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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):
Baxalta US Inc.
ClinicalTrials.gov Identifier:
NCT01541670
First received: February 20, 2012
Last updated: June 26, 2015
Last verified: May 2015

February 20, 2012
June 26, 2015
November 2011
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01541670 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
Safety Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Lupus Nephritis
A Study to Assess the Safety and Tolerability of Anti-MIF Antibody in Subjects With Lupus Nephritis
The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis.
Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Systemic Lupus Erythematosus
Drug: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody
Intravenous injection
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
Intervention: Drug: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Mexico,   New Zealand
 
NCT01541670
391001
Yes
Not Provided
Not Provided
Baxalta US Inc.
Baxalta US Inc.
Not Provided
Study Director: BioScience Investigator Baxter Healthcare Corporation
Baxalta US Inc.
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP