CLEAR Study - A Study of CellCept (Mycophenolate Mofetil) in Recipients of Kidney Transplants

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

This study will compare the efficacy and safety of 2 dosing regimens of oral CellCept administered as a component of standard immunosuppressive therapy in recipients of kidney transplants. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Inclusion Criteria:

• adult patients >=18 years of age;
• recipients of a primary kidney transplant.

Exclusion Criteria:

• positive for HIV-1, human T-cell leukemia/lymphoma virus-1 (HTLV-1), or hepatitis B surface antigen;
• 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.