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Completed

NCT Number: NCT00374231

Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

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.

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Key information

Conditions

Liver Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tacrolimus

Drug

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

Mycophenolate mofetil

Drug

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

Prednisone

Drug

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

Primary outcomes

  1. Incidence of Biopsy Confirmed Acute Rejection at 12 Months.

    Time frame: 12 months

Secondary outcomes

  1. Patient Survival.

    Time frame: 12 months

Other outcomes

  1. Time Post Transplant Corticosteroid Withdrawal

    Time frame: 12 months

    The mean days from post transplant corticosteroid withdrawal.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • Astellas Pharma Inc

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Sep 11, 2006
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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