Budesonide for Immunosuppression After Liver Transplantation to Reduce Side Effects (BILT)

Montefiore Medicine Academic Health System

Status and phase: Withdrawn; Phase 4

Conditions: Liver Transplant Rejection; Acute Cellular Graft Rejection

Treatments: Drug: Budesonide; Drug: Prednisone; Drug: Tacrolimus（FK506）; Drug: Mycophenolate Mofetil

Study type: Interventional

Funder types: Other

Identifiers

NCT03315052

2017-7959

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Budesonide treatment arm

Experimental group

Description:

Patients treated with budesonide in place of prednisone as part of immunosuppressive regimen

Treatment:

Drug: Mycophenolate Mofetil

Drug: Tacrolimus（FK506）

Drug: Budesonide

Standard immunosuppression arm

Active Comparator group

Description:

Patients treated with standard immunosuppression after liver transplant

Treatment:

Drug: Mycophenolate Mofetil

Drug: Tacrolimus（FK506）

Drug: Prednisone