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Simultaneous Islet-Kidney Transplantation in Patients of Type 1 Diabetes With End-stage Renal Disease

Type 1 Diabetes Mellitus Clinical Trial

Official title:
Simultaneous Islet-Kidney Transplantation in Patients of Type 1 Diabetes With End-stage Renal Disease

Clinical Trial Summary

The aim of this study was to evaluate the efficiency and safety of simultaneous islet-kidney transplantation in patients of type 1 diabetes with end-stage renal disease using a glucocorticoid-free immunosuppressive regimen with alemtuzumab induction. Islet transplantation can result in insulin independence with excellent metabolic control when glucocorticoid-free immunosuppression is combined with the infusion of an adequate islet mass. Alemtuzumab (Campath-1H ®) is a 150-kDa humanized IgG1 monoclonal antibody that targets the CD52 antigen. Prolonged lymphocyte depletion can be expected following alemtuzumab treatment.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00692562
Study type Interventional
Source Fuzhou General Hospital
Contact
Status Completed
Phase Phase 1/Phase 2
Start date June 2005
Completion date December 2007
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