cell-directed therapies could decrease marginal kidney graft discards without increasing delayed/slow graft function or impacting outcomes.
Trial Details
NCT Number NCT04414111
Lead Sponsor St. Louis University
Collaborators: Mid-America Transplant
Conditions
(from sponsor)		 DGF, Kidney Transplant; Complications
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov