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

Completed · Phase 2

Conditions studied: Renal Transplantation

In brief

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 facts

Study ID

NCT00214266

Run by

University of Wisconsin, Madison

People needed

31

Starts

2005-01-01

Expected to finish

2007-09-01

Last updated by the study team

2018-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• renal transplant recipients

You may not qualify if…

• Recipients of HLA-identical living-donor renal transplants;
• multi-organ transplant;
• known hypersensitivity to Campath-1H, Rituximab, CellCept, or prednisone;

Where it is running

• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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