NCT00214266

A Pilot Study of Campath-1H Induction Therapy Combined With CellCept® Therapy to Allow for a Calcineurin Inhibitor Free Regimen After Renal Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	Campath 1H®, Rituximab, mycophenolate mofetil	Induction therapy with Campath 30mg IV x 2 doses, Rituximab 375mg/m2 x 1, corticosteroids, and mycophenolate 1000mg bid

Timeline

• Start date: 2005-01-01
• Primary completion: 2007-08-01
• Completion: 2007-09-01
• First posted: 2005-09-21
• Last updated: 2018-05-30

Locations

1 site across 1 country: United States