<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/NCT03832114</url>
  </required_header>
  <id_info>
    <org_study_id>CLNP023X2202</org_study_id>
    <nct_id>NCT03832114</nct_id>
  </id_info>
  <brief_title>Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted</brief_title>
  <official_title>An Open-label, Non-randomized Study on Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of LNP023 in Two Patient Populations With C3 Glomerulopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</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 study is an open-label, two cohort non-randomized study evaluating the efficacy, safety,&#xD;
      and pharmacokinetics of LNP023 in patients with C3G (Cohort A) and patients who have&#xD;
      undergone kidney transplant and have C3G recurrence (Cohort B).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Actual">April 23, 2021</completion_date>
  <primary_completion_date type="Actual">April 23, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The study is an open-label, two cohort non-randomized study evaluating the efficacy, safety, and pharmacokinetics of LNP023 in patients with C3G (Cohort A) and patients who have undergone kidney transplant and have C3G recurrence (Cohort B).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open label study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cohort A: Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR)</measure>
    <time_frame>Week 12</time_frame>
    <description>Change in proteinuria assessed by ratio to baseline of UPCR derived from 24h urine collection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cohort B: Change From Baseline in C3 Deposit</measure>
    <time_frame>Week 12</time_frame>
    <description>Histopathological changes in kidney biopsies as assessed by change from baseline in C3 Deposit Score (based on immunofluorescence microscopy)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Urine Protein Creatinine Concentration Ratio (UPCR)</measure>
    <time_frame>Week 12: Day 84</time_frame>
    <description>Ratio to baseline UPCR derived from 24 hour urine collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Urine Protein (UP) Excretion</measure>
    <time_frame>Week 12: Day 84</time_frame>
    <description>Ratio to baseline UP excretion derived from 24 hour urine collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Urine Albumin Creatinine Concentration Ratio (UACR) Excretion</measure>
    <time_frame>Week 12: Day 84</time_frame>
    <description>Ratio to baseline UACR excretion derived from 24 hour urine collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Change in Urinary Albumin (UA) Excretion</measure>
    <time_frame>Week 12: Day 84</time_frame>
    <description>Ratio to baseline UA excretion derived from 24 hour urine collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)</measure>
    <time_frame>Day 84</time_frame>
    <description>Effect of LNP023 on estimated glomerular filtration rate (eGFR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Creatinine</measure>
    <time_frame>Week 12: Day 84</time_frame>
    <description>The effect of LNP023 on renal function - serum creatinine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Creatinine Clearance</measure>
    <time_frame>Week 12: Day 84</time_frame>
    <description>The effect of LNP023 on renal function - creatinine clearance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Hematuria</measure>
    <time_frame>Week 12: Day 84</time_frame>
    <description>The effect of LNP023 on renal function - hematuria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR) First Morning Void</measure>
    <time_frame>Week 9: Day 64</time_frame>
    <description>Ratio to baseline of UPCR reduction derived from total cumulative urinary excretion first morning void</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Urine Albumin to Creatinine Concentration Ratio (UACR) First Morning Void</measure>
    <time_frame>Week 9: Day 64</time_frame>
    <description>UACR reduction derived from total cumulative urinary excretion first morning void</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of LNP023 Area Under the Plasma-concentration-time Curve AUClast (AUC)</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
    <description>Plasma: Non-compartmental parameter analysis related to total drug for the area under the plasma-concentration-time curve calculated from time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of LNP023 Area Under the Plasma-concentration-time Curve AUCtau (AUC)</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
    <description>Plasma: Non-compartmental parameter analysis related to total drug for the area under the plasma-concentration-time curve calculated to the end of the dosing interval (ngxh/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Maximum Concentration After Drug Administration (Cmax)</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
    <description>Plasma: Non-compartmental parameter analysis related to total drug, including but not limited to Cmax after the first dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Mimum Concentration After Drug Administration (Ctrough)</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
    <description>Plasma: Non-compartmental parameter analysis related to total drug, including but not limited to Ctrough (Cmin) after the first dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach the Maximum Plasma Concentration (Tmax)</measure>
    <time_frame>Weeks 1, 2, 3, 4</time_frame>
    <description>Plasma: Non-compartmental parameter analysis related to total drug, including but not limited to Tmax after the first dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summary of Change From Baseline Complement C3 Biomarker in Serum</measure>
