Safety Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Lupus Nephritis
NCT ID: NCT01541670
Last Updated: 2021-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
4 participants
INTERVENTIONAL
2011-11-28
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open-label Dose-Escalation Arm
Conducted in an ascending dose manner, subjects will be assigned to single- or multiple-dose administration of the investigational product
Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody
Intravenous injection
Interventions
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Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody
Intravenous injection
Eligibility Criteria
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Inclusion Criteria
* Males and females of age 18 years and older at the time of screening
* Established diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology classification criteria
* Documented renal biopsy evidence of proliferative glomerulonephritis prior to screening
* Urine protein-to-creatinine ratio \> 0.5 (mg/mg)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Baxalta now part of Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Academic Medical Research Institute Inc.
Los Angeles, California, United States
Mohamed A. El-Shahawy
Los Angeles, California, United States
North Valley Nephrology
Yuba City, California, United States
IMMUNOe International Research Centers
Centennial, Colorado, United States
University of Colorado
Denver, Colorado, United States
Tulane University Hospital & Clinic
New Orleans, Louisiana, United States
Clinical Research Development Associates, LLC
Springfield Gardens, New York, United States
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Ramesh Gupta
Memphis, Tennessee, United States
Ramesh Gupta
Memphis, Tennessee, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
Austin Health
Heidelberg, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Linear Clinical Research Limited
Nedlands, Western Australia, Australia
CHUM Hôpital Saint-Luc
Montreal, Quebec, Canada
St. Paul´s Hospital
Saskatoon, Saskatchewan, Canada
Mexico Center for Clinical Research S.A de C.V
Mexico City, Mexico City, Mexico
Hospital y Clinica OCA SA de CV
Monterrey, Nuevo León, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico
Clinica San Jose
Sonora, Obregon, Mexico
Hospital CIMA Chihuahua
Chihuahua City, , Mexico
Auckland City Hospital
Auckland, , New Zealand
Middlemore Hospital
Auckland, , New Zealand
Countries
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Other Identifiers
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391001
Identifier Type: -
Identifier Source: org_study_id
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