OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.

A Randomized Study Comparing the Incidence of Acute Clinical or Subclinical Rejection With Two Dosing Regimens of CellCept in de Novo Renal Transplant Recipients Receiving Induction, Cyclosporine and Brief Steroid Therapy

This study will compare the incidence of acute clinical or subclinical rejection between immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug monitoring and standard immunosuppression with CellCept and a fixed dose of 2g po daily, in kidney transplant recipients receiving induction by anti-IRL2, cyclosporine therapy, and early discontinuation of steroids. Patients will be randomized to one of the two treatment arms. The anticipated time on study treatment is 52 weeks.

Inclusion Criteria:

• adult patients, aged 18-75 years of age;
• in receipt of first donor kidney;
• eligible to receive immunosuppressive treatment comprising IRL2, CellCept, cyclosporine and steroids;
• eligible to receive oral treatment from the first day post-transplantation.

Exclusion Criteria:

• patients receiving a second or subsequent kidney transplant, or multi-organ transplant;
• history of malignancy in the last 5 years (except successfully treated squamous cell or basal cell cancer and cervical cancer in situ);
• patients with active hepatitis B and/or hepatitis C, or HIV infection.