Functional MRI in Lupus Nephritis
This study is not yet open for participant recruitment.
Verified November 2012 by Biogen Idec
Sponsor:
Biogen Idec
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01731054
First received: November 8, 2012
Last updated: November 16, 2012
Last verified: November 2012
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Purpose
The purpose of this study is to determine if functional MRI may be used as a biomarker of renal activity and/or damage in subjects with lupus nephritis.
| Condition |
|---|
|
Lupus Nephritis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Noninvasive Assessment Of Renal Activity And Damage Using Renal Functional MRI In Normal Healthy Volunteers And Subjects With Lupus Nephritis |
Further study details as provided by Biogen Idec:
Primary Outcome Measures:
- Develop and optimize a renal functional MRI protocol consisting of Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), Blood-Oxygen- Level-Dependent MRI (BOLD-MRI), Arterial Spin Labeling MRI (ASL-MRI), and T1rho-MRI. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
- Compare renal functional MRI cross-sectional readouts between normal healthy volunteers (NHV) and LN subjects. [ Time Frame: MRI within 7 days of renal biopsy ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The mean difference between NHV and LN groups in renal structural and functional MRI measurements. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
- The test-retest reliability and sensitivity of renal functional MRI measurements to detect renal inflammatory activity or damage in NHV and subjects with LN. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
Renal imaging by functional magnetic resonance imaging (MRI) has the ability to measure changes in the tissue associated with renal inflammatory activity and/or damage, namely changes in diffusion, perfusion, and oxygenation. Therefore, it may be a promising approach for the evaluation of LN and response to treatment. Thus, the ability to accurately and noninvasively evaluate these factors directly would aid in the treatment of LN.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Primary care clinic, community sample. 30 Normal Healthy Volunteers 30 Subjects with documented diagnosis of Lupus Nephritis
Criteria
Inclusion Criteria:
- Must have a documented diagnosis of SLE according to current ACR criteria. At least 4 ACR criteria must be documented, 1 of which must be a positive ANA, anti-Sm, or anti-dsDNA antibody.
- Must have a standard of care renal biopsy for LN performed or scheduled within +/-7 days of Day 1.
- Exclusion Criteria:
- Has a metal device affected by MRI (e.g., any type of electronic, mechanical, or magnetic implant; cardiac pacemaker; aneurysm clips; implanted cardiac defibrillator), or has potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) that would be a contraindication for MRI.
- History of renal transplant.
- Subjects with uncontrolled diabetes or other condition that may result in significant renal disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731054
Contacts
| Contact: Medical Director | immunologyclinicaltrials@biogenidec.com |
Locations
| United States, California | |
| Research Site | Not yet recruiting |
| Los Angeles, California, United States | |
| United States, Ohio | |
| Research Site | Active, not recruiting |
| Columbus, Ohio, United States | |
Sponsors and Collaborators
Biogen Idec
More Information
No publications provided
| Responsible Party: | Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT01731054 History of Changes |
| Other Study ID Numbers: | 999LE002 |
| Study First Received: | November 8, 2012 |
| Last Updated: | November 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Biogen Idec:
|
lupus nephritis normal healty volunteer MRI |
Additional relevant MeSH terms:
|
Lupus Nephritis Nephritis Glomerulonephritis Kidney Diseases Urologic Diseases |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013