<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/NCT03021499</url>
  </required_header>
  <id_info>
    <org_study_id>AUR-VCS-2016-01</org_study_id>
    <nct_id>NCT03021499</nct_id>
  </id_info>
  <brief_title>Aurinia Renal Response in Active Lupus With Voclosporin</brief_title>
  <acronym>AURORA</acronym>
  <official_title>A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Voclosporin (23.7 mg Twice Daily) With Placebo in Achieving Renal Response in Subjects With Active Lupus Nephritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aurinia Pharmaceuticals Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aurinia Pharmaceuticals Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy of voclosporin compared with placebo in&#xD;
      achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the current study is to investigate whether voclosporin, added to the standard of&#xD;
      care treatment in active lupus nephritis (LN), is able to reduce disease activity over a&#xD;
      treatment period of 52 weeks. The background therapy will be mycophenolate mofetil (MMF) and&#xD;
      initial treatment with IV methylprednisolone, followed by a reducing course of oral&#xD;
      corticosteroids. Subjects with active, flaring LN will be eligible to enter the study. They&#xD;
      are required to have a diagnosis of LN according to established diagnostic criteria and&#xD;
      clinical and biopsy features suggestive of active nephritis. Efficacy will be assessed by the&#xD;
      ability of the drug combination to reduce the level of proteinuria (as measured by Urine&#xD;
      Protein Creatinine Ratio (UPCR)) while demonstrating an acceptable safety profile.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 17, 2017</start_date>
  <completion_date type="Actual">October 10, 2019</completion_date>
  <primary_completion_date type="Actual">September 24, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Adjudicated Renal Response at Week 52</measure>
    <time_frame>52 Weeks</time_frame>
    <description>The primary efficacy endpoint was the number of subjects showing renal response at Week 52. Renal response was adjudicated based on blinded data by an independent Clinical Endpoints Committee based on meeting the following criteria&#xD;
UPCR of ≤0.5 mg/mg &amp;&#xD;
eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of &gt;20% &amp;&#xD;
Received no rescue medication for LN &amp;&#xD;
Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during Weeks 44 through 52, prior to assessment Note:To be disqualified from renal response, the subject had to fail both eGFR measures (i.e., confirmed eGFR &lt;60 mL/min/1.73 m2 &amp; confirmed &gt;20% drop from baseline) &amp; have an associated treatment-related or disease-related AE that impacted eGFR Withdrawals prior to Week 52 with insufficient Week 52 data to determine response were defined non responders. Subjects who discontinued study drug but continued to attend study visits had their data assessed for response</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less</measure>
    <time_frame>52 Weeks</time_frame>
    <description>Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Urine Protein Creatinine Ratio of ≤0.5 mg/mg (Number of Days)</measure>
    <time_frame>52 Weeks</time_frame>
    <description>Time in days to reduction in Urine Protein Creatinine Ratio to decrease to 0.5 mg/mg or less.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Renal Response at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>Number of subjects showing renal response at Week 24. Renal response was adjudicated based on blinded data by an Independent Clinical Endpoints Committee based on the following criteria:&#xD;
UPCR of ≤0.5 mg/mg, &amp; eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of &gt;20%, and Received no rescue medication for LN &amp; Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during Weeks 16 through 24, just prior to the renal response assessment. Note:To be disqualified from renal response, the subject had to fail both eGFR measures (i.e., confirmed eGFR &lt;60 mL/min/1.73 m2 AND confirmed &gt;20% drop from BL) &amp; have an associated treatment-related or disease-related AE that impacted eGFR. Subjects who withdrew prior to the Week 24 assessment and provided insufficient Week 24 data to determine response were defined as non-responders. Subjects who discontinued study drug but continued to attend study visits had their data assessed for response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Partial Renal Response at Weeks 24 &amp; 52</measure>
    <time_frame>Weeks 24 and 52</time_frame>
    <description>Number of subjects with partial Renal Response (defined as a 50% reduction in UPCR from baseline) at Week 24 and at Week 52. Baseline UPCR is the average of 2 pre-randomisation values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Achieving, and Remaining in, Renal Response (Urine Protein Creatinine Ratio ≤0.5 mg/mg)</measure>
    <time_frame>Week 52</time_frame>
    <description>Number of subjects achieving, and remaining in, renal response (Urine Protein Creatinine ratio ≤0.5 mg/mg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Renal Response (Number of Days)</measure>
    <time_frame>Week 52</time_frame>
    <description>Duration in days until second occurrence of UPCR &gt;0.5 mg/mg in those subjects who achieve a reduction in UPCR to below 0.5 mg/mg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Achieving 50% Reduction in Urine Protein Creatinine Ratio</measure>
    <time_frame>52 Weeks</time_frame>
    <description>Number of subjects achieving 50% reduction in Urine Protein Creatinine ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to 50% Reduction in UPCR (Number of Days)</measure>
    <time_frame>52 weeks</time_frame>
    <description>Time in days to reduction in Urine Protein Creatinine Ratio to decrease by 50% compared to baseline. Baseline is the average of two pre-randomisation values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in eGFR</measure>
    <time_frame>Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.</time_frame>
    <description>Change from baseline by visit in estimated Glomerular Filtration rate. eGFR is corrected to a maximum value of 90 mL/min/1.73 m2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in UPCR</measure>
    <time_frame>Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.</time_frame>
    <description>Change from baseline by visit in Urine Protein Creatinine Ratio. Baseline is the average of two pre-randomisation values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Renal Response With Low Dose Steroids</measure>
    <time_frame>Week 24 and Week 52</time_frame>
    <description>Programmed Renal Response whilst on low dose steroids (&lt;2.5 mg/day) for the preceding 8 Weeks at Weeks 24 and 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA - SLEDAI)</measure>
    <time_frame>Week 24 and Week 52</time_frame>
    <description>Change from baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score at Week 24 and 52.&#xD;
The SELENA-SLEDAI tool is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-SLEDAI total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient Reported Outcomes</measure>
    <time_frame>Week 24 and Week 52</time_frame>
    <description>Health-related quality of life (HRQoL) information was collected using the Short Form Health Survey (SF-36) HRQoL assessment and the LupusPRO (v1.7) assessment.&#xD;
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. Scoring ranges from 0 to 100 with higher scores reflecting better health.&#xD;
LupusPro assessment is a patient-reported questionnaire regarding the effect of lupus or its treatment on the patient's health, quality of life, and the medical care received related to lupus. The questionnaire consists of 43 questions within 8 HRQOL domains and 4 Non-HRQoL domains. Scores range from 0 to 100 with higher scores reflecting better quality of life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">358</enrollment>
  <condition>Lupus Nephritis</condition>
  <arm_group>
    <arm_group_label>Voclosporin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral, 23.7 mg twice daily (BID)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Oral Capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Voclosporin placebo, oral, 3 capsules twice daily (BID)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Voclosporin</intervention_name>
    <description>calcineurin inhibitor</description>
    <arm_group_label>Voclosporin</arm_group_label>
    <other_name>ISA247</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Capsule</intervention_name>
    <description>matching placebo capsule</description>
    <arm_group_label>Placebo Oral Capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
        - Subjects with evidence of active nephritis, defined as follows:&#xD;
&#xD;
          -  Kidney biopsy result within 2 years prior to screening indicating Class III, IV-S,&#xD;
             IV-G (alone or in combination with Class V), or Class V LN with a doubling or greater&#xD;
             increase of UPCR within the last 6 months to a minimum of ≥1.5 mg/mg for Class III/IV&#xD;
             or to a minimum of ≥2 mg/mg for Class V at screening. Biopsy results over 6 months&#xD;
             prior to screening must be reviewed with a medical monitor to confirm eligibility.&#xD;
&#xD;
        OR&#xD;
&#xD;
          -  Kidney biopsy result within 6 months prior to screening indicating Class III, IV-S or&#xD;
             IV-G (alone or in combination with Class V) LN with a UPCR of ≥1.5 mg/mg at screening.&#xD;
&#xD;
        OR&#xD;
&#xD;
          -  Kidney biopsy result within 6 months prior to screening indicating Class V LN and a&#xD;
             UPCR of ≥2 mg/mg at screening.&#xD;
&#xD;
               -  Women of childbearing potential must have a negative serum pregnancy test at&#xD;
                  screening and a negative urine pregnancy test at baseline.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR) of ≤45 mL/minute at screening.&#xD;
&#xD;
          -  Current or medical history of:&#xD;
&#xD;
