RecruitingPhase 3NCT06474273

TACKLE-IT Trial - Treat Acute T Cell Rejection With Evidence and Confidence in Kidney Transplant Recipients

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


Sponsor

University of Sydney

Enrollment

540 participants

Start Date

Mar 13, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Methylprednisolone and a drug called Prednisone for people with rejection; transplant, kidney and rejection; transplant, pancreas. The study is currently recruiting participants at 25 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethylprednisolone

IV Methylprednisolone

DRUGPrednisone

Oral prednisone augmentation


Locations(25)

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

Royal Perth Children's hospital

Nedlands, Western Australia, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

University of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Transplant Manitoba, adult

Winnipeg, Manitoba, Canada

Transplant Manitoba, pediatric

Winnipeg, Manitoba, Canada

Dalhousie University

Halifax, Nova Scotia, Canada

Western University

London, Ontario, Canada

University of Toronto - St Michael Hospital

Toronto, Ontario, Canada

University of Toronto - Hospital for Sick Kids

Toronto, Ontario, Canada

University of Toronto

Toronto, Ontario, Canada

McGill University

Montreal, Quebec, Canada

University of Montreal

Montreal, Quebec, Canada

University of Laval

Québec, Quebec, Canada

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Auckland City Hospital

Grafton, Auckland, New Zealand

View Full Details on ClinicalTrials.gov

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NCT06474273