University of Sydney
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's 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.
Rejection; Transplant, Kidney
Rejection; Transplant, Pancreas
Methylprednisolone
Prednisone
PHASE4
TACKLE-IT is an international, multi-centre, 2x2 factorial, registry-based, single-blind, randomised controlled trial (RCT) that compares the effectiveness and safety of high vs low dose IV MP, and high vs low dose oral prednisone taper as the first-line therapy for acute TCMR in kidney and SPK transplant recipients. This RCT was conceived and developed through extensive consultation and collaboration with our key stakeholders, including transplant recipients with lived experience and the International TCMR Working Group with sponsorship by 4 international transplant societies (The Transplantation Society (TTS), American Society of Transplantation (AST), European Society of Transplantation (ESOT) and Transplant Society of Australia and New Zealand (TSANZ). TACKLE-IT is led by an international multi-disciplinary team of transplant health professionals, clinical trialists, biostatisticians, health economist, social scientist, consumers.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 540 participants |
| Masking : | TRIPLE |
| Masking Description : | As a single-blind study, all participants will be blinded to the allocation of the IV MP treatment comparisons. Other research staff including outcome assessors (such as the pathologists, members of the outcomes adjudication committee, and data analysts) will also be blinded to the IV MP allocation. All investigators, clinicians, participants, research staff, data analysts and outcome assessors will be blinded to the oral prednisone dose allocations. The hospital pharmacy will provide the study oral prednisone drug in a blinded manner. All key stakeholders including the global steering committee, the site investigators, and the trial management committee (TMC) will remain blinded to the individual patient randomization and the aggregate data that may reveal the unblinded outcomes. All researchers responsible for the analysis will remain blinded for the duration of the trial. |
| Primary Purpose : | TREATMENT |
| Official Title : | A Multicenter Randomized Controlled Trial to Treat Acute t Cell Mediated Rejection in Kidney and Kidney-pancreas Transplant Recipients |
| Actual Study Start Date : | 2024-12 |
| Estimated Primary Completion Date : | 2029-12 |
| Estimated Study Completion Date : | 2029-12 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 2 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
John Hunter Hospital
Lambton, New South Wales, Australia, 2305
Not yet recruiting
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Not yet recruiting
The Sydney Children's Hospital Network
Westmead, New South Wales, Australia, 2145
Not yet recruiting
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Not yet recruiting
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 2014
Not yet recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Not yet recruiting
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Not yet recruiting
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Not yet recruiting
Royal Children's Hospital Melbourne
Parkville, Victoria, Australia, 3052
Not yet recruiting
Royal Perth Children's hospital
Nedlands, Western Australia, Australia, 6009
Not yet recruiting
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Not yet recruiting
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Not yet recruiting
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Not yet recruiting
Transplant Manitoba, adult
Winnipeg, Manitoba, Canada, R3A 1R9
Not yet recruiting
Transplant Manitoba, pediatric
Winnipeg, Manitoba, Canada, R3A 1R9
Not yet recruiting
Western University
London, Ontario, Canada, Nata Aqah
Not yet recruiting
University of Toronto
Toronto, Ontario, Canada, M5S 1A1
Not yet recruiting
McGill University
Montréal, Quebec, Canada, H3A 0G4
Not yet recruiting
University of Montreal
Montréal, Quebec, Canada, H3T 1J4
Not yet recruiting
University of Laval
Québec, Quebec, Canada, G1V 0B4
Not yet recruiting
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, Kha dish
Not yet recruiting
Auckland City Hospital
Grafton, Auckland, New Zealand, 1023