A Pilot Study of Campath-1H Induction Therapy Combined With CellCept® Therapy to Allow for a Calcineurin Inhibitor Free Regimen After Renal Transplantation
Phase 2
Completed
- Conditions
- Renal Transplantation
- Interventions
- Registration Number
- NCT00214266
- Lead Sponsor
- University of Wisconsin, Madison
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Campath-1H Induction Therapy Combined With CellCept® Therapy Campath 1H®, Rituximab, mycophenolate mofetil Campath-1H Induction Therapy Combined With CellCept® Therapy
- Primary Outcome Measures
Name Time Method renal allograft function 2 years
- Secondary Outcome Measures
Name Time Method incidence of diabetes 2 years incidence of hypertension 2 years drug related side effects 2 years
Trial Locations
- Locations (1)
University of Wisconsin
🇺🇸Madison, Wisconsin, United States