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30/09/25
An international clinical trial co-led by researchers at the University of Sydney has received a major funding boost, with the Canadian arm of the TACKLE-IT trial awarded $2.76 million CAD from the Canadian Institutes of Health Research (CIHR).
The funding was secured through CIHR’s highly competitive Project Grant Program, which supports research with the greatest potential to advance health outcomes and knowledge. The Canadian component of the study is led by Professor Julie Ho at the University of Manitoba.
The TACKLE-IT trial is a global, multicentre, randomised controlled study focused on improving outcomes for kidney transplant recipients by identifying the optimal steroid dose for treating T-cell mediated rejection (TCMR)—a leading cause of transplant failure. The Australian arm of the study is led by Professor Germaine Wong at the University of Sydney and is coordinated by the NHMRC Clinical Trials Centre.
“Setting the global standard of care for T cell mediated rejection treatment through this international research partnership is a crucial first step towards improving patient outcomes and lays the groundwork for further evaluation of novel treatments. After kidney transplantation, patients can experience many side effects which directly impacts their quality of life. Identifying the least amount of steroid possible to minimize these side effects provides medical professionals with best practices for treating rejection to offer better patient outcomes,” Professor Julie Ho, Canadian Chief Investigator, TACKLE-IT.
“TACKLE-IT is a commitment to improving the lives of kidney transplant recipients. By finding the safest and most effective steroid dosing strategy for treating acute rejection, we are aiming to reduce the side effects, protect the transplant, and give every recipient the best chance at long-term kidney graft survival,” Professor Germaine Wong, Australian Chief Investigator, TACKLE-IT.
Kidney transplantation is the preferred treatment for people living with kidney failure, offering improved survival and quality of life compared to dialysis. However, TCMR remains a major challenge. Current steroid treatments vary widely between centres and often fail to achieve remission, with significant risks of under- or over-treatment.
The TACKLE-IT trial aims to address this gap by determining the minimally acceptable, safe and effective steroid dose for treating acute TCMR in both adult and paediatric transplant recipients.
This study has the potential to significantly improve long-term outcomes for kidney and simultaneous pancreas-kidney (SPK) transplant recipients by reducing rejection-related complications and enhancing quality of life. It may also inform future clinical guidelines for steroid use in transplant medicine, helping to standardise care and reduce treatment-related risks.
The data generated will inform global clinical practice and lay the groundwork for future trials testing new therapies for TCMR, with the ultimate goal of improving transplant longevity and patient survival.
The Canadian arm of this trial will be funded by the Canadian Institutes of Health Research - University of Manitoba is the Canadian study sponsor. The Australian arm of this trial is funded by the National Health and Medical Research Council (NHMRC) categorised under Medical Research Future Fund (MRFF) - 2023 International Clinical Trial Collaborations (APP 2027692). University of Sydney is Sponsor.