Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol

Diabetes Clinical Trial

Official title: The Use of Thymoglobulin in a Calcineurin Inhibitor and Steroid Minimization Protocol

Status Recruiting

Clinical Trial Summary

This study has been designed to test whether using Thymoglobulin with low dose Cyclosporine and early steroid dosage reduction will minimize both kidney rejection and the development of new onset diabetes mellitus after renal transplant.

Clinical Trial Description

All patients will receive methyl prednisone intravenously pre-operatively, as per institutional practice. Thymoglobulin will be initiated prior to completion of the anastomosis, or if not possible, within 24 hours of transplantation in all patients and a total dose of 6-7.5mg/kg will be given over 3-5 doses. Steroids will be initiated post-operatively at 1mg/kg/day for 2 days, then 0.5mg/kg/day for 2 days, then 0.25mg/kg/day for 2 days and then patients will be placed on 5mg daily for the remainder of the study. All patients will receive Mycophenolic acid at a dose of 2gm/day (Cellcept) or 1440mg/day (Myfortic) post-transplantation with dose adjustment as needed. Cyclosporine micro-emulsion will be initiated when renal function is established or no later than day 10 in a dose of 3mg/kg twice daily with adjustment to achieve a C2 target of 600-800 nanograms/ml. ;

Study Design

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

Related Conditions & MeSH terms

• Diabetes
• Graft Rejection

• NCT number: NCT00706680
• Study type: Interventional
• Source: University Health Network, Toronto
• Contact: Edward Cole
• Phone: 416-340-4800
• Email: edward.cole@uhn.on.ca
• Status: Recruiting
• Phase: Phase 4
• Start date: February 2008
• Completion date: June 2009