Functional MRI in Lupus Nephritis
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ClinicalTrials.gov Identifier: NCT01731054 |
Recruitment Status
:
Completed
First Posted
: November 21, 2012
Last Update Posted
: April 27, 2015
|
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The primary objectives of the study are as follows: To develop and optimize a renal functional magnetic resonance imaging (MRI) protocol consisting of Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), Blood-Oxygen- Level-Dependent MRI (BOLD-MRI), Arterial Spin Labeling MRI (ASL-MRI), Phase Contrast MRI (PC-MRI), and T1rho-MRI; To compare renal functional MRI cross-sectional readouts between normal healthy volunteers (NHV) and lupus nephritis (LN) participants.
The secondary objectives of this study are as follows: Explore whether renal functional MRI techniques discriminate between renal inflammatory activity and damage in lupus nephritis (LN); To examine whether renal functional MRI measurements correlate with laboratory features of renal involvement and renal function in participants with lupus nephritis (LN).
Condition or disease |
---|
Healthy Lupus Nephritis |
Study Type : | Observational |
Actual Enrollment : | 50 participants |
Observational Model: | Cohort |
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 |
Study Start Date : | June 2013 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | March 2015 |
- The test-retest reliability and sensitivity of renal functional magnetic resonance imaging (MRI) measurements to detect renal inflammatory activity or damage in normal healthy volunteers (NHV) and participants with lupus nephritis (LN). [ Time Frame: Day 1 ]
- The mean difference between normal healthy volunteers (NHV) and lupus nephiritis (LN) groups in renal structural and functional magnetic resonance imaging (MRI) measurements. [ Time Frame: Within7 days of renal biopsy ]
- Correlation between histological renal activity and chronicity scores and renal functional magnetic resonance imaging (MRI) measurements in participants with lupus nephritis (LN). [ Time Frame: Day 1 ]
- Correlation between renal cortical volume and renal functional magnetic resonance imaging (MRI) measurements. [ Time Frame: Day 1 ]
- Correlation between renal functional magnetic resonance imaging (MRI) measurements and renal function as assessed by estimated glomerular filtration rate (eGFR) using Modification of Diet in Renal Disease (MDRD) formula. [ Time Frame: Day 1 ]
- Correlation between renal functional magnetic resonance imaging (MRI) measurements and proteinuria. [ Time Frame: Day 1 ]
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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Key Inclusion Criteria:
- Must have a documented diagnosis of systemic lupus erythematosus (SLE) according to current American Academy of Rheumatology (ACR) criteria. At least 4 American Academy of Rheumatology (ACR) criteria must be documented, 1 of which must be a positive antinuclear antibody (ANA), anti-Sm, or anti-double stranded DNA antibody.
- Must have a standard of care renal biopsy for lupus nephritis performed or scheduled within +/-7 days of Day 1.
Key Exclusion Criteria:
- Has a metal device affected by magnetic resonance imaging (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 magnetic resonance imaging (MRI).
- History of renal transplant.
- Subjects with uncontrolled diabetes or other condition that may result in significant renal disease.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731054
United States, California | |
Research Site | |
Los Angelos, California, United States, 90095 | |
Research Site | |
Torrance, California, United States, 90502 | |
United States, New York | |
Research Site | |
Bronx, New York, United States, 10461 | |
United States, Ohio | |
Research Site | |
Columbus, Ohio, United States, 3210 |
Study Director: | Medical Director | Biogen |
Responsible Party: | Biogen |
ClinicalTrials.gov Identifier: | NCT01731054 History of Changes |
Other Study ID Numbers: |
999LE002 |
First Posted: | November 21, 2012 Key Record Dates |
Last Update Posted: | April 27, 2015 |
Last Verified: | March 2015 |
Keywords provided by Biogen:
lupus nephritis normal healthy volunteer MRI |
Additional relevant MeSH terms:
Nephritis Lupus Nephritis Kidney Diseases Urologic Diseases Glomerulonephritis |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |