Study of Enteric-coated Mycophenolate Sodium Maintenance Therapy in Patients With Renal Transplant Receiving Cyclosporine Microemulsion and Steroids,

Inclusion criteria

• Male or female, 18 years of age or older. 2. Recipients of first or secondary cadaver, living related or unrelated donor kidney transplant performed at least 6 month before screening (Visit 1) 3. Patients currently receiving CsA-ME and corticosteroids (at least 5 mg of prednisone equivalents) for at least 3 months prior to Screening, with or without Mycophenolate mofetil or azathioprine.

• Serum creatinine levels < 2.3 mg/dL (=204 µmol/L) at screening and at baseline 5. Stable kidney function, i.e. increase in serum creatinine less than 20% in the last 3 months before screening and at baseline (baseline value as compared to the value obtained at screening) Exclusion Criteria

• Multi-organ recipients (e.g., kidney and pancreas, double kidneys) or previous transplant with any other organ different from kidney
• Patients whit a second transplant who rejected the first one for immunological reasons or because of the relapse of the autoimmune disease which leaded to the end-stage renal failure
• Histological evidence of acute rejection or treatment for acute rejection within the three months prior to Screening, or histological signs or clinical signs of chronic rejection (as significant proteinuria, i.e. > 300 mg/24 hours.
• Patients with maintenance steroid therapy for other diseases (i.e. autoimmune diseases, Lupus).
• 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 (<4,000/mm3), and/or anemia (hemoglobin <9.0 g/dL) prior to Screening visit.
• Patients who have received an investigational drug within two weeks prior to Screening visit.
• 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.
• Any changes of immunosuppressive regimen due to graft malfunction, or any known clinically significant physical and/or laboratory changes in the 2 months prior to Screening visit.
• Known positivity for HIV, HBsAg
• Active viral hepatitis, as shown by liver function tests (AST or ALT) higher than twice the upper limit of normality
• Evidence of drug and/or alcohol abuse Other inclusion/exclusion criteria may apply