Functional MRI in Lupus Nephritis
| Status: | Completed |
|---|---|
| Conditions: | Lupus, Nephrology |
| Therapuetic Areas: | Immunology / Infectious Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 2/8/2015 |
| Start Date: | June 2013 |
| End Date: | December 2014 |
| Contact: | Biogen-Idec Investigator |
| Email: | clinicaltrials@biogenidec.com |
Noninvasive Assessment Of Renal Activity And Damage Using Renal Functional MRI In Normal Healthy Volunteers And Subjects With Lupus Nephritis
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) subjects.
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 subjects with lupus nephritis (LN).
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) subjects.
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 subjects with lupus nephritis (LN).
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.
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