<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/NCT03301467</url>
  </required_header>
  <id_info>
    <org_study_id>CL011_168</org_study_id>
    <secondary_id>1R01FD006342-01</secondary_id>
    <nct_id>NCT03301467</nct_id>
  </id_info>
  <brief_title>Controlled Trial Evaluating Avacopan in C3 Glomerulopathy</brief_title>
  <acronym>ACCOLADE</acronym>
  <official_title>A Randomized, Double Blind, Placebo Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients With C3 Glomerulopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ChemoCentryx</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medpace, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>ChemoCentryx</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 aim of this trial is to evaluate the effect of avacopan treatment on renal disease&#xD;
      activity in patients with complement component 3 glomerulopathy (C3G). Funding Source - FDA&#xD;
      OOPD&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation&#xD;
      based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit&#xD;
      disease (DDD) and C3 glomerulonephritis (C3GN). There is no approved treatment for patients&#xD;
      with C3G.&#xD;
&#xD;
      This is a randomized, double blind, placebo controlled Phase 2 study to evaluate the safety&#xD;
      and efficacy of avacopan (CCX168) in patients with C3G. Patients receive avacopan 30mg or&#xD;
      matching placebo orally twice-daily. The placebo-controlled treatment period is 26 weeks (182&#xD;
      days). This will be followed by 26 weeks during which time all patients will receive avacopan&#xD;
      (results for this second period will be reported in due course in a follow-up publication).&#xD;
      Thereafter, all patients will be followed for eight weeks (56 days) without study drug&#xD;
      treatment. The primary objective is to evaluate the efficacy of avacopan compared to placebo&#xD;
      based on histologic changes in kidney biopsies taken at baseline and after 26 weeks of&#xD;
      treatment. The primary endpoint will be based on the percent change from baseline in the C3G&#xD;
      Histologic Index for disease activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">October 27, 2021</completion_date>
  <primary_completion_date type="Actual">March 3, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Placebo crossover to active</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Matching placebo</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Subjects With Elevated C5b-9</measure>
    <time_frame>Week 26</time_frame>
    <description>Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Combined C5b-9 Strata</measure>
    <time_frame>Week 26</time_frame>
    <description>Percent change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy&#xD;
* Multiple Imputation: Missing Week 26 values are imputed using the regression method to create 100 complete datasets.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Subjects With Elevated C5b-9</measure>
    <time_frame>Week 26</time_frame>
    <description>Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Combined C5b-9 Strata</measure>
    <time_frame>Week 26</time_frame>
    <description>Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Subjects With Elevated C5b-9</measure>
    <time_frame>Week 26</time_frame>
    <description>Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Combined C5b-9 Strata</measure>
    <time_frame>Week 26</time_frame>
    <description>Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9</measure>
    <time_frame>Week 26</time_frame>
    <description>The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata</measure>
    <time_frame>Week 26</time_frame>
    <description>The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9</measure>
    <time_frame>Week 26</time_frame>
    <description>The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata</measure>
    <time_frame>Week 26</time_frame>
    <description>The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Subjects With Elevated C5b-9</measure>
    <time_frame>Week 26</time_frame>
    <description>Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (&gt;= 0.15 g/g) - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
LSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Combined C5b-9 Strata</measure>
    <time_frame>Week 26</time_frame>
    <description>Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (&gt;= 0.15 g/g) - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
LSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Subjects With Elevated C5b-9</measure>
    <time_frame>Week 26</time_frame>
    <description>Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
LSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Combined C5b-9 Strata</measure>
    <time_frame>Week 26</time_frame>
    <description>Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
LSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects With Elevated C5b-9</measure>
    <time_frame>Week 26</time_frame>
    <description>Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata</measure>
    <time_frame>Week 26</time_frame>
    <description>Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Over 26 Weeks in SF-36 v2 - Subjects With Elevated C5b-9</measure>
    <time_frame>Week 26</time_frame>
    <description>Change from baseline over 26 weeks in SF-36 v2 - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
SF-36v2: Medical Outcomes Survey Short Form-36 version 2.&#xD;
SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Over 26 Weeks in SF-36 v2 - Combined C5b-9 Strata</measure>
    <time_frame>Week 26</time_frame>
    <description>Change from baseline over 26 weeks in SF-36 v2 - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
SF-36v2: Medical Outcomes Survey Short Form-36 version 2.&#xD;
SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs</measure>
    <time_frame>From day 1 throughout the study period (day 182/week 26)</time_frame>
    <description>Number of Subjects with Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs&#xD;
AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs</measure>
    <time_frame>From day 1 throughout the study period (day 182/week 26)</time_frame>
    <description>Number of Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs&#xD;
AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>C3 Glomerulopathy (C3G)</condition>
  <arm_group>
    <arm_group_label>Avacopan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Avacopan Matching Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Avacopan</intervention_name>
    <description>Orally administered</description>
    <arm_group_label>Avacopan</arm_group_label>
    <other_name>CCX168</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Avacopan Matching Placebo</intervention_name>
    <description>avacopan matching placebo</description>
    <arm_group_label>Avacopan Matching Placebo</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Biopsy-proven C3G, either DDD or C3GN, with or without a renal transplant, and with&#xD;
             the following observations upon renal biopsy taken within 12 weeks prior to screening&#xD;
             or during screening:&#xD;
&#xD;
               1. ≥2-levels of magnitude greater staining of C3 than any combination of IgG, IgM,&#xD;
                  IgA, kappa and lambda light chains, and C1q by immunohistochemistry, and&#xD;
&#xD;
               2. evidence of proliferative glomerulonephritis (mesangial hypercellularity of&#xD;
                  greater than 3 mesangial cells per mesangial area and/or endocapillary&#xD;
                  hypercellularity defined as an increased number of cells within glomerular&#xD;
                  capillary lumina, causing luminal narrowing) based on light microscopy, and&#xD;
&#xD;
               3. confirmation of the presence of electron dense deposits in the glomeruli on&#xD;
                  electron microscopy corresponding with the C3 immunofluorescence positivity;&#xD;
&#xD;
          2. Male or female subjects, aged at least 18 years; where approved, adolescents (12-17&#xD;
             year old) may be enrolled; female subjects of childbearing potential (i.e., those who&#xD;
             have experienced menarche and who is not permanently sterile or postmenopausal,&#xD;
             defined as at least 12 consecutive months with no menses without an alternative&#xD;
             medical cause) may participate if adequate contraception is used during, and for at&#xD;
             least the three months after study completion; Male subjects with partners of&#xD;
             childbearing potential may participate in the study if they had a vasectomy at least 6&#xD;
             months prior to randomization or if adequate contraception is used during, and for at&#xD;
             least the 3 months after study completion; Adequate contraception is defined as&#xD;
             resulting in a failure rate of less than 1% per year (combined estrogen and&#xD;
             progestogen [oral, intravaginal, or transdermal], or progestogen-only hormonal&#xD;
             contraception (oral, injectable, or implantable), intra-uterine device, intra-uterine&#xD;
             hormone releasing system, bilateral tubal occlusion, vasectomized partner, or true&#xD;
             sexual abstinence, i.e., in line with the preferred and usual lifestyle of the&#xD;
             subject);&#xD;
&#xD;
          3. Willing and able to give written Informed Consent and to comply with the requirements&#xD;
             of the study protocol; written Assent and Informed Consent must be obtained from the&#xD;
             legal guardian in accordance with regional laws or regulations for subjects 12 to 17&#xD;
             years of age; and&#xD;
&#xD;
          4. Judged to be otherwise fit for the study by the Investigator, based on medical&#xD;
             history, physical examination, and clinical laboratory assessments. Subjects with&#xD;
             clinical laboratory values that are outside of normal limits (other than those&#xD;
             specified in the Exclusion Criteria) and/or with other abnormal clinical findings that&#xD;
             are judged by the Investigator not to be of clinical significance, may be entered into&#xD;
             the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or nursing;&#xD;
&#xD;
          2. Tubulointerstitial fibrosis appears to be more than 50% based on standard assessment&#xD;
             using trichrome staining of the renal biopsy;&#xD;
&#xD;
          3. Use of eculizumab or another anti-C5 antibody within 26 weeks prior to dosing;&#xD;
&#xD;
          4. Secondary C3 disease, e.g., infection-associated disease, or associated with another&#xD;
             systemic or autoimmune disease; presence of a monoclonal spike on serum or urine&#xD;
             protein electrophoresis or immunofixation assay;&#xD;
&#xD;
          5. Currently on dialysis or likely will require dialysis within 7 days after screening;&#xD;
&#xD;
          6. History or presence of any form of cancer within the 5 years prior to screening, with&#xD;
             the exception of excised basal cell or squamous cell carcinoma of the skin, or&#xD;
             carcinoma in situ such as cervical or breast carcinoma in situ that has been excised&#xD;
             or resected completely and is without evidence of local recurrence or metastasis;&#xD;
&#xD;
          7. Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency&#xD;
             virus (HIV) viral screening test indicative of acute or chronic infection;&#xD;
&#xD;
          8. Evidence of tuberculosis based on interferon γ release assay (IGRA), tuberculin&#xD;
             purified protein derivative (PPD) skin test, or chest radiography done at screening or&#xD;
             within 6 weeks prior to screening;&#xD;
&#xD;
          9. WBC count less than 3500/μL, or neutrophil count less than 1500/μL, or lymphocyte&#xD;
             count less than 500/μL before start of dosing;&#xD;
&#xD;
         10. Evidence of hepatic disease; AST, ALT, alkaline phosphatase, or bilirubin &gt;3 x the&#xD;
             upper limit of normal before start of dosing;&#xD;
&#xD;
         11. Currently using a strong inducer of the CYP3A4 enzyme, such as carbamazepine,&#xD;
             phenobarbital, phenytoin, rifampin, or St. John's wort;&#xD;
&#xD;
         12. Known hypersensitivity to avacopan or inactive ingredients of the avacopan capsules&#xD;
             (including gelatin, polyethylene glycol, or Cremophor) or inability to swallow the&#xD;
             capsules;&#xD;
&#xD;
         13. Participated in any clinical study of an investigational product within 30 days prior&#xD;
             to screening or within 5 half-lives after taking the last dose; and&#xD;
&#xD;
         14. History or presence of any medical condition or disease which, in the opinion of the&#xD;
             Investigator, may place the subject at unacceptable risk for study participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14625</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>East Providence</city>
        <state>Rhode Island</state>
        <zip>02914</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Antwerp</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Liège</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Calgary</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Aalborg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Odense</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Boulogne-sur-Mer</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Valenciennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Lübeck</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Bergamo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Parma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Leiden</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Burela De Cabo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <results_first_submitted>May 19, 2022</results_first_submitted>
  <results_first_submitted_qc>October 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 14, 2022</results_first_posted>
  <last_update_submitted>August 24, 2023</last_update_submitted>
  <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>C3 Glomerulonephritis</keyword>
  <keyword>C3 glomerulopathy</keyword>
  <keyword>C3G</keyword>
  <keyword>DDD</keyword>
  <keyword>dense deposit disease</keyword>
  <keyword>membranoproliferative glomerulonephritis</keyword>
  <keyword>MPGN</keyword>
  <keyword>C3GN</keyword>
  <keyword>idiopathic MPGN</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.</ipd_access_criteria>
    <ipd_url>http://www.amgen.com/datasharing</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</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>March 20, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03301467/Prot_000.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>November 5, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03301467/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo Group</title>
          <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
        </group>
        <group group_id="P2">
          <title>Avacopan Group</title>
          <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo Group</title>
          <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
        </group>
        <group group_id="B2">
          <title>Avacopan Group</title>
          <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</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="29"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="57"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.2" spread="17.53"/>
                    <measurement group_id="B2" value="32.2" spread="15.03"/>
