Budesonide for Liver Transplant Immune Suppression
Status:
Completed
Trial end date:
2019-12-31
Target enrollment:
Participant gender:
Summary
This is a pilot study that investigates the efficacy and safety of budesonide as an immune
suppressing agent for liver transplant recipients in the early post-transplant period.
The primary end-point is rates of acute cellular rejection within first 24 weeks post-liver
transplant. Secondary end points include rates of new onset diabetes after transplant and
safety of budesonide.
The study is structured as a prospective clinical trial. After receiving 4 days of
intravenous corticosteroids on liver transplant post-operative days 0 through 3, subjects
will be started on standard immunosuppression plus enteric coated budesonide (study drug) in
place of standard immune suppression plus prednisone (standard of care). Study drug will be
tapered over 12 weeks in accordance with the existing standard of care immune suppression
protocol. Subjects will be followed in outpatient transplant clinic for 24 weeks. The purpose
of the study is to conduct a pilot study to generate rates and effect size that can be used
in a subsequent equivalent trial. A total of 20 subjects will be enrolled to receive the
standard immunosuppression plus budesonide and their outcomes will be compared to 20 controls
receiving standard immunosuppression plus prednisone (standard of care). The use of controls
is to generate rate and variability that can be compared with the rate obtained from patients
that receive study drug by examining the 95% confidence band.