NCT06474273 TACKLE-IT Trial - Treat Acute T Cell Rejection With Evidence and Confidence in Kidney Transplant Recipients
| NCT ID | NCT06474273 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Sydney |
| Condition | Rejection; Transplant, Kidney |
| Study Type | INTERVENTIONAL |
| Enrollment | 540 participants |
| Start Date | 2026-03-13 |
| Primary Completion | 2030-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 540 participants in total. It began in 2026-03-13 with a primary completion date of 2030-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 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.
Contact & Investigator
NHMRC Clinical Trials Centre THE UNIVERSITY OF SYDNEY
✉ tackle-it.study@sydney.edu.au📞 +61 2 9562 5000
Germaine Wong, PhD, FRACP
PRINCIPAL INVESTIGATOR
University of Sydney
Frequently Asked Questions
Who can join the NCT06474273 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Rejection; Transplant, Kidney. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06474273 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 540 participants.
Is NCT06474273 currently recruiting?
Yes, NCT06474273 is actively recruiting participants. Contact the research team at tackle-it.study@sydney.edu.au for enrollment information.
Where is the NCT06474273 trial being conducted?
This trial is being conducted at Lambton, Australia, Randwick, Australia, Westmead, Australia, Westmead, Australia and 11 additional locations.
Who is sponsoring the NCT06474273 clinical trial?
NCT06474273 is sponsored by University of Sydney. The principal investigator is Germaine Wong, PhD, FRACP at University of Sydney. The trial plans to enroll 540 participants.
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