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

RecruitingPhase 3Ages 2 Years - anyAllUniversity of Sydney
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 (โ‰ฅ 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.
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What it tests

  • Methylprednisolone
  • Prednisone
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Where

30 sites
John Hunter Hospital
Lambton, Australia
Prince of Wales Hospital
Randwick, Australia
The Sydney Children's Hospital Network
Westmead, Australia
Westmead Hospital
Westmead, Australia
Queensland Children's Hospital
South Brisbane, Australia
Princess Alexandra Hospital
Woolloongabba, Australia
Royal Adelaide Hospital
Adelaide, Australia
Monash Medical Centre
Clayton, Australia

โ€ฆand 22 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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