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A Multicenter Randomized Controlled Trial to Treat Acute T Cell Mediated Rejection in Kidney and Kidney-Pancreas Transplant Recipients

Study acronym: TACKLE-IT
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 3 changed
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Record History

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  1. Primary endpoint(s) modifiedv5 Show 5 more changesShow less
    • Trial sites expanded: 25 → 30 locations
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints revised (9)
    • Study description shortened, about 1 word
    • Study title expanded, about 2 words
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2025 to Mar 13, 2026
    • Site details revised at 25 of 25 sites
    v4
  3. Secondary endpoints: details revised at 1 of 9 entriesv3
  4. Phase: Phase 4 to Phase 3v2 Show 7 more changesShow less
    • Start date: Dec 2024 to Jun 2025
    • Primary endpoints revised (3)
    • Study sites: 22 to 25
    • Primary and study completion dates: Dec 2029 to Jun 2030
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: 10 to 9
    • Study description expanded, about 36 words
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
After a kidney or a kidney-pancreas transplant, some patients may face problems with their new organs. This happens because the body sometimes makes a mistake and tries to get rid of the organ. This problem is called rejection. One type of rejection is known as Acute T cell mediated rejection (TCMR). This can lead to many problems or even stop the transplant from working. Doctors give strong steroids to treat this problem, but there are no rules for how much steroid to give. Too much steroids can cause problems like heart and bone problems, bad infections, and weight gain. That is why we need to find the right dose of steroids for each person to treat this. TACKLE-IT is a study that will try to find the right steroid dose for treating rejection.
Trial Details
NCT Number NCT06474273
Lead Sponsor University of Sydney
Collaborators: University of Manitoba
Conditions
(from sponsor)		 Rejection; Transplant, Kidney, Rejection; Transplant, Pancreas
Related terms Rejection, Psychology
Enrollment 540 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov