Systemic Lupus ErythematosusPhase 1NCT01541670
Safety Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Lupus Nephritis
A Phase 1 study testing Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in people with Systemic Lupus Erythematosus, run by Baxalta now part of Shire at 24 sites in 5 countries.
Trial summary
The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 24 sitesin 5 countries
- Study dates
- 28 Nov 2011to 31 Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Any significant health problem other than lupus or lupus nephritis
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
United States12 sites
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, 18017
IMMUNOe International Research Centers
Centennial, Colorado, 80112
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8523
University of Colorado
Denver, Colorado, 80220
Academic Medical Research Institute Inc.
Los Angeles, California, 90022
Mohamed A. El-Shahawy
Los Angeles, California, 90022
Ramesh Gupta
Memphis, Tennessee, 38016
Ramesh Gupta
Memphis, Tennessee, 38119
Tulane University Hospital & Clinic
New Orleans, Louisiana, 70112
Clinical Research Development Associates, LLC
Springfield Gardens, New York, 11413
North Valley Nephrology
Yuba City, California, 95991
Mexico5 sites
Hospital CIMA Chihuahua
Chihuahua City, 31238
Mexico Center for Clinical Research S.A de C.V
Mexico City, Mexico City, 3100
Hospital y Clinica OCA SA de CV
Monterrey, Nuevo León, 64000
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460
Clinica San Jose
Sonora, Obregon, 85000
Australia3 sites
Austin Health
Heidelberg, Victoria, 3084
The Alfred Hospital
Melbourne, Victoria, 3052
Linear Clinical Research Limited
Nedlands, Western Australia, 6009
Canada2 sites
CHUM Hôpital Saint-Luc
Montreal, Quebec, H2X 3J4
St. Paul´s Hospital
Saskatoon, Saskatchewan, S7M 0Z9
New Zealand2 sites
Auckland City Hospital
Auckland, 1071
Middlemore Hospital
Auckland, 1640
About this study
Official title: A Study to Assess the Safety and Tolerability of Anti-MIF Antibody in Subjects With Lupus Nephritis
The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) AntibodyDrug
Intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Open-label Dose-Escalation Arm | Experimental | Conducted in an ascending dose manner, subjects will be assigned to single- or multiple-dose administration of the investigational product Receives: Drug: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality
Measured: Week 21
Secondary outcomes (1)
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)
Measured: Week 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study start28 Nov 2011
- Primary completion31 Dec 2012
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541670
- Sponsor's protocol ID
- 391001
- Status last verified
- May 2021
- First submitted
- 20 Feb 2012
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Safety and Tolerability of Anti-MIF Antibody in Subjects With Lupus Nephritis
- ClinicalTrials.gov ID
- NCT01541670
- Acronym / sponsor ID
- 391001
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2011 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 1 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label Dose-Escalation Arm | Experimental | Drug: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) AntibodyConducted in an ascending dose manner, subjects will be assigned to single- or multiple-dose administration of the investigational product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- Any significant health problem other than lupus or lupus nephritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) AntibodyIntravenous injection | Drug | Open-label Dose-Escalation Arm |
Primary outcome
Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality
Time frame: Week 21
1 secondary outcome
Plasma pharmacokinetic parameters
Time frame: Week 21
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in people with Systemic Lupus Erythematosus, run by Baxalta now part of Shire at 24 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Mexico, Australia, Canada, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects experiencing serious adverse events (SAEs) and/or adverse events (AEs) regardless of causality (time frame: Week 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.