               -  Congenital or acquired immunodeficiency.&#xD;
&#xD;
               -  In the opinion of the Investigator, clinically significant drug or alcohol abuse&#xD;
                  within 2 years prior to screening.&#xD;
&#xD;
               -  Malignancy within 5 years of screening, with the exception of basal and squamous&#xD;
                  cell carcinomas treated by complete excision.&#xD;
&#xD;
               -  Lymphoproliferative disease or previous total lymphoid irradiation.&#xD;
&#xD;
               -  Severe viral infection or known HIV infection.&#xD;
&#xD;
               -  Active tuberculosis (TB), or known history of TB/evidence of old TB if not taking&#xD;
                  prophylaxis with isoniazid.&#xD;
&#xD;
          -  Other known clinically significant active medical conditions, such as:&#xD;
&#xD;
               -  Severe cardiovascular disease, liver dysfunction or chronic obstructive pulmonary&#xD;
                  disease or asthma requiring oral steroids or any other overlapping autoimmune&#xD;
                  condition for which the condition or the treatment of the condition may affect&#xD;
                  the study assessments or outcomes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samir Parikh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Thousand Oaks</city>
        <state>California</state>
        <zip>91360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>DeBary</city>
        <state>Florida</state>
        <zip>32713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201-2017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Grand Blanc</city>
        <state>Michigan</state>
        <zip>48439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021-4823</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>11203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>New Bern</city>
        <state>North Carolina</state>
        <zip>28562</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Hendersonville</city>
        <state>Tennessee</state>
        <zip>37075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Beaumont</city>
        <state>Texas</state>
        <zip>77036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79935</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Arlington</city>
        <state>Virginia</state>
        <zip>22205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Caba</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Córdoba</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>La Plata</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>San Miguel De Tucumán</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Cener</name>
      <address>
        <city>Minsk</city>
        <zip>220116</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Minsk</city>
        <zip>223040</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Vitebsk</city>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Curitiba</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Porto Alegre</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Salvador</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Plovdiv</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Smolyan</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Stara Zagora</city>
        <zip>6001</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Vidin</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Temuco</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Valdivia</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Barranquilla</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Bogotá</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Bucaramanga</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Zipaquirá</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>San José</city>
        <zip>10108</zip>
        <country>Costa Rica</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>San José</city>
        <country>Costa Rica</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Osijek</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Zagreb</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Santiago de los Caballeros</city>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Santo Domingo</city>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Guatemala City</city>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Kita</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Ishikawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Kitakyushu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Kita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Maebashi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Nagasaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Niigata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Sapporo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Sendai</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Suwon-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Wŏnju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>50586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Baja California</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Coahuila</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Guadalajara</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>León</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Mexico City</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Monclova</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Mérida</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Oaxaca</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>San Luis Potosí</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Sinaloa</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Leiden</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Skopje</city>
        <zip>1000</zip>
        <country>North Macedonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Trujillo</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Angeles City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Davao City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Lipa</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Manila</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Quezon City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Wrocław</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>San Juan</city>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Kazan</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Kemerovo</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Krasnoyarsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Omsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Petrozavodsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Rostov-on-Don</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Samara</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Saratov</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Tol'yatti</city>
        <zip>445009</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150062</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Yekaterinburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Niš</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Cape town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Johannesburg</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Pretoria</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Stellenbosch</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>A Coruña</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Chang Hua</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Chang-hua</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Taoyuan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Chiang Mai</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Songkhla</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Balcalı</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Bursa</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Efeler</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Fatih</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>İstanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Konyaalti</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Malatya</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Yenimahalle</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Kharkiv</city>
        <zip>61103</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Kyiv</city>
        <zip>02125</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Luts'k</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Odessa</city>
        <zip>65025</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Vinnytsya</city>
        <zip>21018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Zaporizhzhya</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Hanoi</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AURORA Investigative Center</name>
      <address>
        <city>Ho Chi Minh City</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Belarus</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>Costa Rica</country>
    <country>Croatia</country>
    <country>Dominican Republic</country>
    <country>Guatemala</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>North Macedonia</country>
    <country>Peru</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United States</country>
    <country>Vietnam</country>
  </location_countries>
  <removed_countries>
    <country>Macedonia, The Former Yugoslav Republic of</country>
  </removed_countries>
  <reference>
    <citation>Rovin BH, Parikh SV, Hebert LA, Chan TM, Mok CC, Ginzler EM, Hooi LS, Brunetta P, Maciuca R, Solomons N. Lupus nephritis: induction therapy in severe lupus nephritis--should MMF be considered the drug of choice? Clin J Am Soc Nephrol. 2013 Jan;8(1):147-53. doi: 10.2215/CJN.03290412. Epub 2012 Aug 9.</citation>
    <PMID>22879439</PMID>
  </reference>
  <reference>
    <citation>Ling SY, Huizinga RB, Mayo PR, Larouche R, Freitag DG, Aspeslet LJ, Foster RT. Cytochrome P450 3A and P-glycoprotein drug-drug interactions with voclosporin. Br J Clin Pharmacol. 2014 Jun;77(6):1039-50. doi: 10.1111/bcp.12309.</citation>
    <PMID>24330024</PMID>
  </reference>
  <reference>
