Functional MRI in Lupus Nephritis

Study Overview
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Brief Summary
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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).

Official Title
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Noninvasive Assessment Of Renal Activity And Damage Using Renal Functional MRI In Normal Healthy Volunteers And Subjects With Lupus Nephritis

Conditions
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Healthy, Lupus Nephritis

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | 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. |  | Within7 days of renal biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between histological renal activity and chronicity scores and renal functional magnetic resonance imaging (MRI) measurements in participants with lupus nephritis (LN). |  | Day 1 | 
| Correlation between renal cortical volume and renal functional magnetic resonance imaging (MRI) measurements. |  | 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. |  | Day 1 | 
| Correlation between renal functional magnetic resonance imaging (MRI) measurements and proteinuria. |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lupus nephritis, normal healthy volunteer, MRI