A Pilot Trial of Pediatric Liver Transplantation Without Steroids

A Randomized Pilot Trial of a Steroid-free Immunosuppressant Regimen in Pediatric Liver Transplantation

Objective:

The overall objective is to investigate whether a steroid free immunosuppressive regimen is as safe and effective as a steroid containing regimen following pediatric liver transplantation and whether it promotes tolerance.

3.2 Research question

Is it possible to avoid the use of corticosteroids in pediatric liver transplantation?

3.3 Trial objectives

This will be a pilot study to

i) investigate to what degree a steroid free immunosuppressive regimen is as safe and effective as a steroid containing regimen following pediatric liver transplantation

ii) investigate the effect of a steroid free immunosuppressive regimen on lymphocyte function and donor-specific immune responsiveness following pediatric liver transplantation

iii) investigate the effect of a steroid free immunosuppressive regimen on expression of tissue markers of tolerance following pediatric liver transplantation

It is hoped that this pilot study will be used to develop a definitive multicentre study of a steroid free regimen.

Inclusion Criteria:

• Children undergoing primary isolated hepatic transplantation.
• Age <=18 years
• Ability to provide informed consent

Exclusion Criteria:

• Children undergoing retransplantation.
• Transplantation for Intestinal failure associated liver disease.
• Multi-organ transplantation.
• Transplantation for autoimmune liver disease.
• Transplantation for extra hepatic malignancy.
• Pre-existing need for oral steroids, or high dose inhaled steroids sufficient to require a steroid warning card.