    <time_frame>Weeks 1, 2, 3, 4, 12</time_frame>
    <description>To assess the effect of LNP023 on alternative complement pathway hyperactivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio to Baseline Summary of Plasma Bb in Blood and Urine</measure>
    <time_frame>Week 1, 2, 3, 4 and 12</time_frame>
    <description>To assess the relationship between LNP023 dose and pharmacodynamic biomarker levels of blood Bb in blood and urine</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Glomerulonephritis</condition>
  <arm_group>
    <arm_group_label>Cohort A - no kidney transplant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>C3G patients who have not received a kidney transplant and have reduced C3 blood levels.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B - kidney transplant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>C3G patients who have received a kidney transplant and have C3G recurrence.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LNP023</intervention_name>
    <description>Increasing doses of LNP023 up to 200 mg.</description>
    <arm_group_label>Cohort A - no kidney transplant</arm_group_label>
    <arm_group_label>Cohort B - kidney transplant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for Cohort A and B:&#xD;
&#xD;
          -  Written informed consent must be obtained before any assessment is performed&#xD;
&#xD;
          -  Male and female patients between the ages of 18 to 65 (inclusive) at screening&#xD;
&#xD;
          -  C3G patients wit proteinuria&#xD;
&#xD;
          -  Able to communicate well with the investigator, to understand and comply with the&#xD;
             requirements of the study&#xD;
&#xD;
          -  At screening and baseline visits, patients must weigh at least 35 kg&#xD;
&#xD;
          -  Supine vital signs should be within the following ranges :&#xD;
&#xD;
        oral body temperature between 35.0-37.5 °C systolic blood pressure, 80-170 mm Hg diastolic&#xD;
        blood pressure, 50-105 mm Hg pulse rate, 45 - 100 bpm&#xD;
&#xD;
        .&#xD;
&#xD;
        Inclusion Criteria for Cohort A:&#xD;
&#xD;
          -  Estimated GFR (using the CKD-EPI formula) or measured GFR ≥30 mL/min per 1.73 m2 for&#xD;
             patients on a maximum recommended or maximum tolerated dose of an angiotensin&#xD;
             converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)&#xD;
&#xD;
          -  UPCR ≥ 100 mg/mmol (equivalent to ≥ 1 g/24h total urinary protein excretion)&#xD;
&#xD;
          -  Prior to entry, all patients must have been on supportive care including a maximally&#xD;
             tolerated dose of ACEi or ARB for at least 30 days.&#xD;
&#xD;
        Inclusion Criteria for Cohort B:&#xD;
&#xD;
          -  No histological/laboratory/clinical signs of allorejection&#xD;
&#xD;
          -  If applicable, induction treatment after allotransplantation needs to be completed &gt;30&#xD;
             days before inclusion.&#xD;
&#xD;
          -  Transplantation of a kidney allograft &gt;90 days before inclusion&#xD;
&#xD;
          -  Patients need to be on a stable dose of immunsuppressive regimen prior to inclusion.&#xD;
             Any approved treatments are allowed for this purpose.&#xD;
&#xD;
        Exclusion Criteria for Cohort A and B:&#xD;
&#xD;
          -  Use of other investigational drugs at the time of enrollment, or within 5 half-lives&#xD;
             of randomization, or within 30 days, whichever is longer; or longer if required by&#xD;
             local regulations&#xD;
&#xD;
          -  A history of clinically significant ECG abnormalities,&#xD;
&#xD;
          -  Known family history or known presence of long QT syndrome or Torsades de Pointes&#xD;
&#xD;
          -  Use of agents known to prolong the QT interval unless they can be permanently&#xD;
             discontinued for the duration of the study&#xD;
&#xD;
          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a&#xD;
             female after conception and until the termination of gestation, confirmed by a&#xD;
             positive hCG laboratory test.&#xD;
&#xD;
          -  Women of child bearing potential, defined as all women physiologically capable of&#xD;
             becoming pregnant, unless they are using highly effective methods of contraception&#xD;
             during dosing and for 1 week after stopping of investigational drug.&#xD;
&#xD;
          -  History of immunodeficiency diseases, or a positive HIV test result.&#xD;
&#xD;
          -  Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV).&#xD;
&#xD;
          -  Patients who cannot receive vaccinations against N. meningitidis, S. pneumoniae, or H.&#xD;
             influenzae&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ranica</city>
        <state>BG</state>
        <zip>24020</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <state>Catalunya</state>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>London</city>
        <zip>W12 0NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1070</url>
    <description>link to plain language trial summary</description>
  </link>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <results_first_submitted>April 22, 2022</results_first_submitted>
  <results_first_submitted_qc>June 13, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 8, 2022</results_first_posted>
  <last_update_submitted>August 8, 2022</last_update_submitted>
  <last_update_submitted_qc>August 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glomerulonephritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
