drugset / Trial / NCT00177138

Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation

NCT00177138

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a single center, prospective, open-label, randomized trial at the University of Minnesota Medical Center,Fairview. Primary objectives are to determine if rejection episodes and loss rates, graft survival, level of renal graft function, and patient survival rates with a Campath/MMF-based (Group 1) immunosuppressive protocol are lower than, or equal to, our protocol using thymoglobulin, tacrolimus, and MMF (Group 2). This study will investigate the first protocol that is both steroid-free and calcineurin inhibitor-free in pancreas after kidney transplant recipients.

Timeline

Start
2004-07
Primary completion
Completion
2006-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Alemtuzumab Monoclonal antibody 30 mg Intravenous
Comparator Tacrolimus Small molecule 0.06 mg/kg

Indications