Clinical Trial

TACKLE-IT Trial - Treat Acute T Cell Rejection With Evidence and Confidence in Kidney Transplant Recipients

Recruiting Phase 3
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Summary
After a kidney or a simultaneous 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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-06-19; most recent amendment 2026-05-04.
Status change: Not Yet Recruiting → Recruiting 2026-05-04
Trial Details
NCT Number NCT06474273
Lead Sponsor University of Sydney
Collaborators: University of Manitoba
Conditions Rejection; Transplant, Kidney, Rejection; Transplant, Pancreas
Enrollment 540 participants
Start Date 2026-03-13
Primary Completion 2030-06 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-06