                    <measurement group_id="B3" value="34.7" spread="16.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>12-17 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18-50 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>51-65 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;65 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="35"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="51"/>
                  </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>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ireland</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Denmark</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Geographic Region</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>North America</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rest of World</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age at Diagnosis of C3G</title>
          <description>C3G=C3 Glomerulopathy</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.3" spread="17.95"/>
                    <measurement group_id="B2" value="28.2" spread="17.08"/>
                    <measurement group_id="B3" value="30.8" spread="17.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>C3GN or DDD</title>
          <description>C3GN=C3 Glomerulonephritis; DDD=Dense Deposit&#xD;
Missing refers to one subject for whom disease type (C3GN vs DDD) could not be determined and subject was randomized in error.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>C3GN</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>DDD</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</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>History of Kidney Transplant</title>
          <description>Missing refers to one subject for whom disease type (C3GN vs DDD) could not be determined and subject was randomized in error.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <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>C5b-9 Stratum</title>
          <description>C5b-9 levels &lt;= 244 ng/mL were normal according to the central laboratory used for the study. Defined by assay normal range.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&gt; 244 ng/mL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;= 244 ng/mL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of C3G</title>
          <description>Calculated from the time of first diagnosis based on renal biopsy. C3G=C3 glomerulopathy</description>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.7" spread="43.78"/>
                    <measurement group_id="B2" value="48.2" spread="46.38"/>
                    <measurement group_id="B3" value="47.4" spread="44.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>eGFR</title>
          <description>eGFR=estimated Glomerular Filtration Rate</description>
          <units>mL/min/1.73m²</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.34" spread="43.509"/>
                    <measurement group_id="B2" value="79.29" spread="39.751"/>
                    <measurement group_id="B3" value="75.75" spread="41.480"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>UPCR</title>
          <description>UPCR=Urine Protein to Creatinine Ratio</description>
          <units>g/g</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.80" spread="2.435"/>
                    <measurement group_id="B2" value="4.11" spread="3.380"/>
                    <measurement group_id="B3" value="3.44" spread="2.985"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>UPCR (g/g)</title>
          <description>UPCR=Urine Protein to Creatinine Ratio&#xD;
Urine protein-to-creatinine ratio (UPCR): UPCR was calculated by dividing the level of protein in a spot urine test by the creatinine level. UPCR estimates the 24-hour protein excretion in grams per day and is used in clinical practice and clinical trials to measure the severity of proteinuria in patients.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&gt; 1 g/g</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt;= 1 g/g</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Urinary MCP-1:Creatinine Ratio</title>
          <population>2 patients missed baseline Urinary MCP-1 data.</population>
          <units>pg/mg Creatinine</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="750.29" spread="492.542"/>
                    <measurement group_id="B2" value="1215.88" spread="1303.359"/>
                    <measurement group_id="B3" value="978.85" spread="997.191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Weight</title>
          <units>kilogram(s)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.65" spread="12.631"/>
                    <measurement group_id="B2" value="78.33" spread="19.229"/>
                    <measurement group_id="B3" value="75.44" spread="16.317"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>centimeter(s)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="171.41" spread="8.773"/>
                    <measurement group_id="B2" value="173.82" spread="10.805"/>
                    <measurement group_id="B3" value="172.60" spread="9.810"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <description>BMI=Body Mass Index</description>
          <units>kilogram(s)/square meter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.65" spread="3.410"/>
                    <measurement group_id="B2" value="26.05" spread="6.375"/>
                    <measurement group_id="B3" value="25.34" spread="5.090"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>EQ-5D-5L Index Score</title>
          <description>EQ-5D-5L=EuroQuality of Life-5 Domains-5 Levels&#xD;
The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.88" spread="0.145"/>
                    <measurement group_id="B2" value="0.87" spread="0.116"/>
                    <measurement group_id="B3" value="0.88" spread="0.130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>EQ-5D-5L VAS Score</title>
          <description>EQ-5D-5L=EuroQuality of Life-5 Domains-5 Levels&#xD;
VAS=Visual Analog Scale&#xD;
The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D questionnaire includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78.83" spread="20.604"/>
                    <measurement group_id="B2" value="73.61" spread="19.070"/>
                    <measurement group_id="B3" value="76.26" spread="19.862"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Viral Test Results HIV-1/2 Antibody</title>
          <description>HIV=Human Immunodeficiency Virus</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Reactive</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>Non-reactive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Viral Test Results - Hepatitis B Virus Surface Antigen</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Reactive</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>Non-reactive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Viral Test Results - Hepatitis C Virus Antibody</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Reactive</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>
                  <title>Non-reactive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Subjects With Elevated C5b-9</title>
        <description>Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy</description>
        <time_frame>Week 26</time_frame>
        <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Subjects With Elevated C5b-9</title>
          <description>Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy</description>
          <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</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="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" lower_limit="-2.2" upper_limit="0.4"/>
                    <measurement group_id="O2" value="-1.0" lower_limit="-2.3" upper_limit="0.4"/>
                  </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>0.9670</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.9</ci_lower_limit>
            <ci_upper_limit>1.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Combined C5b-9 Strata</title>
