OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
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.