Status:
UNKNOWN
Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Genzyme, a Sanofi Company
Unity Health Toronto
Conditions:
Diabetes
Graft Rejection
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 diab...
Detailed 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, wi...
Eligibility Criteria
Inclusion
- De Novo, single Kidney recipient
- At least 1 HLA mismatch
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00706680
Start Date
February 1 2008
End Date
June 1 2009
Last Update
June 27 2008
Active Locations (3)
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1
St Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 2E8
2
St Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2
3
University health Network
Toronto, Ontario, Canada, M5G 2N2