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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01541670
First received: February 20, 2012
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

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: Endpoint Classification: Pharmacokinetics/Dynamics Study
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 Baxter Healthcare Corporation:

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

Secondary Outcome Measures:
  • Plasma pharmacokinetic parameters [ Time Frame: Week 21 ] [ Designated as safety issue: No ]
    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
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: September 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01541670

  Hide Study Locations
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, 38119
Ramesh Gupta
Memphis, Tennessee, United States, 38016
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
Mexico Center for Clinical Research S.A de C.V
Mexico City, Distrito Federal, Mexico, 3100
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico, 64460
Hospital y Clinica OCA SA de CV
Monterrey, Nuevo León, Mexico, 64000
Clinica San Jose
Obrergon, Sonora, Mexico, 85000
Hospital CIMA Chihuahua
Chihuahua, Mexico, 31238
New Zealand
Middlemore Hospital
Auckland, New Zealand, 1640
Auckland City Hospital
Auckland, New Zealand, 1071
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: BioScience Investigator Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01541670     History of Changes
Other Study ID Numbers: 391001
Study First Received: February 20, 2012
Last Updated: March 20, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Mexico: Secretaria de Salud
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Nephritis
Nephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014