Mycophenolate Mofetil Immunosuppression Without/With Reduced Dose Calcineurin Inhibitor Long After Liver Transplantation

Completed · Phase 4

Conditions studied: Liver Disease

In brief

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 transplantation, in an attempt to reduce the potential side effects from using cyclosporine or tacrolimus.

Key facts

Study ID

NCT00206076

Run by

Albert Einstein Healthcare Network

People needed

19

Starts

2006-08-01

Expected to finish

2009-06-01

Last updated by the study team

2013-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Kentucky at Lexington — Lexington, Kentucky, United States
• Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States
• Texas Transplant Institute — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.