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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01541670
Recruitment Status : Terminated
First Posted : March 1, 2012
Last Update Posted : October 23, 2017
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Brief Summary:
The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Assess the Safety and Tolerability of Anti-MIF Antibody in Subjects With Lupus Nephritis
Study Start Date : November 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 now part of Shire
Study Director: BioScience Investigator Baxter Healthcare Corporation

Responsible Party: Baxalta now part of Shire Identifier: NCT01541670     History of Changes
Other Study ID Numbers: 391001
First Posted: March 1, 2012    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: May 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