NCT00374231

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
8 years until next milestone

Results Posted

Study results publicly available

December 29, 2015

Completed
Last Updated

December 29, 2015

Status Verified

November 1, 2015

Enrollment Period

5.3 years

First QC Date

September 8, 2006

Results QC Date

December 19, 2013

Last Update Submit

November 23, 2015

Conditions

Liver Transplantation

Keywords

LiverTransplantCorticosteroid withdrawalTacrolimusCellCeptMMFMycophenolate mofetil

Outcome Measures

Primary Outcomes (1)

  • Incidence of Biopsy Confirmed Acute Rejection at 12 Months.

    12 months

Secondary Outcomes (1)

  • Patient Survival.

    12 months

Other Outcomes (1)

  • Time Post Transplant Corticosteroid Withdrawal

    12 months

Study Arms (1)

Immunosuppression

EXPERIMENTAL

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: tacrolimusDrug: mycophenolate mofetilDrug: Prednisone

Interventions

tacrolimusDRUG

Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.

Also known as: Prograf, FK506
Immunosuppression
mycophenolate mofetilDRUG

Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.

Also known as: MMF, CellCept
Immunosuppression
PrednisoneDRUG

Prednisone is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.

Also known as: corticosteriods
Immunosuppression

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Interventions

TacrolimusMycophenolic AcidPrednisone

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
E. Steve Woodle, MD
Organization
University of Cincinnati
woodlees@uc.edu
(513) 558-6001

Study Officials

  • Steve Woodle, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FACS

Study Record Dates

First Submitted

September 8, 2006

First Posted

September 11, 2006

Study Start

October 1, 2002

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

December 29, 2015

Results First Posted

December 29, 2015

Record last verified: 2015-11

Locations

US(1)