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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01541670




Registration number
NCT01541670
Ethics application status
Date submitted
20/02/2012
Date registered
1/03/2012
Date last updated
23/10/2017

Titles & IDs
Public title
Safety Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Lupus Nephritis
Scientific title
A Study to Assess the Safety and Tolerability of Anti-MIF Antibody in Subjects With Lupus Nephritis
Secondary ID [1] 0 0
391001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody

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


Treatment: Drugs: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody
Intravenous injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality
Timepoint [1] 0 0
Week 21
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
Week 21

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any significant health problem other than lupus or lupus nephritis

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Austin Health - Heidelberg
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Linear Clinical Research Limited - Nedlands
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
3052 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Canada
State/province [10] 0 0
Saskatchewan
Country [11] 0 0
Mexico
State/province [11] 0 0
Distrito Federal
Country [12] 0 0
Mexico
State/province [12] 0 0
Nuevo León
Country [13] 0 0
Mexico
State/province [13] 0 0
Sonora
Country [14] 0 0
Mexico
State/province [14] 0 0
Chihuahua
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Baxalta now part of Shire
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in
subjects with lupus nephritis.
Trial website
https://clinicaltrials.gov/show/NCT01541670
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
BioScience Investigator
Address 0 0
Baxter Healthcare Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01541670