Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol

• Status: Unknown status
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborators: Genzyme, a Sanofi Company; St. Michael's Hospital, Toronto; St. Paul's Hospital, Canada; Unity Health Toronto
• Treatments: Calcineurin Inhibitors; Cyclosporine; Cyclosporins; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Thymoglobulin

Criteria

Inclusion Criteria:

• De Novo, single Kidney recipient

• At least 1 HLA mismatch

Exclusion Criteria:

• Recipient of multiple organs

• prior transplant recipient

• Subjects who have Diabetes prior to transplant, as indicated by pre-transplant OGTT

• PRA >10%

• Hepatitis B surface antigen positive

• Hepatitis C antibody positive

• HIV positive