NCT03315052

Budesonide for Immunosuppression After Liver Transplantation to Reduce Side Effects

Budesonide in Liver Transplantation

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Acute Cellular Graft Rejection
• Liver Transplant Rejection

Interventions

Type	Name	Description
DRUG	Budesonide	Oral steroid with high first-pass metabolism in liver
DRUG	Tacrolimus（FK506）	Calcineurin immunosuppressant
DRUG	Mycophenolate Mofetil	Immunosupressant
DRUG	Prednisone	Immunosuppresant

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-01-01
• Completion: 2022-01-01
• First posted: 2017-10-19
• Last updated: 2019-09-23

Regulatory

• FDA-regulated drug study