Overview

Budesonide for Immunosuppression After Liver Transplantation to Reduce Side Effects

Status:
Withdrawn

Trial end date:
2022-01-01

Target enrollment:
0

Participant gender:
All

Summary

Our hypothesis is that budesonide will provide effective hepatic ISP that will replace prednisone and allow lower systemic drug levels of FK, thus reducing the steroid- and calcineurin-associated complications often observed in the OLT population. This study is intended to investigate the therapeutic potential of this ISP combination.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Montefiore Medical Center

Treatments:

Budesonide
Mycophenolic Acid
Prednisone
Tacrolimus

Criteria

Inclusion Criteria: Adult patients age 18 years or older who undergo initial single-organ
living- or deceased-donor liver-transplant surgery. Research participants are required to
have satisfactory post-operative recovery of graft function and no post-operative
renal-replacement therapy prior to starting medication according to protocol. They must
also be able to take oral medications.

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Exclusion Criteria: Patients will be excluded from the study if they are: (1) undergoing
retransplantation; (2) have fulminant hepatic failure as an indication for liver
transplantation; (3) have surgical complication(s) potentially affecting post-operative
graft function (i.e., hepatic artery thrombosis); or have delayed initial recovery of graft
function (primary non-function) requiring non-standard induction therapy. Furthermore,
patients with a contraindication to budesonide (i.e., hypersensitivity) will not be
included in the study

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