  </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>February 7, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03832114/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>December 2, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03832114/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 27 patients (16 patients in Cohort A and 11 patients in Cohort B) were enrolled and treated in the treatment period 1. All 27 patients completed the study and there were no patients who discontinued the study.</recruitment_details>
      <pre_assignment_details>A total of 27 patients (16 patients in Cohort A and 11 patients in Cohort B) were enrolled and treated in the treatment period 1. All 27 patients completed the study and there were no patients who discontinued the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort A: Run-In Phase</title>
          <description>Cohort A: No kidney transplant. C3G patients who have not received a kidney transplant and have reduced C3 blood levels</description>
        </group>
        <group group_id="P2">
          <title>Cohort B: Run-In Phase</title>
          <description>Cohort B: kidney transplant. C3G patients who have received a kidney transplant and have C3G recurrence</description>
        </group>
        <group group_id="P3">
          <title>Cohort A: Dose Escalation/LNP023 Treatment 200 mg b.i.d</title>
          <description>Cohort A - no kidney transplant C3G patients who have not received a kidney transplant and have reduced C3 blood levels</description>
        </group>
        <group group_id="P4">
          <title>Cohort B - Dose Escalation/LNP023 Treatment 200 mg b.i.d</title>
          <description>Cohort B - kidney transplant C3G patients who have received a kidney transplant and have C3G recurrence</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Run-in Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Dose Escalation/200mg b.i.d Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>For all analysis sets, patients were analyzed according to study drug received for Cohort A and B. Safety analysis set included all patients that received any study drug. PK analysis set included all patients with available PK data and no protocol deviations with relevant impact on PK data.</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort A - no Kidney Transplant</title>
          <description>C3G patients who have not received a kidney transplant and have reduced C3 blood levels.</description>
        </group>
        <group group_id="B2">
          <title>Cohort B - Kidney Transplant</title>
          <description>C3G patients who have received a kidney transplant and have C3G recurrence.</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="16"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="27"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <description>Age in Years</description>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.0" lower_limit="18" upper_limit="59"/>
                    <measurement group_id="B2" value="31.0" lower_limit="18" upper_limit="70"/>
                    <measurement group_id="B3" value="24.0" lower_limit="18" upper_limit="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian or Alaska</title>
              <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>
              <title>Black or African American</title>
              <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>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino</title>
              <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>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cohort A: Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR)</title>
        <description>Change in proteinuria assessed by ratio to baseline of UPCR derived from 24h urine collection</description>
        <time_frame>Week 12</time_frame>
        <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A - no Kidney Transplant</title>
            <description>C3G patients who have not received a kidney transplant and have reduced C3 blood levels.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort A: Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR)</title>
          <description>Change in proteinuria assessed by ratio to baseline of UPCR derived from 24h urine collection</description>
          <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.55" lower_limit="0.46" upper_limit="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Log Ratio to Baseline</non_inferiority_desc>
            <p_value>0.0003</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.55</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>0.65</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cohort B: Change From Baseline in C3 Deposit</title>
        <description>Histopathological changes in kidney biopsies as assessed by change from baseline in C3 Deposit Score (based on immunofluorescence microscopy)</description>
        <time_frame>Week 12</time_frame>
        <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort B - Kidney Transplant</title>
            <description>C3G patients who have received a kidney transplant and have C3G recurrence.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort B: Change From Baseline in C3 Deposit</title>
          <description>Histopathological changes in kidney biopsies as assessed by change from baseline in C3 Deposit Score (based on immunofluorescence microscopy)</description>
          <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
          <units>Percentage change</units>
          <param>Median</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.50" lower_limit="-3.75" upper_limit="-0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0313</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-2.50</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.75</ci_lower_limit>
