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| Name | Class |
|---|---|
| Emergent Product Development Seattle LLC | INDUSTRY |
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The purpose of this study is to determine how the body absorbs and chemically changes a single infusion of TRU-015 in subjects with kidney disease caused by lupus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRU-015 | Drug | Arm 1 = 800 mg Arm 2 = 2000 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics of TRU-015 after a single administration in subjects with membranous nephropathy secondary to systemic lupus erythematosus. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety, immunogenicity, and pharmacokinetic/pharmacodynamic relationship of TRU-015 in subjects with membranous nephropathy secondary to systemic lupus erythematosus. | 1 year |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90048 | United States | |||
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| Palo Alto |
| California |
| 94304 |
| United States |
| Lake Success | New York | 11042 | United States |
| Rochester | New York | 14642 | United States |
| Charlotte | North Carolina | 28208 | United States |
| Columbus | Ohio | 43210 | United States |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D015433 | Glomerulonephritis, Membranous |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C540931 | TRU-015 protein |
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