Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal

A 12-month, Prospective, Randomized, Single Center, Open Label Pilot Study to Evaluate the Safety and Efficacy of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal

To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.

Evaluate the safety and efficacy of Myfortic in combination with tacrolimus and anti-thymocyte globulin in an early corticosteroid withdrawal protocol. Secondary objective is to determine the pharmacokinetic-pharmacodynamic profile of Myfortic in a corticosteroid withdrawal protocol.

Inclusion Criteria:

• Males and females between 18 and 75 years of age.
• Patients who are primary or repeat cadaveric, living unrelated or non-HLA identical living related donor renal transplant recipients.

Exclusion Criteria:

• Patient previously received or is receiving an organ transplant other than kidney.
• Primary or re-transplant from human leukocyte antigen (HLA)-identical living donor.
• Recipient or donor is known to be seropositive for hepatitis C virus (HCV), hepatitis B virus (HBV), or human immunodeficiency virus (HIV).
• Uncontrolled concomitant infection or other unstable medical condition.
• Patients that received an investigational drug in the 30 days prior to transplant.
• Known hypersensitivity to tacrolimus, mycophenolate mofetil (MMF), enteric-coated mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids.
• Receiving chronic steroid therapy at the time of transplant.
• History of malignancy in last 5 years.
• Pregnant or lactating.