Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Functional MRI in Lupus Nephritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Biogen Idec
Information provided by (Responsible Party):
Biogen Idec Identifier:
First received: November 8, 2012
Last updated: January 31, 2014
Last verified: January 2014

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) subjects.

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 subjects with lupus nephritis (LN).

Lupus Nephritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Assessment Of Renal Activity And Damage Using Renal Functional MRI In Normal Healthy Volunteers And Subjects With Lupus Nephritis

Resource links provided by NLM:

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 subjects with lupus nephritis (LN). [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • 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: magnetic resonance imaging (MRI) within 7 days of renal biopsy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between histological renal activity and chronicity scores and renal functional magnetic resonance imaging (MRI) measurements in subjects with lupus nephritis (LN). [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Correlation between renal cortical volume and renal functional magnetic resonance imaging (MRI) measurements. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Correlation between renal functional magnetic resonance imaging (MRI) measurements and proteinuria. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood Samples, Urine samples and Renal biopsy tissue samples.

Estimated Enrollment: 80
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic, community sample. 30 Normal Healthy Volunteers 30 Subjects with documented diagnosis of Lupus Nephritis


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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01731054

Contact: Biogen-Idec Investigator

United States, California
Research Site Recruiting
Los Angeles, California, United States
United States, New York
Research Site Recruiting
New York, New York, United States
United States, Ohio
Research Site Recruiting
Columbus, Ohio, United States
Sponsors and Collaborators
Biogen Idec
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec Identifier: NCT01731054     History of Changes
Other Study ID Numbers: 999LE002
Study First Received: November 8, 2012
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board
United Kingdom: Research Ethics Committee

Keywords provided by Biogen Idec:
lupus nephritis
normal healthy volunteer

Additional relevant MeSH terms:
Lupus Nephritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Kidney Diseases
Lupus Erythematosus, Systemic
Urologic Diseases processed this record on March 03, 2015