Brief Summary
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).
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).
Brief Title
Functional MRI in Lupus Nephritis
Completion Date
Completion Date Type
Actual
Conditions
Healthy
Lupus Nephritis
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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.
inclusion/
* 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.
inclusion/
Gender
All
Gender Based
false
Keywords
lupus nephritis
normal healthy volunteer
MRI
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
60 Years
Minimum Age
18 Years
NCT Id
NCT01731054
Org Class
Industry
Org Full Name
Biogen
Org Study Id
999LE002
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Noninvasive Assessment Of Renal Activity And Damage Using Renal Functional MRI In Normal Healthy Volunteers And Subjects With Lupus Nephritis
Primary Outcomes
Outcome Measure
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).
Outcome Time Frame
Day 1
Outcome Measure
The mean difference between normal healthy volunteers (NHV) and lupus nephiritis (LN) groups in renal structural and functional magnetic resonance imaging (MRI) measurements.
Outcome Time Frame
Within7 days of renal biopsy
Secondary Outcomes
Outcome Time Frame
Day 1
Outcome Measure
Correlation between histological renal activity and chronicity scores and renal functional magnetic resonance imaging (MRI) measurements in participants with lupus nephritis (LN).
Outcome Time Frame
Day 1
Outcome Measure
Correlation between renal cortical volume and renal functional magnetic resonance imaging (MRI) measurements.
Outcome Time Frame
Day 1
Outcome Measure
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.
Outcome Time Frame
Day 1
Outcome Measure
Correlation between renal functional magnetic resonance imaging (MRI) measurements and proteinuria.
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Primary care clinic, community sample. 30 Normal Healthy Volunteers 30 Participants with documented diagnosis of Lupus Nephritis
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
60
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Chaim Putterman
Investigator Email
chaim.putterman@einsteinmed.org
Investigator Phone
718-430-4266