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

NCT00214266

Phase 2 Completed 31 enrolled University of Wisconsin, Madison
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

EvaluationDrugModalityDoseRoute
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.