A Randomized, Open-label Study of the Achievement of a Mycophenolic Acid Therapeutic Window During Treatment With 2 Dosing Regimens of Oral CellCept Administered as a Component of Standard Immunosuppressive Therapy in Patients With Kidney Transplants
- adult patients >=18 years of age;
- recipients of a primary kidney transplant.
- positive for HIV-1, human T-cell leukemia/lymphoma virus-1 (HTLV-1), or hepatitis B
- positive for hepatitis C virus, with moderate or severe liver disease;
- active malignancy or history of malignancy, excluding skin cancer (basal or squamous
cell) that has been adequately treated;
- need for maintenance corticosteroids for another condition.
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients achieving therapeutic window by Day 5\n
Canada: Health Canada