            <ci_upper_limit>-0.75</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Urine Protein Creatinine Concentration Ratio (UPCR)</title>
        <description>Ratio to baseline UPCR derived from 24 hour urine collection</description>
        <time_frame>Week 12: Day 84</time_frame>
        <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A - no Kidney Transplant</title>
            <description>C3G patients who have not received a kidney transplant and have reduced C3 blood levels.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B - Kidney Transplant</title>
            <description>C3G patients who have received a kidney transplant and have C3G recurrence.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Urine Protein Creatinine Concentration Ratio (UPCR)</title>
          <description>Ratio to baseline UPCR derived from 24 hour urine collection</description>
          <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.55" lower_limit="0.46" upper_limit="0.65"/>
                    <measurement group_id="O2" value="0.79" lower_limit="0.49" upper_limit="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.55</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>0.65</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.4766</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.79</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>1.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Overall- Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>Mixed Model of Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.59</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.51</ci_lower_limit>
            <ci_upper_limit>0.69</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Urine Protein (UP) Excretion</title>
        <description>Ratio to baseline UP excretion derived from 24 hour urine collection</description>
        <time_frame>Week 12: Day 84</time_frame>
        <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A - no Kidney Transplant</title>
            <description>C3G patients who have not received a kidney transplant and have reduced C3 blood levels.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B - Kidney Transplant</title>
            <description>C3G patients who have received a kidney transplant and have C3G recurrence.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Urine Protein (UP) Excretion</title>
          <description>Ratio to baseline UP excretion derived from 24 hour urine collection</description>
          <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.57" lower_limit="0.47" upper_limit="0.68"/>
                    <measurement group_id="O2" value="1.00" lower_limit="0.75" upper_limit="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0011</p_value>
            <method>Mixed Model Repeated Measures (MMRM</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.57</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.47</ci_lower_limit>
            <ci_upper_limit>0.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9998</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Overall- Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0016</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.66</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.56</ci_lower_limit>
            <ci_upper_limit>0.77</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Urine Albumin Creatinine Concentration Ratio (UACR) Excretion</title>
        <description>Ratio to baseline UACR excretion derived from 24 hour urine collection</description>
        <time_frame>Week 12: Day 84</time_frame>
        <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A - no Kidney Transplant</title>
            <description>C3G patients who have not received a kidney transplant and have reduced C3 blood levels.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B - Kidney Transplant</title>
            <description>C3G patients who have received a kidney transplant and have C3G recurrence.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Urine Albumin Creatinine Concentration Ratio (UACR) Excretion</title>
          <description>Ratio to baseline UACR excretion derived from 24 hour urine collection</description>
          <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.55" lower_limit="0.47" upper_limit="0.64"/>
                    <measurement group_id="O2" value="0.61" lower_limit="0.30" upper_limit="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Model Repeated Measures (MRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.55</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.47</ci_lower_limit>
            <ci_upper_limit>0.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.3707</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.61</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.30</ci_lower_limit>
            <ci_upper_limit>1.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Overall- Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.60</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.51</ci_lower_limit>
            <ci_upper_limit>0.71</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Change in Urinary Albumin (UA) Excretion</title>
        <description>Ratio to baseline UA excretion derived from 24 hour urine collection</description>
        <time_frame>Week 12: Day 84</time_frame>
        <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A - no Kidney Transplant</title>
            <description>C3G patients who have not received a kidney transplant and have reduced C3 blood levels.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B - Kidney Transplant</title>
