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

A Prospective, Open Label Protocol to Assess the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of kidney transplant recipients.

Inclusion criteria:

• Male and females aged 18 to 75
• Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-ME, with or without corticosteroids, as primary immunosuppression

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 MPA, 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 g/dL at Screening or Baseline.

Other inclusion/exclusion criteria may apply