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Safety Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Lupus Nephritis

This study has been terminated.
Information provided by (Responsible Party):
Baxalta US Inc. Identifier:
First received: February 20, 2012
Last updated: June 26, 2015
Last verified: May 2015
The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis.

Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Assess the Safety and Tolerability of Anti-MIF Antibody in Subjects With Lupus Nephritis

Resource links provided by NLM:

Further study details as provided by Baxalta US Inc.:

Primary Outcome Measures:
  • Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality [ Time Frame: Week 21 ]

Secondary Outcome Measures:
  • Plasma pharmacokinetic parameters [ Time Frame: Week 21 ]
    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)

Enrollment: 4
Study Start Date: November 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody
Intravenous injection


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed and dated written informed consent obtained from the subject
  • 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:

  • Any significant health problem other than lupus or lupus nephritis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01541670

  Hide Study Locations
United States, California
Academic Medical Research Institute Inc.
Los Angeles, California, United States, 90022
Mohamed A. El-Shahawy
Los Angeles, California, United States, 90022
North Valley Nephrology
Yuba City, California, United States, 95991
United States, Colorado
IMMUNOe International Research Centers
Centennial, Colorado, United States, 80112
University of Colorado
Denver, Colorado, United States, 80220
United States, Louisiana
Tulane University Hospital & Clinic
New Orleans, Louisiana, United States, 70112
United States, New York
Clinical Research Development Associates, LLC
Springfield Gardens, New York, United States, 11413
United States, Pennsylvania
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, United States, 18017
United States, South Carolina
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
United States, Tennessee
Ramesh Gupta
Memphis, Tennessee, United States, 38016
Ramesh Gupta
Memphis, Tennessee, United States, 38119
United States, Texas
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8523
Australia, Victoria
Austin Health
Heidelberg, Victoria, Australia, 3084
The Alfred Hospital
Melbourne, Victoria, Australia, 3052
Australia, Western Australia
Linear Clinical Research Limited
Nedlands, Western Australia, Australia, 6009
Canada, Quebec
CHUM Hôpital Saint-Luc
Montréal, Quebec, Canada, H2X 3J4
Canada, Saskatchewan
St. Paul´s Hospital
Saskatoon, Saskatchewan, Canada, S7M 0Z9
Mexico Center for Clinical Research S.A de C.V
Mexico City, Distrito Federal, Mexico, 3100
Hospital y Clinica OCA SA de CV
Monterrey, Nuevo León, Mexico, 64000
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico, 64460
Clinica San Jose
Obrergon, Sonora, Mexico, 85000
Hospital CIMA Chihuahua
Chihuahua, Mexico, 31238
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1071
Middlemore Hospital
Auckland, New Zealand, 1640
Sponsors and Collaborators
Baxalta US Inc.
Study Director: BioScience Investigator Baxter Healthcare Corporation
  More Information

Responsible Party: Baxalta US Inc. Identifier: NCT01541670     History of Changes
Other Study ID Numbers: 391001
Study First Received: February 20, 2012
Last Updated: June 26, 2015

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Nephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on April 21, 2017