A Phase 2 interventional study of Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] in Renal Transplantation and Graft Rejection, sponsored by Genzyme, a Sanofi Company. Completed at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-18.
Sponsored by Genzyme, a Sanofi Company · Phase 2, Interventional, and Treatment
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.
Genzyme, a Sanofi Company is the lead sponsor of 303 studies on the registry; 5 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Genzyme, a Sanofi Company