drugset / Trial / NCT02005562
OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2006-05
- Primary completion
- 2009-03
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mycophenolate Mofetil | Small molecule | 2 g | Oral |
| Comparator | Mycophenolate Mofetil | Small molecule | 3 g | Oral |
| Background | Cyclosporine | Peptide | — | — |
| Background | Methylprednisolone | Other / unclassified | 0.5 mg/kg | Intravenous |
| Background | anti-IL-2R | Unknown | — | — |
Indications
No indication recorded.