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Sponsor decision, indication no longer under evaluation
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The purpose of this study is to determine the optimal regimen for the use of siplizumab, a human anti-CD2 antibody, combined with donor bone marrow cells and non-myeloablative conditioning, for tolerance induction in living donor renal transplantation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | TCD601administered with non-myeloablative conditioning and standard of care immunosuppression |
|
| Arm 2 | Experimental | TCD601administered with non-myeloablative conditioning and standard of care immunosuppression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCD601 | Biological | Investigational Product |
|
| Measure | Description | Time Frame |
|---|---|---|
| The optimal regimen for renal allograft tolerance while minimizing chimeric transition syndrome | The proportion of patients off immunosuppression with good safety and tolerability | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of biopsy proven acute rejection, death and graft loss | 24 months | |
| The incidence of de novo donor-specific antibody | 24 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracy Killingsworth | Nefro Avillion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
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