Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

November 23, 2015 updated by: E. Steve Woodle, University of Cincinnati

A Single Center, Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients Utilizing a Tacrolimus/Mycophenolate Mofetil Based Maintenance Immunosuppression Protocol

To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppressant therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppression therapy.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati

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 to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Greater than 90 days post transplant.
  • Free from rejection within the last 30 days.
  • Patient with primary diagnosis of AIH will be evaluated on an individual basis.
  • Negative pregnancy test.
  • Practicing an acceptable method of birth control.
  • Capable of providing written informed consent.

Exclusion Criteria:

  • Rejection within the last 30 days.
  • Patients with AIH unable to discontinue corticosteroids.
  • Patients currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation is contraindicated.
  • Known sensitivity or contraindication to tacrolimus or MMF.
  • Kidney, pancreas, islet, heart, lung, or small bowel transplant recipient.
  • Pregnant or lactating.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Immunosuppression
All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short course of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.
Drug: tacrolimus
Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
Other Names:
  • Prograf, FK506
Drug: mycophenolate mofetil
Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
Other Names:
  • MMF, CellCept
Drug: Prednisone
Prednisone is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
Other Names:
  • corticosteriods

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Biopsy Confirmed Acute Rejection at 12 Months.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Survival.
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Post Transplant Corticosteroid Withdrawal
Time Frame: 12 months
The mean days from post transplant corticosteroid withdrawal.
12 months

Collaborators and Investigators

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

Sponsor

University of Cincinnati

Collaborators

Astellas Pharma Inc

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

October 1, 2002

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

January 1, 2008

Study Registration Dates

First Submitted

September 8, 2006

First Submitted That Met QC Criteria

September 8, 2006

First Posted (ESTIMATE)

September 11, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 29, 2015

Last Update Submitted That Met QC Criteria

November 23, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSWD Liver

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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