drugset / Trial / NCT00214266
A Pilot Study of Campath-1H Induction Therapy Combined With CellCept® Therapy to Allow for a Calcineurin Inhibitor Free Regimen After Renal Transplantation
NaSingle-groupOpen-labelTreatment
Summary
The hypothesis of this study is that lymphocyte depletion by Campath-1H and rituximab will obviate the need for long-term calcineurin inhibitors in renal transplantation. Most successful strategies to date have relied on the use of either tacrolimus or cyclosporine. However, the advantage of a calcineurin inhibitor free regimen may include improved renal allograft function, a lower incidence of hypertension, diabetes, and less drug related side effects. This is a non-randomized open-label pilot trial in 30 adult renal transplant patients.
Timeline
- Start
- 2005-01
- Primary completion
- 2007-08
- Completion
- 2007-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alemtuzumab | Monoclonal antibody | 30 mg | Intravenous |
| Subject | Mycophenolate Mofetil | Small molecule | 1000 mg | — |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
Indications
No indication recorded.