<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01731054</url>
  </required_header>
  <id_info>
    <org_study_id>999LE002</org_study_id>
    <nct_id>NCT01731054</nct_id>
  </id_info>
  <brief_title>Functional MRI in Lupus Nephritis</brief_title>
  <official_title>Noninvasive Assessment Of Renal Activity And Damage Using Renal Functional MRI In Normal Healthy Volunteers And Subjects With Lupus Nephritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biogen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biogen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of the study are as follows: To develop and optimize a renal&#xD;
      functional magnetic resonance imaging (MRI) protocol consisting of Diffusion-Weighted&#xD;
      Magnetic Resonance Imaging (DW-MRI), Blood-Oxygen- Level-Dependent MRI (BOLD-MRI), Arterial&#xD;
      Spin Labeling MRI (ASL-MRI), Phase Contrast MRI (PC-MRI), and T1rho-MRI; To compare renal&#xD;
      functional MRI cross-sectional readouts between normal healthy volunteers (NHV) and lupus&#xD;
      nephritis (LN) participants.&#xD;
&#xD;
      The secondary objectives of this study are as follows: Explore whether renal functional MRI&#xD;
      techniques discriminate between renal inflammatory activity and damage in lupus nephritis&#xD;
      (LN); To examine whether renal functional MRI measurements correlate with laboratory features&#xD;
      of renal involvement and renal function in participants with lupus nephritis (LN).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <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).</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The mean difference between normal healthy volunteers (NHV) and lupus nephiritis (LN) groups in renal structural and functional magnetic resonance imaging (MRI) measurements.</measure>
    <time_frame>Within7 days of renal biopsy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between histological renal activity and chronicity scores and renal functional magnetic resonance imaging (MRI) measurements in participants with lupus nephritis (LN).</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between renal cortical volume and renal functional magnetic resonance imaging (MRI) measurements.</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <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.</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between renal functional magnetic resonance imaging (MRI) measurements and proteinuria.</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Healthy</condition>
  <condition>Lupus Nephritis</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood Samples, Urine samples and Renal biopsy tissue samples.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care clinic, community sample. 30 Normal Healthy Volunteers 30 Participants with&#xD;
        documented diagnosis of Lupus Nephritis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Must have a documented diagnosis of systemic lupus erythematosus (SLE) according to&#xD;
             current American Academy of Rheumatology (ACR) criteria. At least 4 American Academy&#xD;
             of Rheumatology (ACR) criteria must be documented, 1 of which must be a positive&#xD;
             antinuclear antibody (ANA), anti-Sm, or anti-double stranded DNA antibody.&#xD;
&#xD;
          -  Must have a standard of care renal biopsy for lupus nephritis performed or scheduled&#xD;
             within +/-7 days of Day 1.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Has a metal device affected by magnetic resonance imaging (MRI )(e.g., any type of&#xD;
             electronic, mechanical, or magnetic implant; cardiac pacemaker; aneurysm clips;&#xD;
             implanted cardiac defibrillator), or has potential ferromagnetic foreign body (metal&#xD;
             slivers, metal shavings, other metal objects) that would be a contraindication for&#xD;
             magnetic resonance imaging (MRI).&#xD;
&#xD;
          -  History of renal transplant.&#xD;
&#xD;
          -  Subjects with uncontrolled diabetes or other condition that may result in significant&#xD;
             renal disease.&#xD;
&#xD;
        NOTE: Other protocol-defined inclusion/exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Biogen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angelos</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>3210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>April 23, 2015</last_update_submitted>
  <last_update_submitted_qc>April 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lupus nephritis</keyword>
  <keyword>normal healthy volunteer</keyword>
  <keyword>MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nephritis</mesh_term>
    <mesh_term>Lupus Nephritis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01731054
org study id: 999LE002
nct id: NCT01731054
lead sponsor: 
has dmc: No
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).
observational model: Cohort
time perspective: Prospective
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).
time frame: 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.
time frame: Within7 days of renal biopsy
measure: 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
measure: Correlation between renal cortical volume and renal functional magnetic resonance imaging (MRI) measurements.
time frame: 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.
time frame: Day 1
measure: Correlation between renal functional magnetic resonance imaging (MRI) measurements and proteinuria.
time frame: Day 1
Blood Samples, Urine samples and Renal biopsy tissue samples.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Biogen
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nephritis
mesh term: Lupus Nephritis