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Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
E. Steve Woodle, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00374231
First received: September 8, 2006
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  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 Transplant
 Drug: tacrolimus
Drug: mycophenolate mofetil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Incidence of biopsy confirmed acute rejection at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient and graft survival. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Discontinuation of study drug(s) due to toxicity. [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
  • Time of acute rejection from discontinuation of corticosteroids. [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • Severity of acute rejection. [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • Need for corticosteroid pulse or maintenance therapy for rejection or recurrent disease. [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • Need for an increase in Prograf to treat rejection. [ Time Frame: unspecified ] [ Designated as safety issue: No ]
  • Need for polyclonal or monoclonal antibodies to treat rejection. [ Time Frame: unspecified ] [ Designated as safety issue: No ]
  • Patient weight. [ Time Frame: unspecified ] [ Designated as safety issue: No ]
  • Quantitative bone loss. [ Time Frame: unspecified ] [ Designated as safety issue: No ]
  • Quantitative drug toxicity. [ Time Frame: unspecified ] [ Designated as safety issue: Yes ]
  • Cholesterol and triglyceride levels at 0, 6, 12, and 24 months. [ Time Frame: 0, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Incidence of post transplant DM. [ Time Frame: unspecified ] [ Designated as safety issue: No ]
  • Renal function based on estimated creatinine clearance. [ Time Frame: unspecified ] [ Designated as safety issue: No ]
  • Cardiovascular risk assessment by Framingham criteria at 0, 12, and 24 months. [ Time Frame: 0, 12 and 24 months ] [ Designated as safety issue: Yes ]

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: 1
All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse 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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: E. Steve Woodle, MD, FACS, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00374231     History of Changes
Other Study ID Numbers: CSWD Liver
Study First Received: September 8, 2006
Last Updated: July 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Liver
Transplant
Corticosteroid withdrawal
Tacrolimus
 CellCept
MMF
Mycophenolate mofetil

Additional relevant MeSH terms:
Mycophenolate mofetil
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013