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

Inclusion criteria

• Males and females aged between 18 and 80 years.
• Recipients of first or secondary cadaveric, living related or unrelated donor kidney transplant at least 6 months after transplantation.
• Patients currently receiving CsA-ME with MMF , with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months prior to Screening.
• Patients receiving MMF at reduced dose prior to study entry
• Patients in a stable condition in terms of graft function (serum creatinine not above 2.3 mg/dL (=204 µmol/L) at screening and at baseline, or not increased by more than 20% at baseline compared to values obtained at screening), no change of immunosuppressive regimen due to graft malfunction, and any known clinically significant physical and/or laboratory changes for at least 2 months prior to enrollment.
• Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to or at screening. Effective contraception must be used during the trial, and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
• Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

Exclusion criteria

• Multi-organ patients (e.g., kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed)
• Evidence of graft rejection or treatment of acute rejection within two months prior to Screening.
• Patients with any known hypersensitivity to EC-MPS or other components of the formulation (e.g., lactose)
• 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.
• Patients who have received an investigational drug within two weeks prior to Screening (i.e., before Day -14 of run-in period).
• Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
• 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
• 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.
• Known positive HIV and/or Hepatitis B surface antigen positive.
• Evidence of drug and/or alcohol abuse.