A Pilot Study of Campath-1H Induction Therapy Combined With CellCept® Therapy to Allow for a Calcineurin Inhibitor Free Regimen After Renal Transplantation
Part of paid clinical trials in Madison, Wisconsin.
- Sponsor
- University of Wisconsin, Madison
- Study ID
- NCT00214266
- Phase
- PHASE2
- Status
- Completed
Conditions
- Renal Transplantation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Campath 1H®, Rituximab, mycophenolate mofetil — DRUGInduction therapy with Campath 30mg IV x 2 doses, Rituximab 375mg/m2 x 1, corticosteroids, and mycophenolate 1000mg bid
Study Details
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.
Key Dates
- Start date
- Jan 31, 2005
- Status verified
- May 2018
- Primary completion
- Aug 31, 2007
- Completion
- Sep 30, 2007
Study Design
- Enrollment
- 31 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Campath-1H Induction Therapy Combined With CellCept® TherapyCampath-1H Induction Therapy Combined With CellCept® Therapy
Primary Outcome Measure
renal allograft function [ Time Frame: 2 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | - |
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