CellCept® Dose Adjustment Versus Fixed Dose (Standard Care) in Renal Transplant Recipients

Exclusion Criteria

• •Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method before beginning study drug therapy, during therapy and for 4 months following their last dose of the study drug therapy.
• •Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy.
• •Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
• •Patients with evidence of an active systemic infection requiring the continued use of antibiotics or evidence of an HIV infection, or the presence of a chronic active hepatitis B (HBs-Ag positive) or C.
• •Current or historic Panel Reactive Antibody (PRA) \>50%
• •Positive crossmatch (irrespective of method).
• •Cold ischemia time of the graft of more than 30 hours.
• •Patients who had received an investigational new drug within the last three months at the time of enrollment.
• •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.
• •Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
• •Previous exposure to EC-MPS.