This is a study for patients who have received a whole liver transplant. Calcineurin inhibitors are drugs often used to prevent organ rejection, but may cause damage to the kidneys with long term use. This study will look at how the two different drug combinations work in preventing rejection of the transplanted liver while also maintaining kidney function. Patients who meet the requirements of the study will be randomly (by chance) assigned to two groups. One group will receive mycophenolate mofetil combined with sirolimus. The other group will receive mycophenolate mofetil and a calcineurin inhibitor (tacrolimus or cyclosporine). The study will last 12 months from time of transplant. Patients will be followed for the 12 months; there will be 7 visits during this trial and a follow-up visit at 24 months.

Condition	Intervention	Phase
Liver Diseases Liver Transplantation	Drug: mycophenolate mofetil	Phase IV

Ages Eligible for Study:  18 Years   -   74 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Male or female 18 to 74 years of age
• Have received one liver transplant from a deceased donor
• Patients who have been on CellCept plus tacrolimus or cyclosporine from the time of transplant at dosages (amount of drug given) required in this study
• Female patients who have a negative blood test to determine pregnancy within 7 days before start of study.
• Patients who understand the purpose and risks of the study and are willing and able to give written and informed consent
• Patients who are willing and able to follow the requirements of the study

Exclusion Criteria:

• Received liver from a living donor
• Received a split (partial not whole) liver
• Received more than one transplant
• Female patients who are pregnant or breast-feeding
• Females who can become pregnant who do not agree to use 2 reliable forms of birth control before beginning treatment, during treatment and for 12 weeks after stopping treatment even if there is a history of infertility.
• Received sirolimus before start of study
• Required dialysis for more than 14 days from transplant until assignment of treatment group
• Patients with severe gastrointestinal disorders
• Patients with certain abnormal laboratory test results
• Patients with history of cancer in the last 5 years. An exception is patients with liver cancer and patients who had successful treatment for melanoma, a type of skin cancer.

Please refer to this study by ClinicalTrials.gov identifier  NCT00118742

Please reference Study ID Number: RLI-ML18423      973-235-5000 
or      800-526-6367 (FOR US ONLY) 

Florida
      Tampa,  Florida,  33606,  United States
Michigan
      Detroit,  Michigan,  48202,  United States
New Jersey
      Newark,  New Jersey,  07107,  United States
New York
      New York,  New York,  10029,  United States
Pennsylvania
      Philadelphia,  Pennsylvania,  19104,  United States

Study ID Numbers:  ML18423
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 11, 2005
ClinicalTrials.gov Identifier:  NCT00118742
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26