        <description>Percent change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy&#xD;
* Multiple Imputation: Missing Week 26 values are imputed using the regression method to create 100 complete datasets.</description>
        <time_frame>Week 26</time_frame>
        <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Combined C5b-9 Strata</title>
          <description>Percent change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy&#xD;
* Multiple Imputation: Missing Week 26 values are imputed using the regression method to create 100 complete datasets.</description>
          <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
          <units>Percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.20" spread="47.302"/>
                    <measurement group_id="O2" value="-5.77" spread="5.904"/>
                  </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>0.3083</p_value>
            <method>Van Elteren's Test</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.02</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Test for normality showed that mean change and mean percent change were not normally distributed. As per SAP, Van Elteren's test was then applied to test mean percent change.&#xD;
SAP=Statistical Analysis Protocol</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Subjects With Elevated C5b-9</title>
        <description>Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy</description>
        <time_frame>Week 26</time_frame>
        <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with C3G Histological Index of Disease Activity Percent Change at Week 26 is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Subjects With Elevated C5b-9</title>
          <description>Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy</description>
          <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with C3G Histological Index of Disease Activity Percent Change at Week 26 is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</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="20"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Responder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Responder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="16"/>
                  </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>0.4591</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Cochran-Mantel-Haenszel chi square general association statistic</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Combined C5b-9 Strata</title>
        <description>Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy</description>
        <time_frame>Week 26</time_frame>
        <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with C3G Histological Index of Disease Activity Percent Change at Week 26 is reported.&#xD;
The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Combined C5b-9 Strata</title>
          <description>Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy</description>
          <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with C3G Histological Index of Disease Activity Percent Change at Week 26 is reported.&#xD;
The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</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="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Responder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Responder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="21"/>
                  </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>0.3106</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Cochran-Mantel-Haenszel chi square general association statistic</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Subjects With Elevated C5b-9</title>
        <description>Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy</description>
        <time_frame>Week 26</time_frame>
        <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Subjects With Elevated C5b-9</title>
          <description>Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy</description>
          <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</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="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="0.9" upper_limit="2.2"/>
                    <measurement group_id="O2" value="1.1" lower_limit="0.3" upper_limit="1.8"/>
                  </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>0.3368</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.5</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Combined C5b-9 Strata</title>
        <description>Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy</description>
        <time_frame>Week 26</time_frame>
        <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Combined C5b-9 Strata</title>
          <description>Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
C3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement.&#xD;
C3G=C3 glomerulopathy</description>
          <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</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="26"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="1.1" upper_limit="2.2"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0.2" upper_limit="1.4"/>
                  </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>0.0401</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.7</ci_lower_limit>
            <ci_upper_limit>-0.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9</title>
        <description>The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.</description>
        <time_frame>Week 26</time_frame>
        <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9</title>
          <description>The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.</description>
          <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
          <units>Percentage change</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="20"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.73" lower_limit="-12.29" upper_limit="2.83"/>
                    <measurement group_id="O2" value="6.11" lower_limit="-1.86" upper_limit="14.08"/>
                  </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>0.0534</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>10.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.16</ci_lower_limit>
            <ci_upper_limit>21.85</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata</title>
        <description>The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.</description>
        <time_frame>Week 26</time_frame>
        <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata</title>
          <description>The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.</description>
          <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
          <units>Percentage change</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="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.88" lower_limit="-12.32" upper_limit="0.56"/>
                    <measurement group_id="O2" value="4.79" lower_limit="-1.66" upper_limit="11.23"/>
                  </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>0.0221</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>10.67</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>19.78</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9</title>
        <description>The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.</description>
        <time_frame>Week 26</time_frame>
        <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9</title>
          <description>The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.</description>
          <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
          <units>mL/min/1.73m^2</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="20"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.57" lower_limit="-8.43" upper_limit="1.29"/>
                    <measurement group_id="O2" value="0.44" lower_limit="-4.69" upper_limit="5.56"/>
                  </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>0.2638</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.08</ci_lower_limit>
            <ci_upper_limit>11.08</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata</title>
        <description>The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.</description>
        <time_frame>Week 26</time_frame>
        <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata</title>
          <description>The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.</description>
          <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
          <units>mL/min/1.73m^2</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="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.35" lower_limit="-7.56" upper_limit="0.85"/>
                    <measurement group_id="O2" value="0.47" lower_limit="-3.75" upper_limit="4.68"/>
                  </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>0.2069</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.14</ci_lower_limit>
            <ci_upper_limit>9.77</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Subjects With Elevated C5b-9</title>
        <description>Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (&gt;= 0.15 g/g) - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
LSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio</description>
        <time_frame>Week 26</time_frame>
        <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Subjects With Elevated C5b-9</title>
          <description>Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (&gt;= 0.15 g/g) - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
LSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio</description>
          <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
          <units>Percentage change</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="20"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14" lower_limit="-34" upper_limit="12"/>
                    <measurement group_id="O2" value="-16" lower_limit="-36" upper_limit="12"/>
                  </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>0.9284</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.</method_desc>
            <param_type>LSM UPCR Ratio</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>1.45</ci_upper_limit>
            <estimate_desc>LSM UPCR Ratio Week 26 vs Baseline, Avacopan:Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Combined C5b-9 Strata</title>
        <description>Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (&gt;= 0.15 g/g) - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
LSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio</description>
        <time_frame>Week 26</time_frame>
        <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Combined C5b-9 Strata</title>
          <description>Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (&gt;= 0.15 g/g) - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
LSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio</description>
          <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
          <units>Percentage change</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="25"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14" lower_limit="-33" upper_limit="10"/>
                    <measurement group_id="O2" value="-26" lower_limit="-42" upper_limit="-6"/>
                  </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>0.3778</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.</method_desc>
            <param_type>LSM UPCR Ratio</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
            <estimate_desc>LSM UPCR Ratio Week 26 vs Baseline, Avacopan:Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Subjects With Elevated C5b-9</title>
        <description>Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
LSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1</description>
        <time_frame>Week 26</time_frame>
        <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Subjects With Elevated C5b-9</title>
          <description>Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
LSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1</description>
          <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
          <units>Percentage change</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="19"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="-18" upper_limit="25"/>
                    <measurement group_id="O2" value="-23" lower_limit="-39" upper_limit="-4"/>
                  </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>0.0810</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.</method_desc>
            <param_type>LSM MCP-1 Ratio</param_type>
            <param_value>0.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.55</ci_lower_limit>
            <ci_upper_limit>1.04</ci_upper_limit>
            <estimate_desc>LSM MCP-1 Ratio Week 26 vs Baseline, Avacopan:Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Combined C5b-9 Strata</title>
        <description>Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
LSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1</description>
        <time_frame>Week 26</time_frame>
        <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Combined C5b-9 Strata</title>
          <description>Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
LSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1</description>
          <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
          <units>Percentage change</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="24"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="-17" upper_limit="23"/>
                    <measurement group_id="O2" value="-12" lower_limit="-28" upper_limit="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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3233</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.</method_desc>
            <param_type>LSM MCP-1 Ratio</param_type>
            <param_value>0.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
            <estimate_desc>LSM MCP-1 Ratio Week 26 vs Baseline, Avacopan:Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects With Elevated C5b-9</title>
        <description>Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).</description>
        <time_frame>Week 26</time_frame>
        <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects With Elevated C5b-9</title>
          <description>Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).</description>
          <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</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="20"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EQ-5D-5L VAS Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.5" lower_limit="-7.8" upper_limit="0.8"/>
                    <measurement group_id="O2" value="-1.9" lower_limit="-6.4" upper_limit="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L Index Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0220" lower_limit="-0.0206" upper_limit="0.0647"/>
                    <measurement group_id="O2" value="-0.0202" lower_limit="-0.0653" upper_limit="0.0249"/>
                  </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>EQ-5D-5L VAS Score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6025</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.6</ci_lower_limit>
            <ci_upper_limit>7.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>EQ-5D-5L Index Score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1797</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.0422</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1043</ci_lower_limit>
            <ci_upper_limit>0.0198</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata</title>
        <description>Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).</description>
        <time_frame>Week 26</time_frame>
        <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata</title>
          <description>Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).</description>
          <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</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="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EQ-5D-5L VAS Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="-3.9" upper_limit="4.2"/>
                    <measurement group_id="O2" value="-1.9" lower_limit="-6.0" upper_limit="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-5L Index Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0060" lower_limit="-0.0334" upper_limit="0.0454"/>
                    <measurement group_id="O2" value="-0.0138" lower_limit="-0.0533" upper_limit="0.0256"/>
                  </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>EQ-5D-5L VAS Score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4898</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.9</ci_lower_limit>
            <ci_upper_limit>3.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>EQ-5D-5L Index Score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4826</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.0199</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0757</ci_lower_limit>
            <ci_upper_limit>0.0360</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Over 26 Weeks in SF-36 v2 - Subjects With Elevated C5b-9</title>
        <description>Change from baseline over 26 weeks in SF-36 v2 - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
SF-36v2: Medical Outcomes Survey Short Form-36 version 2.&#xD;
SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).</description>
        <time_frame>Week 26</time_frame>
        <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Over 26 Weeks in SF-36 v2 - Subjects With Elevated C5b-9</title>
          <description>Change from baseline over 26 weeks in SF-36 v2 - Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat Population.&#xD;
SF-36v2: Medical Outcomes Survey Short Form-36 version 2.&#xD;
SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).</description>
          <population>Subjects with Elevated C5b-9 (&gt; 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</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="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SF-36v2: Physical Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8518" lower_limit="-3.2409" upper_limit="8.9446"/>
                    <measurement group_id="O2" value="3.2197" lower_limit="-3.3108" upper_limit="9.7502"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Role-Physical</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2592" lower_limit="-11.5984" upper_limit="3.0801"/>
                    <measurement group_id="O2" value="3.5162" lower_limit="-4.2634" upper_limit="11.2958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Bodily Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="-4.2" upper_limit="11.4"/>
                    <measurement group_id="O2" value="-3.5" lower_limit="-12.0" upper_limit="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: General Health Perceptions</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" lower_limit="-7.0" upper_limit="5.2"/>
                    <measurement group_id="O2" value="1.6" lower_limit="-4.8" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Vitality</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.472" lower_limit="-8.906" upper_limit="3.963"/>
                    <measurement group_id="O2" value="3.898" lower_limit="-2.978" upper_limit="10.774"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Social Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.58" lower_limit="-2.30" upper_limit="11.47"/>
                    <measurement group_id="O2" value="0.34" lower_limit="-7.20" upper_limit="7.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Role-Emotional</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6859" lower_limit="-6.8507" upper_limit="8.2225"/>
                    <measurement group_id="O2" value="3.2461" lower_limit="-4.6899" upper_limit="11.1821"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Mental Health</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.423" lower_limit="-3.684" upper_limit="8.530"/>
                    <measurement group_id="O2" value="2.730" lower_limit="-3.791" upper_limit="9.251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Physical Component</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3257" lower_limit="-2.6090" upper_limit="1.9576"/>
                    <measurement group_id="O2" value="0.0762" lower_limit="-2.4423" upper_limit="2.5947"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Mental Component</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7556" lower_limit="-2.3560" upper_limit="3.8672"/>
                    <measurement group_id="O2" value="0.7608" lower_limit="-2.6341" upper_limit="4.1558"/>
                  </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-36v2: Physical Component Score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8161</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.4019</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.0402</ci_lower_limit>
            <ci_upper_limit>3.8440</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>SF-36v2: Mental Component Score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9982</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0052</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.5994</ci_lower_limit>
            <ci_upper_limit>4.6099</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Over 26 Weeks in SF-36 v2 - Combined C5b-9 Strata</title>
        <description>Change from baseline over 26 weeks in SF-36 v2 - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
SF-36v2: Medical Outcomes Survey Short Form-36 version 2.&#xD;
SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).</description>
        <time_frame>Week 26</time_frame>
        <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Over 26 Weeks in SF-36 v2 - Combined C5b-9 Strata</title>
          <description>Change from baseline over 26 weeks in SF-36 v2 - Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.&#xD;
SF-36v2: Medical Outcomes Survey Short Form-36 version 2.&#xD;
SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).</description>
          <population>Combined C5b-9 Strata (elevated [&gt; 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.&#xD;
ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.</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="26"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SF-36v2: Physical Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9619" lower_limit="-2.7150" upper_limit="8.6389"/>
                    <measurement group_id="O2" value="4.6532" lower_limit="-1.1123" upper_limit="10.4187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Role-Physical</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4712" lower_limit="-9.6179" upper_limit="4.6755"/>
                    <measurement group_id="O2" value="1.2077" lower_limit="-5.9734" upper_limit="8.3887"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Bodily Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="-5.7" upper_limit="8.7"/>
                    <measurement group_id="O2" value="-2.0" lower_limit="-9.3" upper_limit="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: General Health Perceptions</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" lower_limit="-6.6" upper_limit="4.6"/>
                    <measurement group_id="O2" value="0.7" lower_limit="-4.9" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Vitality</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.468" lower_limit="-6.283" upper_limit="5.348"/>
                    <measurement group_id="O2" value="4.085" lower_limit="-1.782" upper_limit="9.952"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Social Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.66" lower_limit="-1.41" upper_limit="10.73"/>
                    <measurement group_id="O2" value="1.55" lower_limit="-4.66" upper_limit="7.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Role-Emotional</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3024" lower_limit="-3.3147" upper_limit="11.9195"/>
                    <measurement group_id="O2" value="7.8375" lower_limit="0.2129" upper_limit="15.4620"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Mental Health</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.503" lower_limit="-3.911" upper_limit="6.917"/>
                    <measurement group_id="O2" value="3.914" lower_limit="-1.543" upper_limit="9.370"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Physical Component</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3578" lower_limit="-2.5452" upper_limit="1.8296"/>
                    <measurement group_id="O2" value="-0.5096" lower_limit="-2.7680" upper_limit="1.7489"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36v2: Mental Component</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3591" lower_limit="-1.7970" upper_limit="4.5153"/>
                    <measurement group_id="O2" value="2.3874" lower_limit="-0.8529" upper_limit="5.6277"/>
                  </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-36v2: Physical Component Score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9242</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.1518</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.3192</ci_lower_limit>
            <ci_upper_limit>3.0156</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>SF-36v2: Mental Component Score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6534</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.0283</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.4972</ci_lower_limit>
            <ci_upper_limit>5.5537</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs</title>
        <description>Number of Subjects with Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs&#xD;
AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment</description>
        <time_frame>From day 1 throughout the study period (day 182/week 26)</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs</title>
          <description>Number of Subjects with Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs&#xD;
AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment</description>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of subjects with at least one TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of subjects with SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of subjects with TEAEs possibly related to Study Medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of subjects with TEAEs leading to discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs</title>
        <description>Number of Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs&#xD;
AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment</description>
        <time_frame>From day 1 throughout the study period (day 182/week 26)</time_frame>
        <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Group</title>
            <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered</description>
          </group>
          <group group_id="O2">
            <title>Avacopan Group</title>
            <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs</title>
          <description>Number of Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs&#xD;
AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment</description>
          <population>Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.</population>
          <units>Adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107"/>
                    <measurement group_id="O2" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of TEAEs possibly related to Study Medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of TEAEs leading to discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From day 1 throughout the study period (day 182/week 26)</time_frame>
      <desc>An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo Group</title>
          <description>Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period&#xD;
Avacopan-matching placebo: Orally administered&#xD;
The safety population included all subjects who were randomized and had received at least one dose of study drug.</description>
        </group>
        <group group_id="E2">
          <title>Avacopan Group</title>
          <description>Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period&#xD;
Avacopan: Orally administered&#xD;
The safety population included all subjects who were randomized and had received at least one dose of study drug.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</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="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis salmonella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Bacterial parotitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Sjogren's syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcohol withdrawal syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </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="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.1</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="24" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="28"/>
              </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="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </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="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="28"/>
              </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="29"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </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>The PI shall provide Sponsor with an advance copy of any proposed publication or oral presentation at least 60 days prior to the planned date of submission or presentation and Sponsor shall have 60 days to review the proposed publication. Sponsor may request in writing, and the PI shall agree to, (a) the deletion of any Confidential Information, (b) any reasonable changes requested by Sponsor, or (c) a delay of such proposed submission for an additional period, not to exceed 90 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical trial disclosure</name_or_title>
      <organization>ChemoCentryx, Inc.</organization>
      <phone>650.210.2900</phone>
      <email>clinicaltrials@chemocentryx.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/NCT03301467
org study id: CL011_168
secondary id: 1R01FD006342-01
nct id: NCT03301467
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The aim of this trial is to evaluate the effect of avacopan treatment on renal disease
      activity in patients with complement component 3 glomerulopathy (C3G). Funding Source - FDA
      OOPD
C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation
      based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit
      disease (DDD) and C3 glomerulonephritis (C3GN). There is no approved treatment for patients
      with C3G.

      This is a randomized, double blind, placebo controlled Phase 2 study to evaluate the safety
      and efficacy of avacopan (CCX168) in patients with C3G. Patients receive avacopan 30mg or
      matching placebo orally twice-daily. The placebo-controlled treatment period is 26 weeks (182
      days). This will be followed by 26 weeks during which time all patients will receive avacopan
      (results for this second period will be reported in due course in a follow-up publication).
      Thereafter, all patients will be followed for eight weeks (56 days) without study drug
      treatment. The primary objective is to evaluate the efficacy of avacopan compared to placebo
      based on histologic changes in kidney biopsies taken at baseline and after 26 weeks of
      treatment. The primary endpoint will be based on the percent change from baseline in the C3G
      Histologic Index for disease activity.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Placebo crossover to active
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Matching placebo
measure: Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Subjects With Elevated C5b-9
time frame: Week 26
description: Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Subjects with Elevated C5b-9 (> 244 ng/mL) in the Intent-to-Treat Population.
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.
C3G=C3 glomerulopathy
measure: Percent Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Combined C5b-9 Strata
time frame: Week 26
description: Percent change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Combined C5b-9 Strata (elevated [> 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.
C3G=C3 glomerulopathy
* Multiple Imputation: Missing Week 26 values are imputed using the regression method to create 100 complete datasets.
measure: Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Subjects With Elevated C5b-9
time frame: Week 26
description: Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Subjects with Elevated C5b-9 (> 244 ng/mL) in the Intent-to-Treat Population.
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.
C3G=C3 glomerulopathy
measure: Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Combined C5b-9 Strata
time frame: Week 26
description: Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Combined C5b-9 Strata (elevated [> 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.
C3G=C3 glomerulopathy
measure: Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Subjects With Elevated C5b-9
time frame: Week 26
description: Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Subjects with Elevated C5b-9 (> 244 ng/mL) in the Intent-to-Treat Population.
C3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement.
C3G=C3 glomerulopathy
measure: Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Combined C5b-9 Strata
time frame: Week 26
description: Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Combined C5b-9 Strata (elevated [> 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.
C3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement.
C3G=C3 glomerulopathy
measure: Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9
time frame: Week 26
description: The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (> 244 ng/mL) in the Intent-to-Treat Population.
measure: Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata
time frame: Week 26
description: The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated [> 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.
measure: Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9
time frame: Week 26
description: The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (> 244 ng/mL) in the Intent-to-Treat Population.
measure: Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata
time frame: Week 26
description: The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated [> 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.
measure: Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Subjects With Elevated C5b-9
time frame: Week 26
description: Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (>= 0.15 g/g) - Subjects with Elevated C5b-9 (> 244 ng/mL) in the Intent-to-Treat Population.
LSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio
measure: Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Combined C5b-9 Strata
time frame: Week 26
description: Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (>= 0.15 g/g) - Combined C5b-9 Strata (elevated [> 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.
LSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio
measure: Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Subjects With Elevated C5b-9
time frame: Week 26
description: Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Subjects with Elevated C5b-9 (> 244 ng/mL) in the Intent-to-Treat Population.
LSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1
measure: Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Combined C5b-9 Strata
time frame: Week 26
description: Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Combined C5b-9 Strata (elevated [> 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.
LSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1
measure: Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects With Elevated C5b-9
time frame: Week 26
description: Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects with Elevated C5b-9 (> 244 ng/mL) in the Intent-to-Treat Population.
EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).
measure: Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata
time frame: Week 26
description: Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata (elevated [> 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.
EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).
measure: Change From Baseline Over 26 Weeks in SF-36 v2 - Subjects With Elevated C5b-9
time frame: Week 26
description: Change from baseline over 26 weeks in SF-36 v2 - Subjects with Elevated C5b-9 (> 244 ng/mL) in the Intent-to-Treat Population.
SF-36v2: Medical Outcomes Survey Short Form-36 version 2.
SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).
measure: Change From Baseline Over 26 Weeks in SF-36 v2 - Combined C5b-9 Strata
time frame: Week 26
description: Change from baseline over 26 weeks in SF-36 v2 - Combined C5b-9 Strata (elevated [> 244 ng/mL] and non-elevated C5b-9) in the Intent-to-Treat Population.
SF-36v2: Medical Outcomes Survey Short Form-36 version 2.
SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).
measure: Number of Subjects With Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs
time frame: From day 1 throughout the study period (day 182/week 26)
description: Number of Subjects with Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs
AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment
measure: Number of Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs
time frame: From day 1 throughout the study period (day 182/week 26)
description: Number of Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs
AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment
arm group label: Avacopan
arm group type: Experimental
description: Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
arm group label: Avacopan Matching Placebo
arm group type: Placebo Comparator
description: Matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
intervention type: Drug
intervention name: Avacopan
description: Orally administered
arm group label: Avacopan
other name: CCX168
intervention type: Drug
intervention name: Avacopan Matching Placebo
description: avacopan matching placebo
arm group label: Avacopan Matching Placebo
other name: placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Canada
country: Denmark
country: France
country: Germany
country: Ireland
country: Italy
country: Netherlands
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
ipd access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
ipd url: http://www.amgen.com/datasharing
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 