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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
| Unity Health Toronto | OTHER |
| St. Paul's Hospital, Canada | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | All subjects meeting the entry criteria will be treated with the study immunosuppressive protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymoglobulin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients developing New Onset Diabetes post transplant, as identified by an oral glucose tolerance test | 6 months post transplant. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute rejection | 6 months post transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edward Cole | Contact | 416-340-4800 | 4669 | edward.cole@uhn.on.ca |
| Bricio Rodriguez | Contact | 416-340-4800 | 5921 | bricio.rodriguez@uhn.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Edward Cole | University Health Network, Toronto | Study Director |
| John Gill | St. Paul's Hospital | Principal Investigator |
| Ramesh Prasad |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Paul's Hospital | Not yet recruiting | Vancouver | British Columbia | V6Z 2E8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23369458 | Derived | 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. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C512542 | thymoglobulin |
| D008776 | Methylprednisolone Hemisuccinate |
| D013256 | Steroids |
| D011241 | Prednisone |
| D009173 | Mycophenolic Acid |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
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|
|
| Unity Health Toronto |
| Principal Investigator |
| St Michael's Hospital | Not yet recruiting | Toronto | Ontario | M5C 2T2 | Canada |
|
| University health Network | Recruiting | Toronto | Ontario | M5G 2N2 | Canada |
|
| D011278 |
| Pregnanes |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |