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December 11, 2018

Project title: POSITIVE (Personalising Immunosuppression to Improve Efficacy)

Principle Investigators: Seema Mital/ Upton Allen/ This email address is being protected from spambots. You need JavaScript enabled to view it.

Is the study funded?           Yes     

Is the study open for recruitment?        No      

Brief description of project:
The overall objective of this project is to analyze physiological factors that impact immune response and effect of immunosuppression across different pediatric age groups, to develop age-appropriate medical and health care strategies that can improve graft survival and reduce complications in a pediatric and young adult population. There are 3 primary aims of this study:
 
Aim 1: Develop age-appropriate calcineurin-inhibitor (CNI) dosing for pediatric SOT & HSCT patients
 
Aim 2: Develop risk prediction tools based on viral-host interactions that predispose young SOT & HSCT patients to Epstein-Barr virus disorders/post-transplant lymphoproliferative disorder (EBV disorders/PTLD)
 
Aim 3: Develop health care systems strategies to enhance medication adherence in adolescents and young adults
This aim has two primary objectives:
Objective 1: To characterize differences between Canadian solid organ transplant programs in potentially modifiable meso- and macro-level systems factors.
Objective 2: To identify potentially modifiable meso- and macro-level factors that are determinants of adherence, adjusting for potential confounders.
Inclusion criteria:
Aim 1:
  • Patients <18 years old
  • Listed for or recipient of SOT
  • Planned immunosuppression with oral or enteral tacrolimus post-transplant
Aim 2:
  • SOT recipients <18 years old within first year post transplant
  • Donor-transmitted EBV i.e. Donor EBV-seropositive, recipient-EBV seronegative (D+R-), or donor and recipient seronegative (D-R-) at time of transplant
  • New onset primary EBV from non-transplant acquisition during one year follow-up post transplant
  • New onset PTLD in new or prevalent EBV-positive transplant patients.
  • Single organ kidney, liver, and heart recipients aged 14-25 years
  • At least 3 months post transplant
  • Intact graft function (defined as no need for dialysis for kidney recipients, and not currently listed for re-transplant for any organ type)
  • Receiving maintenance immunosuppression
Aim 3:
  • Single organ kidney, liver, and heart recipients aged 14-25 years
  • At least 3 months post transplant
  • Intact graft function (defined as no need for dialysis for kidney recipients, and not currently listed for re-transplant for any organ type)
  • Receiving maintenance immunosuppression
Exclusion criteria:
  • Patients listed for re-transplantation or multiple organ transplantation.
  • Individuals with significant neuro-cognitive disabilities limiting their ability to understand and participate in their own care (as judged by the parents in the healthcare team) (Aim 3)
  • Patients unable to communicate comfortably in English or French (Aim 3)
  • Patients who are transferred to a non-participating adult center for follow-up during the course of the study will be permitted to participate until the transfer occurs, and will then be withdrawn (Aim 3)

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