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A Multicenter Randomized Controlled Trial to Treat Acute T Cell Mediated Rejection in Kidney and Kidney-Pancreas Transplant Recipients
Sponsor: University of Sydney
Summary
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.
Official title: A Multicenter Randomized Controlled Trial to Treat Acute t Cell Mediated Rejection in Kidney and Kidney-pancreas Transplant Recipients
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
540
Start Date
2026-03-13
Completion Date
2030-06
Last Updated
2026-08-31
Healthy Volunteers
No
Interventions
Methylprednisolone
IV Methylprednisolone
Prednisone
Oral prednisone augmentation
Locations (30)
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