Functional MRI in Lupus Nephritis

Biogen50 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Healthy Lupus Nephritis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

Research Site

Los Angelos, California, United States

Research Site

Torrance, California, United States

Research Site

The Bronx, New York, United States

Research Site

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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