            <description>C3G patients who have received a kidney transplant and have C3G recurrence.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Change in Urinary Albumin (UA) Excretion</title>
          <description>Ratio to baseline UA excretion derived from 24 hour urine collection</description>
          <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.57" lower_limit="0.47" upper_limit="0.70"/>
                    <measurement group_id="O2" value="0.81" lower_limit="0.67" upper_limit="0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0018</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.57</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.47</ci_lower_limit>
            <ci_upper_limit>0.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1632</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.81</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>0.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Overall- Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0040</p_value>
            <method>Mixed Model Repeated Measure (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.67</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.57</ci_lower_limit>
            <ci_upper_limit>0.79</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)</title>
        <description>Effect of LNP023 on estimated glomerular filtration rate (eGFR)</description>
        <time_frame>Day 84</time_frame>
        <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A - no Kidney Transplant</title>
            <description>C3G patients who have not received a kidney transplant and have reduced C3 blood levels.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B - Kidney Transplant</title>
            <description>C3G patients who have received a kidney transplant and have C3G recurrence.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)</title>
          <description>Effect of LNP023 on estimated glomerular filtration rate (eGFR)</description>
          <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
          <units>ml/min</units>
          <param>Mean</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.59" lower_limit="0.12" upper_limit="5.06"/>
                    <measurement group_id="O2" value="-0.61" lower_limit="-3.36" upper_limit="2.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1795</p_value>
            <method>Mixed Model of Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.59</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.12</ci_lower_limit>
            <ci_upper_limit>5.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.7763</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.61</param_value>
            <ci_percent>0.7763</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.36</ci_lower_limit>
            <ci_upper_limit>2.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Overall- Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.3754</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.32</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.59</ci_lower_limit>
            <ci_upper_limit>3.22</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Creatinine</title>
        <description>The effect of LNP023 on renal function - serum creatinine</description>
        <time_frame>Week 12: Day 84</time_frame>
        <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A - no Kidney Transplant</title>
            <description>C3G patients who have not received a kidney transplant and have reduced C3 blood levels.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B - Kidney Transplant</title>
            <description>C3G patients who have received a kidney transplant and have C3G recurrence.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Creatinine</title>
          <description>The effect of LNP023 on renal function - serum creatinine</description>
          <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.04" lower_limit="-9.36" upper_limit="-0.72"/>
                    <measurement group_id="O2" value="7.17" lower_limit="-1.79" upper_limit="16.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1364</p_value>
            <method>Mixed Model Repeated Measuers (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-5.04</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.36</ci_lower_limit>
            <ci_upper_limit>-0.72</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.3038</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.17</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.79</ci_lower_limit>
            <ci_upper_limit>16.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Overall- Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8352</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.77</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.56</ci_lower_limit>
            <ci_upper_limit>4.01</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Creatinine Clearance</title>
        <description>The effect of LNP023 on renal function - creatinine clearance</description>
        <time_frame>Week 12: Day 84</time_frame>
        <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A - no Kidney Transplant</title>
            <description>C3G patients who have not received a kidney transplant and have reduced C3 blood levels.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B - Kidney Transplant</title>
            <description>C3G patients who have received a kidney transplant and have C3G recurrence.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Creatinine Clearance</title>
          <description>The effect of LNP023 on renal function - creatinine clearance</description>
