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

  Show 24 Study Locations
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
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014