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

September 19, 2019 updated by: Montefiore Medical Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Budesonide treatment arm
Patients treated with budesonide in place of prednisone as part of immunosuppressive regimen
Drug: Budesonide
Oral steroid with high first-pass metabolism in liver
Other Names:
  • Enterocort
Drug: Tacrolimus（FK506）
Calcineurin immunosuppressant
Other Names:
  • Prograf
Drug: Mycophenolate Mofetil
Immunosupressant
Other Names:
  • Cellcept
Active Comparator: Standard immunosuppression arm
Patients treated with standard immunosuppression after liver transplant
Drug: Tacrolimus（FK506）
Calcineurin immunosuppressant
Other Names:
  • Prograf
Drug: Mycophenolate Mofetil
Immunosupressant
Other Names:
  • Cellcept
Drug: Prednisone
Immunosuppresant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute cellular rejection (ACR)
Time Frame: 12 months
Incidence of ACR in budesonide treatment arm as compared to standard treatment arm
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tacrolimus trough levels
Time Frame: 12 months
Cumulative average trough level of tacrolimus in budesonide and standard treatment arms
12 months
Diabetes
Time Frame: 12 months
Incidence of diabetes in in budesonide and standard treatment arms
12 months
Worsening kidney function
Time Frame: 12 months
Incidence of worsening kidney function in budesonide and standard treatment arms
12 months
Hyptertension
Time Frame: 12 months
Incidence of hypertension in in budesonide and standard treatment arms
12 months
Graft survival
Time Frame: 12 months
Graft survival in budesonide and standard treatment arms
12 months
Patient survival
Time Frame: 12 months
Patient survival in budesonide and standard treatment arms
12 months
Infection
Time Frame: 12 months
Incidence of infection in budesonide and standard treatment arms
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2019

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

October 13, 2017

First Submitted That Met QC Criteria

October 16, 2017

First Posted (Actual)

October 19, 2017

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-7959

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Annonymous IPD will be shared in the event that the study protocol is approved at other transplanting institutions who then collaborate in this study. IPD will include standard clinical and laboratory data monitored after liver transplantation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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