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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: University of Sydney • ClinicalTrials.gov ID: NCT06474273

Registry updated: 2026-08-31
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Description

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.

Interventions

  • Methylprednisolone (Drug)
    IV Methylprednisolone
  • Prednisone (Drug)
    Oral prednisone augmentation

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). * Individuals with the following are eligible for inclusion: i. Concurrent acute TCMR and microvascular inflammation (MVI) defined as g+ptc, but without ABMR diagnosis. ii. Concurrent acute TCMR and chronic active TCMR. Exclusion Criteria: Individuals meeting any of the following criteria will be excluded from participation: * Mixed rejection. * Active or chronic active ABMR. * Chronic active TCMR. * 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.

Conditions

Rejection; Transplant, Kidney Rejection; Transplant, Pancreas

Locations

  • John Hunter Hospital — Lambton, New South Wales, Australia
  • Prince of Wales Hospital — Randwick, New South Wales, Australia
  • The Sydney Children's Hospital Network — Westmead, New South Wales, Australia
  • Westmead Hospital — Westmead, New South Wales, Australia
  • Queensland Children's Hospital — South Brisbane, Queensland, Australia
  • Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
  • Royal Adelaide Hospital — Adelaide, South Australia, Australia
  • Monash Medical Centre — Clayton, Victoria, Australia
  • Fiona Stanley Hospital — Murdoch, Western Australia, Australia
  • Royal Perth Children's hospital — Nedlands, Western Australia, Australia
  • Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
  • Foothills Medical Centre — Calgary, Alberta, Canada
  • Alberta Children's Hospital — Calgary, Alberta, Canada
  • Stollery Children's Hospital — Edmonton, Alberta, Canada
  • University of Alberta Hospital — Edmonton, Alberta, Canada
  • BC Children's Hospital — Vancouver, British Columbia, Canada
  • HSC Winnipeg Children's — Winnipeg, Manitoba, Canada
  • Health Sciences Center, University of Manitoba — Winnipeg, Manitoba, Canada
  • QEII Health Sciences Centre, Nova Scotia Health Authority — Halifax, Nova Scotia, Canada
  • London Health Science Centre — London, Ontario, Canada
  • St Mike's Hospital (Unity Health) — Toronto, Ontario, Canada
  • University of Toronto - Hospital for Sick Kids — Toronto, Ontario, Canada
  • Toronto General Hospital Research Institute (UHN) — Toronto, Ontario, Canada
  • Centre Hospitalier de l'université de Montréal (CHUM) — Montreal, Quebec, Canada
  • Glen Site — Montreal, Quebec, Canada
  • CHU Ste-Justine — Montreal, Quebec, Canada
  • Montreal Children's Hospital — Montreal, Quebec, Canada
  • CHU de Quebec — Québec, Quebec, Canada
  • St. Paul's Hospital — Saskatoon, Saskatchewan, Canada
  • Auckland City Hospital — Grafton, Auckland, New Zealand
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record