Status:
COMPLETED
Mycophenolate Mofetil Immunosuppression Without/With Reduced Dose Calcineurin Inhibitor Long After Liver Transplantation
Lead Sponsor:
Albert Einstein Healthcare Network
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Liver Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to assess the safety and efficacy of mycophenolate mofetil alone, or with reduced dose cyclosporine (CsA) or tacrolimus, for immunosuppression long-term after liver transpl...
Detailed Description
Most liver transplant recipients receive an immunosuppressive drug regimen that contains either cyclosporine or tacrolimus. Although these drugs have revolutionized transplantation, in many patients t...
Eligibility Criteria
Inclusion
- Male or female 18 years of age or older (females who can become pregnant must use two acceptable methods of birth control while taking mycophenolate mofetil)
- Orthotopic liver transplant more than one year prior to enrollment
- Using calcineurin inhibitor to prevent rejection at time of screening
- Patients must be willing to provide informed consent and abide by the requirements of the study
Exclusion
- Liver disease may not have been secondary to an autoimmune cause, including:
- autoimmune hepatitis,
- primary sclerosing cholangitis,
- primary biliary cirrhosis
- Patients who have had:
- more than one prior episode of rejection,
- rejection within the past six months,
- any corticosteroid resistant rejection
- Patients with a tacrolimus trough level of greater than 7 ng/ml within 90 days prior to enrollment
- Patients with a cyclosporine trough level greater than 225 ng/ml within 90 days prior to enrollment
- Patients taking more the 5 mg per day of prednisone within 90 days prior to enrollment
- Patients taking any prednisone within 30 days of enrollment
- Allograft dysfunction within 6 months of enrollment, including ALT and/or total bilirubin greater than 2x normal, and/or biopsy proven hepatitis C virus (HCV) with fibrosis greater than stage II
- White blood cell count less than 2,500 or platelet count less than 50,000 within 60 days of enrollment
- MPA AUC threshold: Patients are not eligible for the study if they do not attain the threshold value MPA AUC (\>30 mg\*h/L if on CsA, \>40 mg\*h/L if on tacrolimus) after 50% calcineurin inhibitor reduction, measured using a 3-sample estimate (trough, 30-min, 120-min)
- Patients who have had a previous transplant of organ(s) other than liver
- Patients who received a liver from a hepatitis C positive donor
- Patients who received a liver from a living donor
- Patients with any technical complication requiring intervention within the three months prior to screening
- Current infection requiring treatment
- History of post transplant lymphoproliferative disorder
- History of malignancy other than non-melanoma skin cancer or Stage 1-2 hepatoma
- Active or unhealed duodenal ulcer
- Concomitant treatment with rapamycin and/or interferon
- Known allergy or sensitivity to CellCept® or any of its components
- Unable or unwilling to comply with the protocol requirements or considered by the investigator(s) to be unfit for the study
- Participation in a clinical trial within 30 days prior to study entry or prior enrollment in any CellCept® clinical trial
- Pregnant or breastfeeding woman
- Diabetes with known, clinically significant gastroparesis
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00206076
Start Date
August 1 2006
End Date
June 1 2009
Last Update
August 2 2013
Active Locations (3)
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1
University of Kentucky at Lexington
Lexington, Kentucky, United States
2
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
3
Texas Transplant Institute
San Antonio, Texas, United States