drugset / Trial / NCT00729768
A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase II/III, randomized, open-label, active-controlled, multicenter trial to evaluate the safety and efficacy of efalizumab compared with cyclosporine (CsA), when both are given in combination with Mycophenolate Mofetil (MMF) and corticosteroids after induction therapy with basiliximab, as an immunosuppressant regimen in de novo renal transplantation. A total of 200 subjects undergoing either living or cadaveric renal transplantation will be randomly assigned 1:1 to receive either efalizumab + MMF + corticosteroids or CsA + MMF + corticosteroids.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclosporine | Peptide | — | Oral |
| Subject | efalizumab | Monoclonal antibody | — | Subcutaneous |
| Background | Basiliximab | Monoclonal antibody | — | Intravenous |
| Background | Corticosteroids | Unknown | — | — |
| Background | Mycophenolate Mofetil | Small molecule | — | Oral |
Indications
No indication recorded.