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

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Renal Transplantation

Treatments: Drug: Campath 1H®, Rituximab, mycophenolate mofetil

Study type: Interventional

Funder types: Other

Identifiers

NCT00214266

H-2004-0209

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Campath-1H Induction Therapy Combined With CellCept® Therapy

Experimental group

Description:

Campath-1H Induction Therapy Combined With CellCept® Therapy

Treatment:

Drug: Campath 1H®, Rituximab, mycophenolate mofetil