Actively Recruiting
TACKLE-IT Trial - Treat Acute T Cell Rejection With Evidence and Confidence in Kidney Transplant Recipients
Led by University of Sydney · Updated on 2026-05-06
540
Participants Needed
25
Research Sites
220 weeks
Total Duration
On this page
Sponsors
U
University of Sydney
Lead Sponsor
U
University of Manitoba
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TACKLE-IT Trial - Treat Acute T Cell Rejection With Evidence and Confidence in Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants or their legal guardian must be able to understand and provide written informed consent
- Willingness to comply with all study procedures and be available for the study duration
- Equal access for all ethnic and gender groups
- Children aged 2 years and older and adults with biopsy-proven acute T cell mediated rejection (TCMR) after kidney or simultaneous pancreas-kidney transplant, with at least Banff borderline (minimum i1 score), clinical or subclinical
You will not qualify if you...
- Mixed rejection
- Active or chronic active antibody-mediated rejection (ABMR)
- Chronic active TCMR (except when concurrent with acute TCMR)
- Isolated v1 lesion without inflammation
- Concurrent renal diseases like recurrent glomerulonephritis or polyomavirus nephropathy
- Active malignancies or infections that prevent increasing immunosuppression
- Use of other immunomodulatory agents such as Rituximab, Anti-TNF monoclonal antibody, Belatacept, Abatacept, Janus kinase inhibitors, Eculizumab, Pegcetacoplan
- Participation in other interventional drug trials
- Use of other investigational agents
- Inability to follow the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
John Hunter Hospital
Lambton, New South Wales, Australia, 2305
Not Yet Recruiting
2
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Not Yet Recruiting
3
The Sydney Children's Hospital Network
Westmead, New South Wales, Australia, 2145
Not Yet Recruiting
4
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
5
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 2014
Actively Recruiting
6
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Not Yet Recruiting
7
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Not Yet Recruiting
8
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Not Yet Recruiting
9
Royal Perth Children's hospital
Nedlands, Western Australia, Australia, 6009
Not Yet Recruiting
10
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Not Yet Recruiting
11
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Not Yet Recruiting
12
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Not Yet Recruiting
13
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
Not Yet Recruiting
14
Transplant Manitoba, adult
Winnipeg, Manitoba, Canada, R3A 1R9
Not Yet Recruiting
15
Transplant Manitoba, pediatric
Winnipeg, Manitoba, Canada, R3A 1R9
Not Yet Recruiting
16
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 4R2
Not Yet Recruiting
17
Western University
London, Ontario, Canada, N6A 3K7
Not Yet Recruiting
18
University of Toronto - St Michael Hospital
Toronto, Ontario, Canada, M5B 1W8
Not Yet Recruiting
19
University of Toronto - Hospital for Sick Kids
Toronto, Ontario, Canada, M5G 1E8
Not Yet Recruiting
20
University of Toronto
Toronto, Ontario, Canada, M5S 1A1
Not Yet Recruiting
21
McGill University
Montreal, Quebec, Canada, H3A 0G4
Not Yet Recruiting
22
University of Montreal
Montreal, Quebec, Canada, H3T 1J4
Not Yet Recruiting
23
University of Laval
Québec, Quebec, Canada, G1V 0B4
Not Yet Recruiting
24
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 5A2
Not Yet Recruiting
25
Auckland City Hospital
Grafton, Auckland, New Zealand, 1023
Not Yet Recruiting
Research Team
N
NHMRC Clinical Trials Centre THE UNIVERSITY OF SYDNEY
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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