          <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
          <units>mL/min</units>
          <param>Geometric Mean</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.07" lower_limit="0.99" upper_limit="1.17"/>
                    <measurement group_id="O2" value="1.20" lower_limit="0.83" upper_limit="1.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2752</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.07</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.99</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.476</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.20</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>1.72</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Overall- Day 84</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1963</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.10</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.00</ci_lower_limit>
            <ci_upper_limit>1.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Hematuria</title>
        <description>The effect of LNP023 on renal function - hematuria</description>
        <time_frame>Week 12: Day 84</time_frame>
        <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable. n: number of patients in the respective baseline category and post-baseline time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A - no Kidney Transplant</title>
            <description>C3G patients who have not received a kidney transplant and have reduced C3 blood levels.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B - Kidney Transplant</title>
            <description>C3G patients who have received a kidney transplant and have C3G recurrence.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Hematuria</title>
          <description>The effect of LNP023 on renal function - hematuria</description>
          <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable. n: number of patients in the respective baseline category and post-baseline time point.</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="16"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12: Day 84: &lt;9 rbc/hpf n (%)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: Day 84: &gt;= 9 to =&lt;50 rbc/hpf n (%)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: Day 84: &gt;50 rbc/hpf n (%)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR) First Morning Void</title>
        <description>Ratio to baseline of UPCR reduction derived from total cumulative urinary excretion first morning void</description>
        <time_frame>Week 9: Day 64</time_frame>
        <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A - no Kidney Transplant</title>
            <description>C3G patients who have not received a kidney transplant and have reduced C3 blood levels.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B - Kidney Transplant</title>
            <description>C3G patients who have received a kidney transplant and have C3G recurrence.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR) First Morning Void</title>
          <description>Ratio to baseline of UPCR reduction derived from total cumulative urinary excretion first morning void</description>
          <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.56" lower_limit="0.48" upper_limit="0.65"/>
                    <measurement group_id="O2" value="0.99" lower_limit="0.76" upper_limit="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Day 64</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.56</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.48</ci_lower_limit>
            <ci_upper_limit>0.65</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 64</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9544</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>1.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Overall- Day 64</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.64</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.56</ci_lower_limit>
            <ci_upper_limit>0.72</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Urine Albumin to Creatinine Concentration Ratio (UACR) First Morning Void</title>
        <description>UACR reduction derived from total cumulative urinary excretion first morning void</description>
        <time_frame>Week 9: Day 64</time_frame>
        <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A - no Kidney Transplant</title>
            <description>C3G patients who have not received a kidney transplant and have reduced C3 blood levels.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B - Kidney Transplant</title>
            <description>C3G patients who have received a kidney transplant and have C3G recurrence.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Urine Albumin to Creatinine Concentration Ratio (UACR) First Morning Void</title>
          <description>UACR reduction derived from total cumulative urinary excretion first morning void</description>
          <population>Pharmacodynamics (PD) Analysis Set 1: number of patients included in the analysis with at least one post-baseline value of the outcome variable</population>
          <units>g/mol</units>
          <param>Geometric Mean</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.59" lower_limit="0.50" upper_limit="0.69"/>
