Clinical trial NCT01541670: Safety Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Lupus Nephritis
Official title: A Study to Assess the Safety and Tolerability of Anti-MIF Antibody in Subjects With Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-03-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality
timeFrame: Week 21
Secondary outcomes:
measure: Plasma pharmacokinetic parameters
timeFrame: Week 21
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Academic Medical Research Institute Inc.
state: California
city: Los Angeles
country: United States
facility: Mohamed A. El-Shahawy
state: California
city: Yuba City
country: United States
facility: North Valley Nephrology
state: California
city: Centennial
country: United States
facility: IMMUNOe International Research Centers
state: Colorado
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: New Orleans
country: United States
facility: Tulane University Hospital & Clinic
state: Louisiana
city: Springfield Gardens
country: United States
facility: Clinical Research Development Associates, LLC
state: New York
city: Bethlehem
country: United States
facility: Northeast Clinical Research Center, LLC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Memphis
country: United States
facility: Ramesh Gupta
state: Tennessee
city: Memphis
country: United States
facility: Ramesh Gupta
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Linear Clinical Research Limited
state: Western Australia
city: Montréal
country: Canada
facility: CHUM Hôpital Saint-Luc
state: Quebec
city: Saskatoon
country: Canada
facility: St. Paul´s Hospital
state: Saskatchewan
city: Mexico City
country: Mexico
facility: Mexico Center for Clinical Research S.A de C.V
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Hospital y Clinica OCA SA de CV
state: Nuevo León
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez
state: Nuevo León
city: Sonora
country: Mexico
facility: Clinica San Jose
state: Obregon
city: Chihuahua
country: Mexico
facility: Hospital CIMA Chihuahua
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Auckland
country: New Zealand
facility: Middlemore Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: