TACKLE-IT Trial - Treat Acute T Cell Rejection With Evidence and Confidence in Kidney Transplant Recipients
A Multicenter Randomized Controlled Trial to Treat Acute t Cell Mediated Rejection in Kidney and Kidney-pancreas Transplant Recipients
University of Sydney
540 participants
Mar 13, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria10
- 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 nephropathy.
- Active malignancies or active infection that preclude immunosuppression augmentation.
- Use of other immunomodulatory agents, including, but not limited to, Rituximab, Anti-TNF monoclonal antibody, Belatacept, Abatacept, Janus kinase inhibitors, Eculizumab, Pegcetacoplan.
- Enrolment in other interventional drug trials.
- Use of other investigational agents.
- Unable to adhere to the study protocol.
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Interventions
IV Methylprednisolone
Oral prednisone augmentation
Locations(25)
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NCT06474273