                    <measurement group_id="O2" value="0.87" lower_limit="0.60" upper_limit="1.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Day 64</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.59</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>0.69</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 64</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.6209</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0.87</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>1.26</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Overall- Day 64</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.63</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.54</ci_lower_limit>
            <ci_upper_limit>0.73</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of LNP023 Area Under the Plasma-concentration-time Curve AUClast (AUC)</title>
        <description>Plasma: Non-compartmental parameter analysis related to total drug for the area under the plasma-concentration-time curve calculated from time</description>
        <time_frame>Weeks 1, 2, 3, 4</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics of LNP023 Area Under the Plasma-concentration-time Curve AUCtau (AUC)</title>
        <description>Plasma: Non-compartmental parameter analysis related to total drug for the area under the plasma-concentration-time curve calculated to the end of the dosing interval (ngxh/mL)</description>
        <time_frame>Weeks 1, 2, 3, 4</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Observed Maximum Concentration After Drug Administration (Cmax)</title>
        <description>Plasma: Non-compartmental parameter analysis related to total drug, including but not limited to Cmax after the first dose.</description>
        <time_frame>Weeks 1, 2, 3, 4</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Observed Mimum Concentration After Drug Administration (Ctrough)</title>
        <description>Plasma: Non-compartmental parameter analysis related to total drug, including but not limited to Ctrough (Cmin) after the first dose.</description>
        <time_frame>Weeks 1, 2, 3, 4</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach the Maximum Plasma Concentration (Tmax)</title>
        <description>Plasma: Non-compartmental parameter analysis related to total drug, including but not limited to Tmax after the first dose.</description>
        <time_frame>Weeks 1, 2, 3, 4</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Summary of Change From Baseline Complement C3 Biomarker in Serum</title>
        <description>To assess the effect of LNP023 on alternative complement pathway hyperactivity</description>
        <time_frame>Weeks 1, 2, 3, 4, 12</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ratio to Baseline Summary of Plasma Bb in Blood and Urine</title>
        <description>To assess the relationship between LNP023 dose and pharmacodynamic biomarker levels of blood Bb in blood and urine</description>
        <time_frame>Week 1, 2, 3, 4 and 12</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 2 months.</time_frame>
      <desc>Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort A - Run-in Phase</title>
          <description>No Kidney Transplant- C3G patients who have not received a kidney transplant and have reduced C3 blood levels</description>
        </group>
        <group group_id="E2">
          <title>Cohort A - Dose Escalation Phase</title>
          <description>No Kidney Transplant- C3G patients who have not received a kidney transplant and have reduced C3 blood levels</description>
        </group>
        <group group_id="E3">
          <title>Cohort A - LNP023 200mg b.i.d</title>
          <description>No Kidney Transplant- C3G patients who have not received a kidney transplant and have reduced C3 blood levels</description>
        </group>
        <group group_id="E4">
          <title>Cohort B - Run-in Phase</title>
          <description>Kidney Transplant- C3G patients who have received a kidney transplant and have C3G recurrence</description>
        </group>
        <group group_id="E5">
          <title>Cohort B - Dose Escalation Phase</title>
          <description>Kidney Transplant- C3G patients who have received a kidney transplant and have C3G recurrence</description>
        </group>
        <group group_id="E6">
          <title>Cohort B - LNP023 200mg b.i.d</title>
          <description>Kidney Transplant- C3G patients who have received a kidney transplant and have C3G recurrence</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (24.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (24.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Normochromic normocytic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood luteinising hormone increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Anosmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Adjustment disorder with depressed mood</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Intentional self-injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Spider vein</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
              </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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Novartis Pharmaceuticals</organization>
      <phone>862-778-8300</phone>
      <email>Novartis.email@novartis.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/NCT03832114
org study id: CLNP023X2202
nct id: NCT03832114
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The study is an open-label, two cohort non-randomized study evaluating the efficacy, safety,
      and pharmacokinetics of LNP023 in patients with C3G (Cohort A) and patients who have
      undergone kidney transplant and have C3G recurrence (Cohort B).
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: The study is an open-label, two cohort non-randomized study evaluating the efficacy, safety, and pharmacokinetics of LNP023 in patients with C3G (Cohort A) and patients who have undergone kidney transplant and have C3G recurrence (Cohort B).
