Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol
NCT ID: NCT00706680
Last Updated: 2008-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2008-02-29
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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1
All subjects meeting the entry criteria will be treated with the study immunosuppressive protocol.
Thymoglobulin
methyl prednisone intravenously pre-operatively, as per institutional practice. Thymoglobulin, initiated prior to completion of the anastomosis, or if not possible, within 24 hours of transplantation for a total dose of 6-7.5mg/kg given over 3-5 doses. Steroids 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. 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.
Interventions
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Thymoglobulin
methyl prednisone intravenously pre-operatively, as per institutional practice. Thymoglobulin, initiated prior to completion of the anastomosis, or if not possible, within 24 hours of transplantation for a total dose of 6-7.5mg/kg given over 3-5 doses. Steroids 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. 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 1 HLA mismatch
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Unity Health Toronto
OTHER
St. Paul's Hospital, Canada
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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University Health Network
Principal Investigators
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Edward Cole
Role: STUDY_DIRECTOR
University Health Network, Toronto
John Gill
Role: PRINCIPAL_INVESTIGATOR
St. Paul's Hospital
Ramesh Prasad
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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St Paul's Hospital
Vancouver, British Columbia, Canada
St Michael's Hospital
Toronto, Ontario, Canada
University health Network
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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John Gill
Role: primary
Ramesh Prasad
Role: primary
Bricio Rodriguez
Role: primary
References
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Cole EH, Prasad GV, Cardella CJ, Kim JS, Tinckam KJ, Cattran DC, Schiff JR, Landsberg DN, Zaltzman JS, Gill JS. A pilot study of reduced dose cyclosporine and corticosteroids to reduce new onset diabetes mellitus and acute rejection in kidney transplant recipients. Transplant Res. 2013 Jan 12;2(1):1. doi: 10.1186/2047-1440-2-1.
Other Identifiers
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07-0619-A
Identifier Type: -
Identifier Source: org_study_id