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The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients.
The purpose of this study is to evaluate the safety and efficacy of TCD601 (siplizumab), an anti-CD2 monoclonal antibody, in combination with a CNI-free regimen of belatacept, MPA, and corticosteroids compared to a standard of care CNI-based regimen of tacrolimus, ATG, MPA and corticosteroids in de novo renal transplant patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCD601 (siplizumab) | Experimental | TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids |
|
| ATG | Active Comparator | Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCD601 | Biological | Investigational Product |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2 | The number of adverse events and serious adverse events | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function in Arm 1 compared to Arm 2 | renal function using estimated glomerular filtration rate (eGFR) | 12 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fredrik Juhlin | ITB-Med LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Medical Center | Sacramento | California | 95817 | United States | ||
| University of California San Francisco Medical Center |
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| belatacept | Biological | Study Product |
|
| ATG | Drug | Comparator |
|
|
| TAC | Drug | Comparator |
|
|
| MPA | Drug | Immunosuppression Therapy |
|
|
| Corticosteroids | Drug | Immunosuppression Therapy |
|
| San Francisco |
| California |
| 94143 |
| United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Atrium Health Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Virginia Health | Charlottesville | Virginia | 22903 | United States |
| Inova Fairfax Hospital Medical Campus | Falls Church | Virginia | 22042 | United States |
| ID | Term |
|---|---|
| C544394 | siplizumab |
| D000069594 | Abatacept |
| D000961 | Antilymphocyte Serum |
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D007106 | Immune Sera |
| D007162 | Immunoproteins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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