    <citation>Ling SY, Huizinga RB, Mayo PR, Freitag DG, Aspeslet LJ, Foster RT. Pharmacokinetics of voclosporin in renal impairment and hepatic impairment. J Clin Pharmacol. 2013 Dec;53(12):1303-12. doi: 10.1002/jcph.166. Epub 2013 Oct 8.</citation>
    <PMID>23996158</PMID>
  </reference>
  <reference>
    <citation>Mayo PR, Huizinga RB, Ling SY, Freitag DG, Aspeslet LJ, Foster RT. Voclosporin food effect and single oral ascending dose pharmacokinetic and pharmacodynamic studies in healthy human subjects. J Clin Pharmacol. 2013 Aug;53(8):819-26. doi: 10.1002/jcph.114. Epub 2013 Jun 4.</citation>
    <PMID>23736966</PMID>
  </reference>
  <results_reference>
    <citation>Dooley MA, Jayne D, Ginzler EM, Isenberg D, Olsen NJ, Wofsy D, Eitner F, Appel GB, Contreras G, Lisk L, Solomons N; ALMS Group. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. N Engl J Med. 2011 Nov 17;365(20):1886-95. doi: 10.1056/NEJMoa1014460.</citation>
    <PMID>22087680</PMID>
  </results_reference>
  <results_reference>
    <citation>Busque S, Cantarovich M, Mulgaonkar S, Gaston R, Gaber AO, Mayo PR, Ling S, Huizinga RB, Meier-Kriesche HU; PROMISE Investigators. The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation. Am J Transplant. 2011 Dec;11(12):2675-84. doi: 10.1111/j.1600-6143.2011.03763.x. Epub 2011 Sep 22.</citation>
    <PMID>21943027</PMID>
  </results_reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <results_first_submitted>February 25, 2021</results_first_submitted>
  <results_first_submitted_qc>May 21, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 16, 2021</results_first_posted>
  <last_update_submitted>March 23, 2023</last_update_submitted>
  <last_update_submitted_qc>March 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lupus nephritis</keyword>
  <keyword>calcineurin inhibitors</keyword>
  <keyword>voclosporin</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol: Protocol V1.0 01Dec2016</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03021499/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Protocol V2.0 04May2017</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 4, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03021499/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 21, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03021499/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Eligible subjects were randomized in a ratio of 1:1 to receive either voclosporin 23.7 mg twice daily (BID) or matching placebo for 52 weeks. All subjects were also to receive 2 g/day mycophenolate mofetil (MMF). In addition, all subjects were to receive 0.5 g/day intravenous (IV) methylprednisolone on Days 1 and 2 before changing to a reducing course of oral corticosteroid therapy on Day 3.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Voclosporin</title>
          <description>Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="179"/>
                <participants group_id="P2" count="178"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Week 24</title>
              <participants_list>
                <participants group_id="P1" count="167"/>
                <participants group_id="P2" count="162"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Week 52</title>
              <participants_list>
                <participants group_id="P1" count="162"/>
                <participants group_id="P2" count="147"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="163"/>
                <participants group_id="P2" count="147"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Prohibited medication required</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>None of the above</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event (AE) Prior to First Dose</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-Treat is comprised of all subjects who were randomized treatment, and was used for analysis of all Outcome Measures. Safety population comprised all randomized subjects who took at least one dose of study treatment, and was used for AE and SAE reporting. 1 Voclosporin subject was withdrawn due to an adverse event (AE) prior to receiving the first dose of Voclosporin.</population>
      <group_list>
        <group group_id="B1">
          <title>Voclosporin</title>
          <description>oral, 23.7 mg BID&#xD;
Voclosporin: calcineurin inhibitor</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Voclosporin placebo, oral, 3 capsules BID&#xD;
Placebo: matching placebo capsule</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="179"/>
            <count group_id="B2" value="178"/>
            <count group_id="B3" value="357"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.8" spread="10.93"/>
                    <measurement group_id="B2" value="33.6" spread="11"/>
                    <measurement group_id="B3" value="33.2" spread="10.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="161"/>
                    <measurement group_id="B2" value="152"/>
                    <measurement group_id="B3" value="313"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="122"/>
                    <measurement group_id="B2" value="118"/>
                    <measurement group_id="B3" value="240"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="129"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>South Africa is included in the Europe count</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Southeast Asia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Europe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South America</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lupus Nephritis (LN) history</title>
          <description>Number of years since diagnosis of systemic lupus erythematosus (SLE), lupus nephritis (LN) and first significant proteinuria</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Years since diagnosis of systemic lupus erythematosus (SLE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.6" spread="6.41"/>
                    <measurement group_id="B2" value="6.9" spread="6.07"/>
                    <measurement group_id="B3" value="6.7" spread="6.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Years since diagnosis of LN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.6" spread="5.07"/>
                    <measurement group_id="B2" value="4.7" spread="4.89"/>
                    <measurement group_id="B3" value="4.6" spread="4.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Years since first Proteinuria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.8" spread="5.2"/>
                    <measurement group_id="B2" value="4.6" spread="4.51"/>
                    <measurement group_id="B3" value="4.7" spread="4.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Urine Protein Creatinine Ratio (UPCR)</title>
          <description>Baseline Urine Protein Creatinine Ratio (UPCR) (Average of pre-randomisation values)</description>
          <units>mg/mg</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.14" spread="2.711"/>
                    <measurement group_id="B2" value="3.87" spread="2.363"/>
                    <measurement group_id="B3" value="4.00" spread="2.537"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline estimated glomerular filtration rate (eGFR)</title>
          <description>Baseline estimated Glomerular Filtration Rate Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi formula) (lowest pre-randomisation value)</description>
          <units>mL/min/1.73 m2</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="92.1" spread="30.06"/>
                    <measurement group_id="B2" value="90.4" spread="28.97"/>
                    <measurement group_id="B3" value="91.2" spread="29.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adjudicated Renal Response at Week 52</title>
        <description>The primary efficacy endpoint was the number of subjects showing renal response at Week 52. Renal response was adjudicated based on blinded data by an independent Clinical Endpoints Committee based on meeting the following criteria&#xD;
UPCR of ≤0.5 mg/mg &amp;&#xD;
eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of &gt;20% &amp;&#xD;
Received no rescue medication for LN &amp;&#xD;
Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during Weeks 44 through 52, prior to assessment Note:To be disqualified from renal response, the subject had to fail both eGFR measures (i.e., confirmed eGFR &lt;60 mL/min/1.73 m2 &amp; confirmed &gt;20% drop from baseline) &amp; have an associated treatment-related or disease-related AE that impacted eGFR Withdrawals prior to Week 52 with insufficient Week 52 data to determine response were defined non responders. Subjects who discontinued study drug but continued to attend study visits had their data assessed for response</description>
        <time_frame>52 Weeks</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Voclosporin</title>
            <description>oral, 23.7 mg BID&#xD;
Voclosporin: calcineurin inhibitor</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Voclosporin placebo, oral, 3 capsules BID&#xD;
Placebo Oral Capsule: matching placebo capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adjudicated Renal Response at Week 52</title>
          <description>The primary efficacy endpoint was the number of subjects showing renal response at Week 52. Renal response was adjudicated based on blinded data by an independent Clinical Endpoints Committee based on meeting the following criteria&#xD;
UPCR of ≤0.5 mg/mg &amp;&#xD;
eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of &gt;20% &amp;&#xD;
Received no rescue medication for LN &amp;&#xD;
Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during Weeks 44 through 52, prior to assessment Note:To be disqualified from renal response, the subject had to fail both eGFR measures (i.e., confirmed eGFR &lt;60 mL/min/1.73 m2 &amp; confirmed &gt;20% drop from baseline) &amp; have an associated treatment-related or disease-related AE that impacted eGFR Withdrawals prior to Week 52 with insufficient Week 52 data to determine response were defined non responders. Subjects who discontinued study drug but continued to attend study visits had their data assessed for response</description>
          <population>Intent to Treat</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of renal responders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of renal non-responders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The primary endpoint was the proportion of subjects showing renal response at Week 52 as adjudicated by the Clinical Endpoints Committee.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <method_desc>The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and Region.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.64</ci_lower_limit>
            <ci_upper_limit>4.27</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less</title>
        <description>Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less</description>
        <time_frame>52 Weeks</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Voclosporin</title>
            <description>Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less</title>
          <description>Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less</description>
          <population>Intent to Treat</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects with UPCR ≤ 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects without UPCR ≤ 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>2.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.51</ci_lower_limit>
            <ci_upper_limit>2.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Urine Protein Creatinine Ratio of ≤0.5 mg/mg (Number of Days)</title>
        <description>Time in days to reduction in Urine Protein Creatinine Ratio to decrease to 0.5 mg/mg or less.</description>
        <time_frame>52 Weeks</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Voclosporin</title>
            <description>Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Urine Protein Creatinine Ratio of ≤0.5 mg/mg (Number of Days)</title>
          <description>Time in days to reduction in Urine Protein Creatinine Ratio to decrease to 0.5 mg/mg or less.</description>
          <population>Intent to Treat</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169" lower_limit="141" upper_limit="214"/>
                    <measurement group_id="O2" value="372" lower_limit="295" upper_limit="NA">Upper limit not calculated due to censored data</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Renal Response at Week 24</title>
        <description>Number of subjects showing renal response at Week 24. Renal response was adjudicated based on blinded data by an Independent Clinical Endpoints Committee based on the following criteria:&#xD;
UPCR of ≤0.5 mg/mg, &amp; eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of &gt;20%, and Received no rescue medication for LN &amp; Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during Weeks 16 through 24, just prior to the renal response assessment. Note:To be disqualified from renal response, the subject had to fail both eGFR measures (i.e., confirmed eGFR &lt;60 mL/min/1.73 m2 AND confirmed &gt;20% drop from BL) &amp; have an associated treatment-related or disease-related AE that impacted eGFR. Subjects who withdrew prior to the Week 24 assessment and provided insufficient Week 24 data to determine response were defined as non-responders. Subjects who discontinued study drug but continued to attend study visits had their data assessed for response.</description>
        <time_frame>Week 24</time_frame>
        <population>intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Voclosporin</title>
            <description>Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Renal Response at Week 24</title>
          <description>Number of subjects showing renal response at Week 24. Renal response was adjudicated based on blinded data by an Independent Clinical Endpoints Committee based on the following criteria:&#xD;
UPCR of ≤0.5 mg/mg, &amp; eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of &gt;20%, and Received no rescue medication for LN &amp; Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during Weeks 16 through 24, just prior to the renal response assessment. Note:To be disqualified from renal response, the subject had to fail both eGFR measures (i.e., confirmed eGFR &lt;60 mL/min/1.73 m2 AND confirmed &gt;20% drop from BL) &amp; have an associated treatment-related or disease-related AE that impacted eGFR. Subjects who withdrew prior to the Week 24 assessment and provided insufficient Week 24 data to determine response were defined as non-responders. Subjects who discontinued study drug but continued to attend study visits had their data assessed for response.</description>
          <population>intent to Treat</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of renal responders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of renal non-responders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121"/>
                    <measurement group_id="O2" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Regression, Cox</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.34</ci_lower_limit>
            <ci_upper_limit>3.72</ci_upper_limit>
            <estimate_desc>The hazard ratios are from a Cox's proportional hazards model with terms for treatment arm, baseline UPCR, biopsy class, MMF use at baseline and Region</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Partial Renal Response at Weeks 24 &amp; 52</title>
        <description>Number of subjects with partial Renal Response (defined as a 50% reduction in UPCR from baseline) at Week 24 and at Week 52. Baseline UPCR is the average of 2 pre-randomisation values.</description>
        <time_frame>Weeks 24 and 52</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Voclosporin</title>
            <description>Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Partial Renal Response at Weeks 24 &amp; 52</title>
          <description>Number of subjects with partial Renal Response (defined as a 50% reduction in UPCR from baseline) at Week 24 and at Week 52. Baseline UPCR is the average of 2 pre-randomisation values.</description>
          <population>Intent to Treat</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126"/>
                    <measurement group_id="O2" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125"/>
                    <measurement group_id="O2" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Week 24</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.56</ci_lower_limit>
            <ci_upper_limit>3.79</ci_upper_limit>
            <estimate_desc>Week 24</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 52</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Week 52</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.45</ci_lower_limit>
            <ci_upper_limit>3.51</ci_upper_limit>
            <estimate_desc>Week 52</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Achieving, and Remaining in, Renal Response (Urine Protein Creatinine Ratio ≤0.5 mg/mg)</title>
        <description>Number of subjects achieving, and remaining in, renal response (Urine Protein Creatinine ratio ≤0.5 mg/mg)</description>
        <time_frame>Week 52</time_frame>
        <population>Intent to Treat population achieving UPCR &lt;0.5 mg/mg</population>
        <group_list>
          <group group_id="O1">
            <title>Voclosporin</title>
            <description>Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Achieving, and Remaining in, Renal Response (Urine Protein Creatinine Ratio ≤0.5 mg/mg)</title>
          <description>Number of subjects achieving, and remaining in, renal response (Urine Protein Creatinine ratio ≤0.5 mg/mg)</description>
          <population>Intent to Treat population achieving UPCR &lt;0.5 mg/mg</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects achieving UPCR ≤ 0.5 mg/mg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>number with 2nd occurrence of UPCR &gt; 0.5 mg/mg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>number without 2nd occurrence of UPCR &gt; 0.5 mg/mg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.349</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.646</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Renal Response (Number of Days)</title>
        <description>Duration in days until second occurrence of UPCR &gt;0.5 mg/mg in those subjects who achieve a reduction in UPCR to below 0.5 mg/mg</description>
        <time_frame>Week 52</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Voclosporin</title>
            <description>Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Renal Response (Number of Days)</title>
          <description>Duration in days until second occurrence of UPCR &gt;0.5 mg/mg in those subjects who achieve a reduction in UPCR to below 0.5 mg/mg</description>
          <population>Intent to Treat</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="216" lower_limit="127" upper_limit="NA">Upper limit not calculated due to censored data</measurement>
                    <measurement group_id="O2" value="198" lower_limit="103" upper_limit="NA">Upper limit not calculated due to censored data</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Achieving 50% Reduction in Urine Protein Creatinine Ratio</title>
        <description>Number of subjects achieving 50% reduction in Urine Protein Creatinine ratio</description>
        <time_frame>52 Weeks</time_frame>
        <population>Intent-to-Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Voclosporin</title>
            <description>Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Achieving 50% Reduction in Urine Protein Creatinine Ratio</title>
          <description>Number of subjects achieving 50% reduction in Urine Protein Creatinine ratio</description>
          <population>Intent-to-Treat</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects with 50% UPCR reduction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="173"/>
                    <measurement group_id="O2" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects without 50% UPCR reduction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to 50% Reduction in UPCR (Number of Days)</title>
        <description>Time in days to reduction in Urine Protein Creatinine Ratio to decrease by 50% compared to baseline. Baseline is the average of two pre-randomisation values.</description>
        <time_frame>52 weeks</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Voclosporin</title>
            <description>Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
        </group_list>
        <measure>
          <title>Time to 50% Reduction in UPCR (Number of Days)</title>
          <description>Time in days to reduction in Urine Protein Creatinine Ratio to decrease by 50% compared to baseline. Baseline is the average of two pre-randomisation values.</description>
          <population>Intent to Treat</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29" lower_limit="29" upper_limit="32"/>
                    <measurement group_id="O2" value="63" lower_limit="57" upper_limit="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>2.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.62</ci_lower_limit>
            <ci_upper_limit>2.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in eGFR</title>
        <description>Change from baseline by visit in estimated Glomerular Filtration rate. eGFR is corrected to a maximum value of 90 mL/min/1.73 m2</description>
        <time_frame>Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Voclosporin</title>
            <description>Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in eGFR</title>
          <description>Change from baseline by visit in estimated Glomerular Filtration rate. eGFR is corrected to a maximum value of 90 mL/min/1.73 m2</description>
          <population>Intent to Treat</population>
          <units>ml/min/1.73 square metres</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.3" spread="15.83"/>
                    <measurement group_id="O2" value="77.4" spread="16.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="9.44"/>
                    <measurement group_id="O2" value="3.3" spread="10.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="10.39"/>
                    <measurement group_id="O2" value="3.2" spread="9.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="13.1"/>
                    <measurement group_id="O2" value="3.8" spread="11.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="11.74"/>
                    <measurement group_id="O2" value="3.3" spread="12.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="12.27"/>
                    <measurement group_id="O2" value="2.8" spread="13.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="12.09"/>
                    <measurement group_id="O2" value="3.2" spread="13.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="13.8"/>
                    <measurement group_id="O2" value="2.8" spread="13.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 30 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="14.2"/>
                    <measurement group_id="O2" value="1.8" spread="14.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" spread="14.89"/>
                    <measurement group_id="O2" value="1.5" spread="14.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 42 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" spread="16.7"/>
                    <measurement group_id="O2" value="1.5" spread="15.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.6" spread="17.2"/>
                    <measurement group_id="O2" value="1.1" spread="15.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="16.16"/>
                    <measurement group_id="O2" value="1.5" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-4.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.39</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.3</ci_lower_limit>
            <ci_upper_limit>-1.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.014</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-3.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.39</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.1</ci_lower_limit>
            <ci_upper_limit>-0.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-4.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.39</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.3</ci_lower_limit>
            <ci_upper_limit>-1.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 12</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.017</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-3.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.39</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6</ci_lower_limit>
            <ci_upper_limit>-0.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 16</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.085</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-2.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.4</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.1</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 20</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.035</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.4</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.7</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.121</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-2.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5</ci_lower_limit>
            <ci_upper_limit>0.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 30</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.12</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-2.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.42</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5</ci_lower_limit>
            <ci_upper_limit>0.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 36</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.102</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-2.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.43</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.1</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 42</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.022</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-3.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.44</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.1</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 48</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-4.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.45</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7</ci_lower_limit>
            <ci_upper_limit>-1.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 52</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.055</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-2.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.46</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.7</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in UPCR</title>
        <description>Change from baseline by visit in Urine Protein Creatinine Ratio. Baseline is the average of two pre-randomisation values.</description>
        <time_frame>Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Voclosporin</title>
            <description>Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in UPCR</title>
          <description>Change from baseline by visit in Urine Protein Creatinine Ratio. Baseline is the average of two pre-randomisation values.</description>
          <population>Intent to Treat</population>
          <units>mg/mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.14" spread="2.711"/>
                    <measurement group_id="O2" value="3.87" spread="2.363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.46" spread="1.991"/>
                    <measurement group_id="O2" value="-0.7" spread="2.312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.98" spread="2.29"/>
                    <measurement group_id="O2" value="-1.07" spread="2.155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.23" spread="2.213"/>
                    <measurement group_id="O2" value="-1.43" spread="2.448"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.56" spread="2.293"/>
                    <measurement group_id="O2" value="-1.48" spread="2.688"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.75" spread="2.462"/>
                    <measurement group_id="O2" value="-1.58" spread="2.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.74" spread="2.968"/>
                    <measurement group_id="O2" value="-1.54" spread="2.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.74" spread="2.567"/>
                    <measurement group_id="O2" value="-1.59" spread="2.899"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 30 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.66" spread="3.336"/>
                    <measurement group_id="O2" value="-1.7" spread="3.112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.74" spread="2.871"/>
                    <measurement group_id="O2" value="-1.63" spread="3.188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 42 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.91" spread="2.522"/>
                    <measurement group_id="O2" value="-1.78" spread="3.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.71" spread="2.807"/>
                    <measurement group_id="O2" value="-1.8" spread="3.004"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.65" spread="2.872"/>
                    <measurement group_id="O2" value="-1.88" spread="3.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.011</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-0.56</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.181</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1</ci_lower_limit>
            <ci_upper_limit>-0.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-0.76</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.187</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.13</ci_lower_limit>
            <ci_upper_limit>-0.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.181</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.05</ci_lower_limit>
            <ci_upper_limit>-0.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 12</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-0.94</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.196</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.33</ci_lower_limit>
            <ci_upper_limit>-0.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 16</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-1.18</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.214</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>-0.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 20</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-1.16</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.241</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.63</ci_lower_limit>
            <ci_upper_limit>-0.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-1.15</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.222</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.59</ci_lower_limit>
            <ci_upper_limit>-0.72</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 30</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-1.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.284</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.58</ci_lower_limit>
            <ci_upper_limit>-0.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 36</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-1.21</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.264</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.73</ci_lower_limit>
            <ci_upper_limit>-0.69</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 42</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-1.37</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.256</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.87</ci_lower_limit>
            <ci_upper_limit>-0.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 48</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-1.06</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.256</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.56</ci_lower_limit>
            <ci_upper_limit>-0.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 52</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-0.99</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.27</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.52</ci_lower_limit>
            <ci_upper_limit>-0.46</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Renal Response With Low Dose Steroids</title>
        <description>Programmed Renal Response whilst on low dose steroids (&lt;2.5 mg/day) for the preceding 8 Weeks at Weeks 24 and 52</description>
        <time_frame>Week 24 and Week 52</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Voclosporin</title>
            <description>Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Renal Response With Low Dose Steroids</title>
          <description>Programmed Renal Response whilst on low dose steroids (&lt;2.5 mg/day) for the preceding 8 Weeks at Weeks 24 and 52</description>
          <population>Intent to Treat</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Renal Response at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal Response at Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.008</p_value>
            <p_value_desc>Week 24</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.26</ci_lower_limit>
            <ci_upper_limit>4.71</ci_upper_limit>
            <estimate_desc>Week 24</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 52</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Week 52</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.48</ci_lower_limit>
            <ci_upper_limit>4.00</ci_upper_limit>
            <estimate_desc>Week 52</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA - SLEDAI)</title>
        <description>Change from baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score at Week 24 and 52.&#xD;
The SELENA-SLEDAI tool is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-SLEDAI total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.</description>
        <time_frame>Week 24 and Week 52</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Voclosporin</title>
            <description>Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA - SLEDAI)</title>
          <description>Change from baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score at Week 24 and 52.&#xD;
The SELENA-SLEDAI tool is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-SLEDAI total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.</description>
          <population>Intent to Treat</population>
          <units>scores on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from baseline at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.5" lower_limit="-5.4" upper_limit="-3.7"/>
                    <measurement group_id="O2" value="-4.1" lower_limit="-5.0" upper_limit="-3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline at Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6" lower_limit="-6.7" upper_limit="-5.2"/>
                    <measurement group_id="O2" value="-5.5" lower_limit="-6.3" upper_limit="-4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.373</p_value>
            <p_value_desc>Week 24</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Least Squares Mean difference</param_type>
            <param_value>-0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>0.6</ci_upper_limit>
            <estimate_desc>Week 24</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 52</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.277</p_value>
            <p_value_desc>Week 52</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Least Squares Mean difference</param_type>
            <param_value>-0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.4</ci_lower_limit>
            <ci_upper_limit>0.4</ci_upper_limit>
            <estimate_desc>Week 52</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient Reported Outcomes</title>
        <description>Health-related quality of life (HRQoL) information was collected using the Short Form Health Survey (SF-36) HRQoL assessment and the LupusPRO (v1.7) assessment.&#xD;
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. Scoring ranges from 0 to 100 with higher scores reflecting better health.&#xD;
LupusPro assessment is a patient-reported questionnaire regarding the effect of lupus or its treatment on the patient's health, quality of life, and the medical care received related to lupus. The questionnaire consists of 43 questions within 8 HRQOL domains and 4 Non-HRQoL domains. Scores range from 0 to 100 with higher scores reflecting better quality of life.</description>
        <time_frame>Week 24 and Week 52</time_frame>
        <population>Intent to Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Voclosporin</title>
            <description>Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
          <group group_id="O2">
            <title>Placebo Oral Capsule</title>
            <description>Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient Reported Outcomes</title>
          <description>Health-related quality of life (HRQoL) information was collected using the Short Form Health Survey (SF-36) HRQoL assessment and the LupusPRO (v1.7) assessment.&#xD;
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. Scoring ranges from 0 to 100 with higher scores reflecting better health.&#xD;
LupusPro assessment is a patient-reported questionnaire regarding the effect of lupus or its treatment on the patient's health, quality of life, and the medical care received related to lupus. The questionnaire consists of 43 questions within 8 HRQOL domains and 4 Non-HRQoL domains. Scores range from 0 to 100 with higher scores reflecting better quality of life.</description>
          <population>Intent to Treat</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SF-36 change from baseline at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.64" lower_limit="4.34" upper_limit="8.93"/>
                    <measurement group_id="O2" value="7.11" lower_limit="4.80" upper_limit="9.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36 change from baseline at Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.44" lower_limit="8.04" upper_limit="12.83"/>
                    <measurement group_id="O2" value="10.81" lower_limit="8.37" upper_limit="13.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LupusPRO HRQOL change from baseline at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" lower_limit="5.40" upper_limit="10.13"/>
                    <measurement group_id="O2" value="6.06" lower_limit="3.68" upper_limit="8.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LupusPRO HRQOL change from baseline at Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.24" lower_limit="6.78" upper_limit="11.70"/>
                    <measurement group_id="O2" value="9.84" lower_limit="7.33" upper_limit="12.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LupusPRO non-HRQOL change from baseline at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.06" lower_limit="-1.32" upper_limit="3.44"/>
                    <measurement group_id="O2" value="2.94" lower_limit="0.54" upper_limit="5.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LupusPRO non-HRQOL change from baseline at Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.08" lower_limit="1.60" upper_limit="6.56"/>
                    <measurement group_id="O2" value="3.74" lower_limit="1.22" upper_limit="6.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>SF-36 Change from Baseline Week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.733</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Slope</param_type>
            <param_value>-0.47</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.389</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.21</ci_lower_limit>
            <ci_upper_limit>2.26</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>SF-36 Change from Baseline at Week 52</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.801</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-0.37</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.481</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.29</ci_lower_limit>
            <ci_upper_limit>2.54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>LupusPRO HRQOL Change from Baseline at Week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.239</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>1.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.442</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.14</ci_lower_limit>
            <ci_upper_limit>4.54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>LupusPRO HRQOL Change from Baseline at Week 52</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.695</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.535</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.62</ci_lower_limit>
            <ci_upper_limit>2.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>LupusPRO non-HRQOL Change from Baseline at Week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.19</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>-1.89</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.439</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.72</ci_lower_limit>
            <ci_upper_limit>0.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>LupusPRO non-HRQOL Change from Baseline at Week 52</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.826</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Least Squares)</param_type>
            <param_value>0.826</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.531</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.67</ci_lower_limit>
            <ci_upper_limit>3.35</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Reporting period is from first dose up to 30 days following last dose (Week 52).</time_frame>
      <desc>Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose</desc>
      <group_list>
        <group group_id="E1">
          <title>Voclosporin</title>
          <description>Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
        </group>
        <group group_id="E2">
          <title>Placebo Oral Capsule</title>
          <description>Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="178"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Developmental hip dysplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="178"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Bacterial diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Lung abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Pneumonia cytomegaloviral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Diarrhoea infectious</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Herpes zoster disseminated</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Intervertebral discitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Paraspinal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Salmonellosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Salpingitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Intentional overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Systemic lupus erythematosus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cervix carcinoma stage 0</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Schwannoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Lupus encephalitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Neuropsychiatric lupus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="178"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Lupus nephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Lupus pleurisy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Abortion induced</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="161" subjects_at_risk="178"/>
                <counts group_id="E2" subjects_affected="156" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="19" subjects_affected="18" subjects_at_risk="178"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="178"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="43" subjects_affected="34" subjects_at_risk="178"/>
                <counts group_id="E2" events="23" subjects_affected="21" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="178"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="178"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="178"/>
                <counts group_id="E2" events="18" subjects_affected="17" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="178"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="178"/>
                <counts group_id="E2" events="17" subjects_affected="12" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="178"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="44" subjects_affected="31" subjects_at_risk="178"/>
                <counts group_id="E2" events="33" subjects_affected="26" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="24" subjects_affected="20" subjects_at_risk="178"/>
                <counts group_id="E2" events="20" subjects_affected="18" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="25" subjects_affected="17" subjects_at_risk="178"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="178"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="15" subjects_affected="12" subjects_at_risk="178"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="178"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" events="61" subjects_affected="43" subjects_at_risk="178"/>
                <counts group_id="E2" events="19" subjects_affected="15" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="178"/>
                <counts group_id="E2" events="20" subjects_affected="17" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="34" subjects_affected="29" subjects_at_risk="178"/>
                <counts group_id="E2" events="16" subjects_affected="11" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="14" subjects_affected="11" subjects_at_risk="178"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Lupus nephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="178"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="178"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="178"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="38" subjects_affected="35" subjects_at_risk="178"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="178"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Rashieda Gluck</name_or_title>
      <organization>Aurinia Pharmaceuticals</organization>
      <phone>1 (250) 744-2487</phone>
      <email>clinicaltrials@auriniapharma.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03021499
org study id: AUR-VCS-2016-01
nct id: NCT03021499
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the efficacy of voclosporin compared with placebo in
      achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.
The aim of the current study is to investigate whether voclosporin, added to the standard of
      care treatment in active lupus nephritis (LN), is able to reduce disease activity over a
      treatment period of 52 weeks. The background therapy will be mycophenolate mofetil (MMF) and
      initial treatment with IV methylprednisolone, followed by a reducing course of oral
      corticosteroids. Subjects with active, flaring LN will be eligible to enter the study. They
      are required to have a diagnosis of LN according to established diagnostic criteria and
      clinical and biopsy features suggestive of active nephritis. Efficacy will be assessed by the
      ability of the drug combination to reduce the level of proteinuria (as measured by Urine
      Protein Creatinine Ratio (UPCR)) while demonstrating an acceptable safety profile.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Adjudicated Renal Response at Week 52
time frame: 52 Weeks
description: The primary efficacy endpoint was the number of subjects showing renal response at Week 52. Renal response was adjudicated based on blinded data by an independent Clinical Endpoints Committee based on meeting the following criteria
UPCR of ≤0.5 mg/mg &
eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20% &
Received no rescue medication for LN &
Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during Weeks 44 through 52, prior to assessment Note:To be disqualified from renal response, the subject had to fail both eGFR measures (i.e., confirmed eGFR <60 mL/min/1.73 m2 & confirmed >20% drop from baseline) & have an associated treatment-related or disease-related AE that impacted eGFR Withdrawals prior to Week 52 with insufficient Week 52 data to determine response were defined non responders. Subjects who discontinued study drug but continued to attend study visits had their data assessed for response
measure: Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less
time frame: 52 Weeks
description: Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less
measure: Time to Urine Protein Creatinine Ratio of ≤0.5 mg/mg (Number of Days)
time frame: 52 Weeks
description: Time in days to reduction in Urine Protein Creatinine Ratio to decrease to 0.5 mg/mg or less.
measure: Number of Participants With Renal Response at Week 24
time frame: Week 24
description: Number of subjects showing renal response at Week 24. Renal response was adjudicated based on blinded data by an Independent Clinical Endpoints Committee based on the following criteria:
UPCR of ≤0.5 mg/mg, & eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%, and Received no rescue medication for LN & Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during Weeks 16 through 24, just prior to the renal response assessment. Note:To be disqualified from renal response, the subject had to fail both eGFR measures (i.e., confirmed eGFR <60 mL/min/1.73 m2 AND confirmed >20% drop from BL) & have an associated treatment-related or disease-related AE that impacted eGFR. Subjects who withdrew prior to the Week 24 assessment and provided insufficient Week 24 data to determine response were defined as non-responders. Subjects who discontinued study drug but continued to attend study visits had their data assessed for response.
