We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00374231
First Posted: September 11, 2006
Last Update Posted: December 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
E. Steve Woodle, University of Cincinnati
  Purpose
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.

Condition Intervention Phase
Liver Transplantation Drug: tacrolimus Drug: mycophenolate mofetil Drug: Prednisone Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center, Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients Utilizing a Tacrolimus/Mycophenolate Mofetil Based Maintenance Immunosuppression Protocol

Resource links provided by NLM:


Further study details as provided by E. Steve Woodle, University of Cincinnati:

Primary Outcome Measures:
  • Incidence of Biopsy Confirmed Acute Rejection at 12 Months. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Patient Survival. [ Time Frame: 12 months ]

Other Outcome Measures:
  • Time Post Transplant Corticosteroid Withdrawal [ Time Frame: 12 months ]
    The mean days from post transplant corticosteroid withdrawal.


Enrollment: 40
Study Start Date: October 2002
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: corticosteriods

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00374231


Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Astellas Pharma Inc
Investigators
Principal Investigator: Steve Woodle, MD University of Cincinnati
  More Information

Responsible Party: E. Steve Woodle, MD, FACS, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00374231     History of Changes
Other Study ID Numbers: CSWD Liver
First Submitted: September 8, 2006
First Posted: September 11, 2006
Results First Submitted: December 19, 2013
Results First Posted: December 29, 2015
Last Update Posted: December 29, 2015
Last Verified: November 2015

Keywords provided by E. Steve Woodle, University of Cincinnati:
Liver
Transplant
Corticosteroid withdrawal
Tacrolimus
CellCept
MMF
Mycophenolate mofetil

Additional relevant MeSH terms:
Prednisone
Mycophenolic Acid
Tacrolimus
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents