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

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Study to Assess the Safety and Tolerability of Anti-MIF Antibody in Subjects With Lupus Nephritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01541670
• Other study ID #: 391001
• Status: Terminated
• Phase: Phase 1
• Start date: November 28, 2011
• Est. completion date: December 31, 2012

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 31, 2012
• Est. primary completion date: December 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Lupus Nephritis
• Nephritis
• Systemic Lupus Erythematosus

Intervention

Drug:
• Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody
Intravenous injection

Locations

Country	Name	City	State
Australia	Austin Health	Heidelberg	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Linear Clinical Research Limited	Nedlands	Western Australia
Canada	CHUM Hôpital Saint-Luc	Montréal	Quebec
Canada	St. Paul´s Hospital	Saskatoon	Saskatchewan
Mexico	Hospital CIMA Chihuahua	Chihuahua
Mexico	Mexico Center for Clinical Research S.A de C.V	Mexico City	Distrito Federal
Mexico	Hospital Universitario Dr Jose Eleuterio Gonzalez	Monterrey	Nuevo León
Mexico	Hospital y Clinica OCA SA de CV	Monterrey	Nuevo León
Mexico	Clinica San Jose	Sonora	Obregon
New Zealand	Auckland City Hospital	Auckland
New Zealand	Middlemore Hospital	Auckland
United States	Northeast Clinical Research Center, LLC	Bethlehem	Pennsylvania
United States	IMMUNOe International Research Centers	Centennial	Colorado
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	UT Southwestern Medical Center at Dallas	Dallas	Texas
United States	University of Colorado	Denver	Colorado
United States	Academic Medical Research Institute Inc.	Los Angeles	California
United States	Mohamed A. El-Shahawy	Los Angeles	California
United States	Ramesh Gupta	Memphis	Tennessee
United States	Ramesh Gupta	Memphis	Tennessee
United States	Tulane University Hospital & Clinic	New Orleans	Louisiana
United States	Clinical Research Development Associates, LLC	Springfield Gardens	New York
United States	North Valley Nephrology	Yuba City	California

Sponsors (1)

Lead Sponsor	Collaborator
Baxalta now part of Shire

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Mexico,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality		Week 21
Secondary	Plasma pharmacokinetic parameters	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)	Week 21