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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01541670
First Posted: March 1, 2012
Last Update Posted: October 23, 2017
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.
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )
  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: 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

Resource links provided by NLM:


Further study details as provided by Shire ( Baxalta now part of Shire ):

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT01541670


  Show 24 Study Locations
Sponsors and Collaborators
Baxalta now part of Shire
Investigators
Study Director: BioScience Investigator Baxter Healthcare Corporation
  More Information

Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT01541670     History of Changes
Other Study ID Numbers: 391001
First Submitted: February 20, 2012
First Posted: March 1, 2012
Last Update Posted: October 23, 2017
Last Verified: May 2015

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