Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University Health Network, Toronto Genzyme St. Michael's Hospital, Toronto St. Paul's Hospital, Canada |
---|---|
Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00706680 |
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.
Condition | Intervention | Phase |
---|---|---|
Diabetes Graft Rejection |
Drug: Thymoglobulin |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Use of Thymoglobulin in a Calcineurin Inhibitor and Steroid Minimization Protocol |
Estimated Enrollment: | 30 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
All subjects meeting the entry criteria will be treated with the study immunosuppressive protocol.
|
Drug: 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.
|
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Edward Cole | 416-340-4800 ext 4669 | edward.cole@uhn.on.ca |
Contact: Bricio Rodriguez | 416-340-4800 ext 5921 | bricio.rodriguez@uhn.on.ca |
Canada, British Columbia | |
St Paul's Hospital | Not yet recruiting |
Vancouver, British Columbia, Canada, V6Z 2E8 | |
Contact: John Gill 604-681-7191 | |
Principal Investigator: John Gill | |
Sub-Investigator: David Landsberg | |
Canada, Ontario | |
University health Network | Recruiting |
Toronto, Ontario, Canada, M5G 2N2 | |
Contact: Bricio Rodriguez 416-340-4800 ext 5921 bricio.rodriguez@uhn.on.ca | |
Sub-Investigator: Carl Cardella | |
Principal Investigator: Edward Cole | |
St Michael's Hospital | Not yet recruiting |
Toronto, Ontario, Canada, M5C 2T2 | |
Contact: Ramesh Prasad (416) 867-3722 Ramesh.Prasad@utoronto.ca | |
Principal Investigator: Ramesh Prasad | |
Sub-Investigator: Jeffrey Zaltzman |
Study Director: | Edward Cole | University Health Network, Toronto |
Principal Investigator: | John Gill | St Paul's Hospital |
Principal Investigator: | Ramesh Prasad | St. Michael's Hospital, Toronto |
Responsible Party: | University Health Network ( Dr. Edward Cole ) |
Study ID Numbers: | 07-0619-A |
Study First Received: | February 8, 2008 |
Last Updated: | June 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00706680 |
Health Authority: | Canada: Health Canada |
Prednisone Cyclosporine Methylprednisolone Prednisolone Mycophenolate mofetil Mycophenolic Acid |
Diabetes Mellitus Methylprednisolone acetate Prednisolone acetate Cyclosporins Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Enzyme Inhibitors Immunosuppressive Agents Glucocorticoids Hormones Pharmacologic Actions Therapeutic Uses |