Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate patient kidney function after transplantation and the overall safety of Thymoglobulin in this patient population. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Science | Little Rock | Arkansas | 72205 | United States | ||
| Keck USC School of Medicine |
Not provided
| Label | URL |
|---|---|
| US FDA Approved Full Prescribing Information for Thymoglobulin® | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Los Angeles |
| California |
| 90033 |
| United States |
| University of California, Los Angeles Medical Center | Los Angeles | California | 90095 | United States |
| University of California, San Diego Medical Center | San Diego | California | 92103 | United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| University of Colorado Health Sciences Center | Denver | Colorado | 80262 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Oschner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Johns Hopkins University Hospital | Baltimore | Maryland | 21287 | United States |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| Texas Transplant Institute | San Antonio | Texas | 78229 | United States |
| Medical College of Virginia | Richmond | Virginia | 23298 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| C512542 | thymoglobulin |
| D000961 | Antilymphocyte Serum |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided