An Open Label Study to Evaluate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Maintenance Renal Transplant Recipients

Exclusion Criteria

• •1. Multi-organ patients (e.g., kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed)
• •2. Evidence of graft rejection or treatment of acute rejection within two months prior to Screening.
• •3. Patients with any known hypersensitivity to EC-MPS or other components of the formulation (e.g., lactose)
• •4. Patients with thrombocytopenia (\<75,000/mm3), with an absolute neutrophil count of \<1,500/mm3 and/or leukocytopenia (\<2,500/mm3), and/or hemoglobin \<6.0 g/dL prior to enrollment.
• •5. Patients who have received an investigational drug within two weeks prior to Screening (i.e., before Day -14 of run-in period).
• •6. Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
• •7. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
• •8. Presence of clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that would interfere with the appropriate conduct of the study.
• •9. Known positive HIV and/or Hepatitis B surface antigen positive.
• •10. Evidence of drug and/or alcohol abuse.