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The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label Dose-Escalation Arm | Experimental | Conducted in an ascending dose manner, subjects will be assigned to single- or multiple-dose administration of the investigational product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody | Drug | Intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality | Week 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetic parameters | Maximum concentration (Cmax), minimum concentration (Cmin), area under the curve (AUC), half-life (t1/2), clearance (CL) , mean residence time (MRT), volume of distribution at steady state (Vdss) | Week 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Research Institute Inc. | Los Angeles | California | 90022 | United States | ||
| Mohamed A. El-Shahawy |
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| Los Angeles |
| California |
| 90022 |
| United States |
| North Valley Nephrology | Yuba City | California | 95991 | United States |
| IMMUNOe International Research Centers | Centennial | Colorado | 80112 | United States |
| University of Colorado | Denver | Colorado | 80220 | United States |
| Tulane University Hospital & Clinic | New Orleans | Louisiana | 70112 | United States |
| Clinical Research Development Associates, LLC | Springfield Gardens | New York | 11413 | United States |
| Northeast Clinical Research Center, LLC | Bethlehem | Pennsylvania | 18017 | United States |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | United States |
| Ramesh Gupta | Memphis | Tennessee | 38016 | United States |
| Ramesh Gupta | Memphis | Tennessee | 38119 | United States |
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 75390-8523 | United States |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3052 | Australia |
| Linear Clinical Research Limited | Nedlands | Western Australia | 6009 | Australia |
| CHUM Hôpital Saint-Luc | Montreal | Quebec | H2X 3J4 | Canada |
| St. Paul´s Hospital | Saskatoon | Saskatchewan | S7M 0Z9 | Canada |
| Mexico Center for Clinical Research S.A de C.V | Mexico City | Mexico City | 3100 | Mexico |
| Hospital y Clinica OCA SA de CV | Monterrey | Nuevo León | 64000 | Mexico |
| Hospital Universitario Dr Jose Eleuterio Gonzalez | Monterrey | Nuevo León | 64460 | Mexico |
| Clinica San Jose | Sonora | Obregon | 85000 | Mexico |
| Hospital CIMA Chihuahua | Chihuahua City | 31238 | Mexico |
| Auckland City Hospital | Auckland | 1071 | New Zealand |
| Middlemore Hospital | Auckland | 1640 | New Zealand |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000906 | Antibodies |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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