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TACKLE-IT - A multicenter randomized controlled trial to Treat ACute T cell mediated rejection in Kidney and kidney pancreas transpLant rEcIpienTs

Dr Julie Ho
University of Manitoba
Logistics
Virtual
Anticipated time commitment
1 hour meeting, 2-3 times/year
Application deadline
Type of Organ
Kidney
Opportunity Type
Advisory Committee
Theme
T3 - Better Grafts

Transplant is the first choice for most people living with kidney failure, as it improves survival and quality of life compared to dialysis. Improving how long a transplanted kidney lasts is a major priority for patients around the world. One important reason why a kidney transplant fails sooner than expected is T-cell mediated rejection (TCMR).

In TCMR, the patient’s immune system attacks and damages the transplant kidney and can lead to its loss.

The most common therapy for TCMR is “high-dose steroids,” but the international community does not know or agree on the correct dose due to a lack of data, so different centers use different doses, which can result in too much or too little steroids.

  • Too much steroids can cause serious side effects, such as an increased risk of infections, diabetes, high blood pressure, high cholesterol and bone complications, as well as limiting growth in kids with a kidney transplant.
  • Too little steroids can fail to stop rejection.
  • Our research has shown that 39-50% of patients treated with high dose steroids do not get remission which can lead to an increased risk of transplant loss and death.

Our goal is to improve overall TCMR care to lengthen transplant and patient survival.

This project will perform an international, multicenter, randomized controlled trial to define the standard-of-care therapy for TCMR and resolve a decades-long unanswered question, ‘What is the minimally acceptable, safe and effective steroid dose for the treatment of acute TCMR in kidney and simultaneous kidney pancreas transplant recipients?’

This data will inform clinical practice around the world and be used to help design the next stage of trials to test new drugs for TCMR. Ultimately our goal is to find the optimal dose of steroids that achieves TCMR remission while minimizing their side effects, to improve patient and transplant survival in children and adults living with kidney failure.

Experience required

We are looking for 2 Canadian kidney or simultaneous-kidney pancreas transplant patients who are: • Adults (aged 18 years and above), preferably with lived experience of childhood CKD • Caregivers with lived experience of caring for a child, adolescent, or young adult with CKD.

Potential roles for PFD Partners

  • 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.

Reimbursement

$50/hour will be provided in gift certificates (e.g. such as grocery store, Tim Horton's, type to be determined in collaboration with patient partners).

How to get in touch

Name
Chandana Guha
Job title
Post-doctoral research fellow and caregiver partner
Email

Please see our TACKLE-IT website at https://tackleit.com.au/ for more information.