|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 May 2021 |
|
Main ID: |
NCT01541670 |
|
Date of registration:
|
20/02/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
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 |
|
Date of first enrolment:
|
November 28, 2011 |
|
Target sample size:
|
4 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT01541670 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
Australia
|
Canada
|
Mexico
|
New Zealand
|
United States
| | | |
|
Contacts
|
|
Name:
|
Study Director |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Takeda |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Systemic Lupus Erythematosus
|
|
Intervention(s)
|
|
Drug: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody
|
|
Primary Outcome(s)
|
|
Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality
[Time Frame: Week 21]
|
|
Secondary Outcome(s)
|
|
Plasma pharmacokinetic parameters
[Time Frame: Week 21]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|