Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

Inclusion criteria

• Males and females aged 18 to 75 years.
• Recipients of living related kidney transplant, treated with cyclosporine, with or without corticosteroids, as primary immunosuppression.
• 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 recipients (e.g. kidney and pancreas) or previous transplant with any organ, other than kidney.
• Patients with any known hypersensitivity to other components of the formulation (e.g. lactose).
• Patients with low platelet count (< 75,000/mm3), with an absolute neutrophil count of < 1,500/mm3, and/or leukocytopenia (< 2,500/mm3), and/or hemoglobin < 6 g/dL at screening or baseline.
• Patients who have received an investigational drug within four weeks prior to study entry.
• 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.

Additional protocol-defined inclusion/exclusion criteria may apply