A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Kidney Transplant Recipients

Inclusion criteria

• Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
• Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living kidney transplant
• Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure
• Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization

Exclusion criteria

• Patient has previously received or is receiving an organ transplant other than a kidney
• Patient has received a kidney transplant from a non-heart beating donor
• Patient has received an ABO incompatible donor kidney
• Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
• Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
• Patient has significant liver disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
• Patient has an uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives
• Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
• Patient is receiving everolimus or enteric coated mycophenolic acid at any time during the study
• Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil or corticosteroids
• Patient is pregnant or lactating
• Patient is unlikely to comply with the visits scheduled in the protocol
• Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator