TACKLE-IT Trial - Treat Acute T Cell Rejection With Evidence and Confidence in Kidney Tran
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
| Condition(s) | Rejection; Transplant, Kidney, Rejection; Transplant, Pancreas |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Participants or their legal guardian must be able to understand and provide written informed consent; * Stated willingness to comply with all study procedures and availability for the duration of the study; * All ethnic and gender groups will have equal access to the study; * All children (aged 2+ years) and adults who have received a kidney or SPK transplant with biopsy proven acute TCMR (≥ Banff borderline (minimum i1 score) whether clinical or subclinical). Exclusion Criteria: * Mixed rejection. * Active or chronic active ABMR. * Chronic active TCMR. \*Patients with concomitant acute TCMR and chronic active TCMR will not be excluded from the trial. * Isolated v1 without inflammation. * Concurrent renal disease, such as recurrent glomerulonephritis or polyomavirus n |
| Ages | 2 Years |
| Sex | All |
| Lead sponsor | University of Sydney |
| Locations | Lambton, New South Wales, Australia; Randwick, New South Wales, Australia; Westmead, New South Wales, Australia; Westmead, New South Wales, Australia; South Brisbane, Queensland, Australia; Woolloongabba, Queensland, Australia (+19 more sites) |
| Start date | 2026-03-13 |
| NCT ID | NCT06474273 |
| Official listing | https://clinicaltrials.gov/study/NCT06474273 |