Functional MRI in Lupus Nephritis

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731054
• Other study ID #: 999LE002
• Status: Completed
• Phase: N/A
• First received: November 8, 2012
• Last updated: April 23, 2015
• Start date: June 2013
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy
• Lupus Nephritis
• Nephritis

Locations

Country	Name	City	State
United States	Research Site	Bronx	New York
United States	Research Site	Columbus	Ohio
United States	Research Site	Los Angelos	California
United States	Research Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Correlation between histological renal activity and chronicity scores and renal functional magnetic resonance imaging (MRI) measurements in participants with lupus nephritis (LN).		Day 1	No
Secondary	Correlation between renal cortical volume and renal functional magnetic resonance imaging (MRI) measurements.		Day 1	No
Secondary	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	No
Secondary	Correlation between renal functional magnetic resonance imaging (MRI) measurements and proteinuria.		Day 1	No