primary purpose: Treatment
masking: None (Open Label)
masking description: Open label study
measure: Cohort A: Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR)
time frame: Week 12
description: Change in proteinuria assessed by ratio to baseline of UPCR derived from 24h urine collection
measure: Cohort B: Change From Baseline in C3 Deposit
time frame: Week 12
description: Histopathological changes in kidney biopsies as assessed by change from baseline in C3 Deposit Score (based on immunofluorescence microscopy)
measure: Change From Baseline in Urine Protein Creatinine Concentration Ratio (UPCR)
time frame: Week 12: Day 84
description: Ratio to baseline UPCR derived from 24 hour urine collection
measure: Change From Baseline in Urine Protein (UP) Excretion
time frame: Week 12: Day 84
description: Ratio to baseline UP excretion derived from 24 hour urine collection
measure: Change From Baseline in Urine Albumin Creatinine Concentration Ratio (UACR) Excretion
time frame: Week 12: Day 84
description: Ratio to baseline UACR excretion derived from 24 hour urine collection
measure: Change From Baseline Change in Urinary Albumin (UA) Excretion
time frame: Week 12: Day 84
description: Ratio to baseline UA excretion derived from 24 hour urine collection
measure: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
time frame: Day 84
description: Effect of LNP023 on estimated glomerular filtration rate (eGFR)
measure: Change From Baseline in Serum Creatinine
time frame: Week 12: Day 84
description: The effect of LNP023 on renal function - serum creatinine
measure: Change From Baseline in Creatinine Clearance
time frame: Week 12: Day 84
description: The effect of LNP023 on renal function - creatinine clearance
measure: Number of Patients With Hematuria
time frame: Week 12: Day 84
description: The effect of LNP023 on renal function - hematuria
measure: Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR) First Morning Void
time frame: Week 9: Day 64
description: Ratio to baseline of UPCR reduction derived from total cumulative urinary excretion first morning void
measure: Change From Baseline in Urine Albumin to Creatinine Concentration Ratio (UACR) First Morning Void
time frame: Week 9: Day 64
description: UACR reduction derived from total cumulative urinary excretion first morning void
measure: Pharmacokinetics of LNP023 Area Under the Plasma-concentration-time Curve AUClast (AUC)
time frame: Weeks 1, 2, 3, 4
description: Plasma: Non-compartmental parameter analysis related to total drug for the area under the plasma-concentration-time curve calculated from time
measure: Pharmacokinetics of LNP023 Area Under the Plasma-concentration-time Curve AUCtau (AUC)
time frame: Weeks 1, 2, 3, 4
description: Plasma: Non-compartmental parameter analysis related to total drug for the area under the plasma-concentration-time curve calculated to the end of the dosing interval (ngxh/mL)
measure: Observed Maximum Concentration After Drug Administration (Cmax)
time frame: Weeks 1, 2, 3, 4
description: Plasma: Non-compartmental parameter analysis related to total drug, including but not limited to Cmax after the first dose.
measure: Observed Mimum Concentration After Drug Administration (Ctrough)
time frame: Weeks 1, 2, 3, 4
description: Plasma: Non-compartmental parameter analysis related to total drug, including but not limited to Ctrough (Cmin) after the first dose.
measure: Time to Reach the Maximum Plasma Concentration (Tmax)
time frame: Weeks 1, 2, 3, 4
description: Plasma: Non-compartmental parameter analysis related to total drug, including but not limited to Tmax after the first dose.
measure: Summary of Change From Baseline Complement C3 Biomarker in Serum
time frame: Weeks 1, 2, 3, 4, 12
description: To assess the effect of LNP023 on alternative complement pathway hyperactivity
measure: Ratio to Baseline Summary of Plasma Bb in Blood and Urine
time frame: Week 1, 2, 3, 4 and 12
description: To assess the relationship between LNP023 dose and pharmacodynamic biomarker levels of blood Bb in blood and urine
arm group label: Cohort A - no kidney transplant
arm group type: Experimental
description: C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
arm group label: Cohort B - kidney transplant
arm group type: Experimental
description: C3G patients who have received a kidney transplant and have C3G recurrence.
intervention type: Drug
intervention name: LNP023
description: Increasing doses of LNP023 up to 200 mg.
arm group label: Cohort A - no kidney transplant
arm group label: Cohort B - kidney transplant
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Germany
country: Italy
country: Spain
country: United Kingdom
country: United States
url: https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1070
description: link to plain language trial summary
responsible party type: Sponsor
mesh term: Glomerulonephritis
sharing ipd: Yes
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 