Clinical trial NCT01731054: Functional MRI in Lupus Nephritis
Official title: Noninvasive Assessment Of Renal Activity And Damage Using Renal Functional MRI In Normal Healthy Volunteers And Subjects With Lupus Nephritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lupus Nephritis
Keywords: lupus nephritis
normal healthy volunteer
MRI
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic, community sample. 30 Normal Healthy Volunteers 30 Participants with documented diagnosis of Lupus Nephritis

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).


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.

Primary outcomes:
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).
timeFrame: Day 1
measure: The mean difference between normal healthy volunteers (NHV) and lupus nephiritis (LN) groups in renal structural and functional magnetic resonance imaging (MRI) measurements.
timeFrame: Within7 days of renal biopsy
Secondary outcomes:
measure: Correlation between histological renal activity and chronicity scores and renal functional magnetic resonance imaging (MRI) measurements in participants with lupus nephritis (LN).
timeFrame: Day 1
measure: Correlation between renal cortical volume and renal functional magnetic resonance imaging (MRI) measurements.
timeFrame: Day 1
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.
timeFrame: Day 1
measure: Correlation between renal functional magnetic resonance imaging (MRI) measurements and proteinuria.
timeFrame: Day 1
Other outcomes:
Locations:
city: Los Angelos
country: United States
facility: Research Site
state: California
city: Torrance
country: United States
facility: Research Site
state: California
city: Bronx
country: United States
facility: Research Site
state: New York
city: Columbus
country: United States
facility: Research Site
state: Ohio
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: