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