Expression of interest to be a member of the Consumer Advisory Board

What is the TACKLE IT Trial?

This is a multicentre randomized controlled trial to treat T cell mediated rejection (TCMR).

What is the problem?

Kidney failure occurs when the kidneys lose their ability to filter waste and excess fluids from the blood effectively. In severe cases, kidney failure may necessitate a kidney transplant, where a healthy kidney from a donor is surgically placed into the recipient’s body. Sometimes some patients may need a kidney and a pancreas transplant. Simultaneous pancreas-kidney (SPK) transplant is a procedure where a patient with type 1 diabetes and kidney failure receives both a kidney and a pancreas from the same donor at the same time, eliminating the need for insulin therapy and dialysis.

ll mediated rejection (TCMR) is a problem for long-term kidney function and transplant survival. If not fully treated, it can cause ongoing damage and a loss of the transplant. Following kidney or simultaneous kidney-pancreas (SPK) transplants, around 30% of recipients may encounter acute T-cell mediated rejection (TCMR) within the initial year that can result in loss of the transplant and a return to dialysis for some patients. High doses of steroids can cause serious side effects like infections, weight gain, diabetes, bone problems and thin bones. Therefore, finding the right steroid dose that works well and is safe is crucial for managing TCMR in kidney and SPK transplants.

The TACKLE-IT trial aims to find the best steroid dose for treating acute TCMR and will be conducted at 24 sites across Canada, Australia, and New Zealand. Children (aged 2+ years) and all adults who have received a kidney or SPK transplant and have been diagnosed with acute TCMR through a biopsy will be eligible to participate in the study.

We are aiming to recruit 540 patients from November 2024 Upon enrolment, patients will be assigned to groups to receive intravenous methyl prednisone followed by oral prednisone in varying doses to treat rejection. By comparing the responses to treatment of the various groups of patients, the study will try to understand the right dose of steroids to manage TCMR and improve long-term transplant success. The recruitment period is 3 years and duration of the study is 60 months.

Why do we need a Consumer Advisory Board (CAB)?
The researchers want to make sure that the study is designed in a way that is meaningful to patients and carers and focuses on outcomes that are important to them. The CAB will help recruitment by ensuring the study documents that are provided to patients are clear and useful and provide input on the interpretation and sharing of study findings with the kidney healthcare community. Consumer engagement in research is expected by the National Health and Medical Research Council, funder of this research.

What level of engagement is involved?

• A half-day onboarding and training session once the consumer advisory board is formed.
• A one-hour meeting 2-3 times a year depending on the need for input from the Board, via tele/videoconference.
• Providing feedback on study documents, procedures and findings via email as needed.
• Reimbursements for attending meetings as per Health Consumers NSW recommendations.

Who are we looking for?
5-6 consumers with either kidney or SPK transplant recipients who are:

• Adults (aged 18 years and above) with preferably with lived experience of childhood CKD
• Caregivers with lived experience of caring for a child, adolescent, or young adult with CKD.

When does it all start?
We are aiming to commence the CAB activities from July 2024.

Will members be acknowledged for their input?

With permission, members will be acknowledged on the TACKLE IT website and other study documents.

How do I become involved?
 Please contact:

Chandana Guha (Research Fellow, Centre for Kidney Research)

E: chandana.guha@sydney.edu.au