Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University Health Network, Toronto.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Health Network, Toronto
Collaborators:
Genzyme, a Sanofi Company
St. Michael's Hospital, Toronto
St. Paul's Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00706680
First received: February 8, 2008
Last updated: June 25, 2008
Last verified: February 2008
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Purpose
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 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | The Use of Thymoglobulin in a Calcineurin Inhibitor and Steroid Minimization Protocol |
Resource links provided by NLM:
MedlinePlus related topics:
Steroids
Drug Information available for:
Prednisone
Mycophenolic acid
Mycophenolate sodium
Cyclosporine
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
U.S. FDA Resources
Further study details as provided by University Health Network, Toronto:
Primary Outcome Measures:
- Percentage of patients developing New Onset Diabetes post transplant, as identified by an oral glucose tolerance test [ Time Frame: 6 months post transplant. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence of acute rejection [ Time Frame: 6 months post transplant ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
|
Experimental: 1
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.
Other Names:
|
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706680
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706680
Contacts
| 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 |
Locations
| 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 | |
| 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 | |
| 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 | |
Sponsors and Collaborators
University Health Network, Toronto
Genzyme, a Sanofi Company
St. Michael's Hospital, Toronto
St. Paul's Hospital, Canada
Investigators
| 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 |
More Information
| Responsible Party: | Dr. Edward Cole, University Health Network |
| ClinicalTrials.gov Identifier: | NCT00706680 History of Changes |
| Other Study ID Numbers: | 07-0619-A |
| Study First Received: | February 8, 2008 |
| Last Updated: | June 25, 2008 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Prednisone Mycophenolic Acid Cyclosporins Cyclosporine Mycophenolate mofetil Calcineurin Inhibitors Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Antineoplastic Agents, Hormonal Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents Antibiotics, Antineoplastic |
ClinicalTrials.gov processed this record on September 28, 2016