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
1 other identifier
interventional
4
5 countries
24
Brief Summary
The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2011
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 28, 2011
CompletedFirst Submitted
Initial submission to the registry
February 20, 2012
CompletedFirst Posted
Study publicly available on registry
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2012
CompletedMay 5, 2021
May 1, 2021
1.1 years
February 20, 2012
May 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality
Week 21
Secondary Outcomes (1)
Plasma pharmacokinetic parameters
Week 21
Study Arms (1)
Open-label Dose-Escalation Arm
EXPERIMENTALConducted in an ascending dose manner, subjects will be assigned to single- or multiple-dose administration of the investigational product
Interventions
Intravenous injection
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Any significant health problem other than lupus or lupus nephritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Academic Medical Research Institute Inc.
Los Angeles, California, 90022, United States
Mohamed A. El-Shahawy
Los Angeles, California, 90022, United States
North Valley Nephrology
Yuba City, California, 95991, United States
IMMUNOe International Research Centers
Centennial, Colorado, 80112, United States
University of Colorado
Denver, Colorado, 80220, United States
Tulane University Hospital & Clinic
New Orleans, Louisiana, 70112, United States
Clinical Research Development Associates, LLC
Springfield Gardens, New York, 11413, United States
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, 18017, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Ramesh Gupta
Memphis, Tennessee, 38016, United States
Ramesh Gupta
Memphis, Tennessee, 38119, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8523, United States
Austin Health
Heidelberg, Victoria, 3084, Australia
The Alfred Hospital
Melbourne, Victoria, 3052, Australia
Linear Clinical Research Limited
Nedlands, Western Australia, 6009, Australia
CHUM Hôpital Saint-Luc
Montreal, Quebec, H2X 3J4, Canada
St. Paul´s Hospital
Saskatoon, Saskatchewan, S7M 0Z9, Canada
Mexico Center for Clinical Research S.A de C.V
Mexico City, Mexico City, 3100, Mexico
Hospital y Clinica OCA SA de CV
Monterrey, Nuevo León, 64000, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460, Mexico
Clinica San Jose
Sonora, Obregon, 85000, Mexico
Hospital CIMA Chihuahua
Chihuahua City, 31238, Mexico
Auckland City Hospital
Auckland, 1071, New Zealand
Middlemore Hospital
Auckland, 1640, New Zealand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2012
First Posted
March 1, 2012
Study Start
November 28, 2011
Primary Completion
December 31, 2012
Study Completion
December 31, 2012
Last Updated
May 5, 2021
Record last verified: 2021-05