Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089947
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2004-08-18
Brief Title:
A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Randomized Prospective Phase 2 Study Comparing Thymoglobulin in a Rapid Discontinuation of Corticosteroids Protocol With Standard Corticosteroid Therapy in Living Donor Renal Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study involves the use of a drug called Thymoglobulin which is approved in the US to treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant rejection
This study will evaluate the effect of Thymoglobulin and reduced doses of steroids to prevent renal transplant rejection and will provide a basis for future evaluations of Thymoglobulin as an immunosuppressive agent to help prevent renal transplant rejection
Subjects meeting all inclusion and exclusion criteria are eligible to participate in this study In addition to standard treatment study participants will receive either Thymoglobulin with rapid discontinuation of steroids or steroids per hospital standards for at least the first 90 days after transplant The treatment assignment is random and is not chosen by the subject or their physician
Subjects will be monitored during treatment with Thymoglobulin and during the transplant hospitalization Additional subject monitoring occurs at Months 1 3 6 and 12 following the transplant
Approximately 150 study subjects from 15-20 transplant centers in the United States will be enrolled
This study will evaluate the effect of Thymoglobulin and reduced doses of steroids to prevent renal transplant rejection and will provide a basis for future evaluations of Thymoglobulin as an immunosuppressive agent to help prevent renal transplant rejection
Subjects meeting all inclusion and exclusion criteria are eligible to participate in this study In addition to standard treatment study participants will receive either Thymoglobulin with rapid discontinuation of steroids or steroids per hospital standards for at least the first 90 days after transplant The treatment assignment is random and is not chosen by the subject or their physician
Subjects will be monitored during treatment with Thymoglobulin and during the transplant hospitalization Additional subject monitoring occurs at Months 1 3 6 and 12 following the transplant
Approximately 150 study subjects from 15-20 transplant centers in the United States will be enrolled
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None