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