Campath, Rituximab, and Myfortic With Short-Course Calcineurin Inhibitor Therapy in Renal Transplanation
Status:
Terminated
Trial end date:
2007-04-01
Target enrollment:
Participant gender:
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 for
an indefinite period of time. However, the advantage of a long term, 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. Subjects will receive 2 doses
of Campath-1H (30mg given on Day 0 and Day 1) and a single dose of Rituximab (375mg/m2) on
Day 0, given intra-operative. Subjects will take maintenance doses of prednisone and enteric
coated mycophenolate sodium (Myfortic™). Subject will also be given cyclosporine (Neoral®)
therapy for approximately 2 weeks (10-20 days).