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Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol

Information source: University Health Network, Toronto
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes; Graft Rejection

Intervention: Thymoglobulin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Health Network, Toronto

Official(s) and/or principal investigator(s):
Edward Cole, Study Director, Affiliation: University Health Network, Toronto
John Gill, Principal Investigator, Affiliation: St. Paul's Hospital
Ramesh Prasad, Principal Investigator, Affiliation: St. Michael's Hospital, Toronto

Overall contact:
Edward Cole, Phone: 416-340-4800, Ext: 4669, Email: edward.cole@uhn.on.ca


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 Details

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

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

Primary outcome: Percentage of patients developing New Onset Diabetes post transplant, as identified by an oral glucose tolerance test

Secondary outcome: Incidence of acute rejection

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, 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.


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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

Locations and Contacts

Edward Cole, Phone: 416-340-4800, Ext: 4669, Email: edward.cole@uhn.on.ca

St Paul's Hospital, Vancouver, British Columbia V6Z 2E8, Canada; Not yet recruiting
John Gill, Phone: 604-681-7191
John Gill, Principal Investigator
David Landsberg, Sub-Investigator

St Michael's Hospital, Toronto, Ontario M5C 2T2, Canada; Not yet recruiting
Ramesh Prasad, Phone: (416) 867-3722, Email: Ramesh.Prasad@utoronto.ca
Ramesh Prasad, Principal Investigator
Jeffrey Zaltzman, Sub-Investigator

University health Network, Toronto, Ontario M5G 2N2, Canada; Recruiting
Bricio Rodriguez, Phone: 416-340-4800, Ext: 5921, Email: bricio.rodriguez@uhn.on.ca
Carl Cardella, Sub-Investigator
Edward Cole, Principal Investigator

Additional Information

Starting date: February 2008
Last updated: June 25, 2008

Page last updated: August 23, 2015

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