measure: Number of Subjects With Partial Renal Response at Weeks 24 & 52
time frame: Weeks 24 and 52
description: Number of subjects with partial Renal Response (defined as a 50% reduction in UPCR from baseline) at Week 24 and at Week 52. Baseline UPCR is the average of 2 pre-randomisation values.
measure: Number of Subjects Achieving, and Remaining in, Renal Response (Urine Protein Creatinine Ratio ≤0.5 mg/mg)
time frame: Week 52
description: Number of subjects achieving, and remaining in, renal response (Urine Protein Creatinine ratio ≤0.5 mg/mg)
measure: Duration of Renal Response (Number of Days)
time frame: Week 52
description: Duration in days until second occurrence of UPCR >0.5 mg/mg in those subjects who achieve a reduction in UPCR to below 0.5 mg/mg
measure: Number of Subjects Achieving 50% Reduction in Urine Protein Creatinine Ratio
time frame: 52 Weeks
description: Number of subjects achieving 50% reduction in Urine Protein Creatinine ratio
measure: Time to 50% Reduction in UPCR (Number of Days)
time frame: 52 weeks
description: Time in days to reduction in Urine Protein Creatinine Ratio to decrease by 50% compared to baseline. Baseline is the average of two pre-randomisation values.
measure: Change From Baseline in eGFR
time frame: Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.
description: Change from baseline by visit in estimated Glomerular Filtration rate. eGFR is corrected to a maximum value of 90 mL/min/1.73 m2
measure: Change From Baseline in UPCR
time frame: Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.
description: Change from baseline by visit in Urine Protein Creatinine Ratio. Baseline is the average of two pre-randomisation values.
measure: Number of Subjects With Renal Response With Low Dose Steroids
time frame: Week 24 and Week 52
description: Programmed Renal Response whilst on low dose steroids (<2.5 mg/day) for the preceding 8 Weeks at Weeks 24 and 52
measure: Change From Baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA - SLEDAI)
time frame: Week 24 and Week 52
description: Change from baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score at Week 24 and 52.
The SELENA-SLEDAI tool is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-SLEDAI total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.
measure: Change From Baseline in Patient Reported Outcomes
time frame: Week 24 and Week 52
description: Health-related quality of life (HRQoL) information was collected using the Short Form Health Survey (SF-36) HRQoL assessment and the LupusPRO (v1.7) assessment.
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. Scoring ranges from 0 to 100 with higher scores reflecting better health.
LupusPro assessment is a patient-reported questionnaire regarding the effect of lupus or its treatment on the patient's health, quality of life, and the medical care received related to lupus. The questionnaire consists of 43 questions within 8 HRQOL domains and 4 Non-HRQoL domains. Scores range from 0 to 100 with higher scores reflecting better quality of life.
arm group label: Voclosporin
arm group type: Experimental
description: oral, 23.7 mg twice daily (BID)
arm group label: Placebo Oral Capsule
arm group type: Placebo Comparator
description: Voclosporin placebo, oral, 3 capsules twice daily (BID)
intervention type: Drug
intervention name: Voclosporin
description: calcineurin inhibitor
arm group label: Voclosporin
other name: ISA247
intervention type: Drug
intervention name: Placebo Oral Capsule
description: matching placebo capsule
arm group label: Placebo Oral Capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Samir Parikh, MD
role: Principal Investigator
affiliation: Ohio State University
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country: Argentina
country: Belarus
country: Brazil
country: Bulgaria
country: Canada
country: Chile
country: Colombia
country: Costa Rica
country: Croatia
country: Dominican Republic
country: Guatemala
country: Japan
country: Korea, Republic of
country: Malaysia
country: Mexico
country: Netherlands
country: North Macedonia
country: Peru
country: Philippines
country: Poland
country: Puerto Rico
country: Russian Federation
country: Serbia
country: South Africa
country: Spain
country: Taiwan
country: Thailand
country: Turkey
country: Ukraine
country: United States
country: Vietnam
country: Macedonia, The Former Yugoslav Republic of
citation: Rovin BH, Parikh SV, Hebert LA, Chan TM, Mok CC, Ginzler EM, Hooi LS, Brunetta P, Maciuca R, Solomons N. Lupus nephritis: induction therapy in severe lupus nephritis--should MMF be considered the drug of choice? Clin J Am Soc Nephrol. 2013 Jan;8(1):147-53. doi: 10.2215/CJN.03290412. Epub 2012 Aug 9.
PMID: 22879439
citation: Ling SY, Huizinga RB, Mayo PR, Larouche R, Freitag DG, Aspeslet LJ, Foster RT. Cytochrome P450 3A and P-glycoprotein drug-drug interactions with voclosporin. Br J Clin Pharmacol. 2014 Jun;77(6):1039-50. doi: 10.1111/bcp.12309.
PMID: 24330024
citation: Ling SY, Huizinga RB, Mayo PR, Freitag DG, Aspeslet LJ, Foster RT. Pharmacokinetics of voclosporin in renal impairment and hepatic impairment. J Clin Pharmacol. 2013 Dec;53(12):1303-12. doi: 10.1002/jcph.166. Epub 2013 Oct 8.
PMID: 23996158
citation: Mayo PR, Huizinga RB, Ling SY, Freitag DG, Aspeslet LJ, Foster RT. Voclosporin food effect and single oral ascending dose pharmacokinetic and pharmacodynamic studies in healthy human subjects. J Clin Pharmacol. 2013 Aug;53(8):819-26. doi: 10.1002/jcph.114. Epub 2013 Jun 4.
PMID: 23736966
citation: Dooley MA, Jayne D, Ginzler EM, Isenberg D, Olsen NJ, Wofsy D, Eitner F, Appel GB, Contreras G, Lisk L, Solomons N; ALMS Group. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. N Engl J Med. 2011 Nov 17;365(20):1886-95. doi: 10.1056/NEJMoa1014460.
PMID: 22087680
citation: Busque S, Cantarovich M, Mulgaonkar S, Gaston R, Gaber AO, Mayo PR, Ling S, Huizinga RB, Meier-Kriesche HU; PROMISE Investigators. The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation. Am J Transplant. 2011 Dec;11(12):2675-84. doi: 10.1111/j.1600-6143.2011.03763.x. Epub 2011 Sep 22.
PMID: 21943027
responsible party type: Sponsor
mesh term: Nephritis
mesh term: Lupus Nephritis
sharing ipd: No
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