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
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: Alemtuzumab; Calcineurin Inhibitors; Mycophenolate mofetil; Mycophenolic Acid; Rituximab

Criteria

Inclusion Criteria:

• renal transplant recipients

Exclusion Criteria:

• Recipients of HLA-identical living-donor renal transplants;

• multi-organ transplant;

• known hypersensitivity to Campath-1H, Rituximab, CellCept, or prednisone;