Liver Transplant Rejection Clinical Trial
Official title:
Budesonide in Liver Transplantation
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.
This study will be a randomized, open-label non-inferiority trial to assess the efficacy,
safety and tolerability of budesonide in combination with low-dose FK and standard-dose MMF
as post-OLT ISP in comparison to standard ISP (S-ISP). Subjects will include OLT patients age
18 years and older receiving their first single-organ living- or deceased-donor liver
transplant. Subjects must have post-operative recovery of graft function and be able to take
oral medications before beginning treatment according to the study protocol.
Subjects will be randomized to receive either (1) investigational oral ISP including
budesonide 9mg by mouth in three daily divided doses, FK with an initial target trough level
of no greater than 5-6ng/mL, and MMF (I-ISP); or (2) S-ISP including prednisone, calcineurin
antagonist, and MMF. After randomization, subjects will be followed for a total of 52 weeks
and assessed for adequacy of graft function, and complications of therapy, particularly ACR
;
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