A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection
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|ClinicalTrials.gov Identifier: NCT00089947|
Recruitment Status : Completed
First Posted : August 20, 2004
Last Update Posted : March 18, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplantation Graft Rejection||Drug: Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2005|
- This study will evaluate the effect of Thymoglobulin and reduced doses of steroids to prevent renal transplant rejection, organ loss and death at 6 months.
- To evaluate patient kidney function after transplantation and the overall safety of Thymoglobulin in this patient population.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089947
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|