<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/NCT04408820</url>
  </required_header>
  <id_info>
    <org_study_id>1517-MA-3318</org_study_id>
    <nct_id>NCT04408820</nct_id>
  </id_info>
  <brief_title>Post-marketing Surveillance of EVRENZO® Tablets (Roxadustat) in Patients With Renal Anemia</brief_title>
  <official_title>Specified Drug Use-Results Survey of EVRENZO® Tablets: Non-interventional, Prospective Drug Use-results Survey in the Realworld Use of EVRENZO® Tablets (Roxadustat) in Patients With Renal Anemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and efficacy, including the incidence of&#xD;
      thromboembolism, in renal anemia patients treated with roxadustat (EVRENZO® Tablets) in&#xD;
      actual clinical settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a post-marketing long-term specified drug use-result survey study required for&#xD;
      products in Japan. In the survey, patient registration and data collection will be conducted&#xD;
      using post-marketing survey data collection system, PostMaNet via the Internet.&#xD;
&#xD;
      Patients who are eligible for the survey will be registered within 14 days after the start of&#xD;
      treatment with roxadustat (including the start day of treatment). For all registered patients&#xD;
      (including discontinuations/dropouts), the investigator will enter the necessary information&#xD;
      in the case report form (CRF) and send it immediately after the end of the specified&#xD;
      observation period for each patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of participants with Adverse Drug Reactions (ADR)</measure>
    <time_frame>Up to Week 104</time_frame>
    <description>An AE is defined as any unwanted medical occurrence after drug administration and which does not necessarily have a causal relationship with the treatment.&#xD;
ADR is AEs whose relationship to the study drugs could not be ruled out is considered adverse drug reaction. AEs that fall under either &quot;Probable&quot; or &quot;Possible&quot; or &quot;Unassessable&quot; should be defined as &quot;AEs whose relationship to the study drugs could not be ruled out.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants with serious ADR</measure>
    <time_frame>Up to Week 104</time_frame>
    <description>ADR is considered &quot;serious&quot; if, in the view of the investigator, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants with thromboembolism</measure>
    <time_frame>Up to Week 104</time_frame>
    <description>Number of participants with thromboembolism compared to number of participants evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants with hypertension</measure>
    <time_frame>Up to Week 104</time_frame>
    <description>Number of participants with hypertension compared to number of participants evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants with hepatic function disorder</measure>
    <time_frame>Up to Week 104</time_frame>
    <description>Number of participants with hepatic function disorder compared to number of participants evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants with malignant tumors</measure>
    <time_frame>Up to Week 104</time_frame>
    <description>Number of participants with malignant tumors compared to number of participants evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants with retinal hemorrhage</measure>
    <time_frame>Up to Week 104</time_frame>
    <description>Number of participants with retinal hemorrhage compared to number of participants evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Participants With Seizures</measure>
    <time_frame>Up to week 104</time_frame>
    <description>Number of participants with seizures will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Participants With Serious Infection</measure>
    <time_frame>Up to week 104</time_frame>
    <description>Number of participants with serious infection will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Participants With Central Hypothyroidsm</measure>
    <time_frame>Up to Week 104</time_frame>
    <description>Number of participants with central hypothyroidsm compared to number of participants evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants with myopathy events</measure>
    <time_frame>Up to Week 104</time_frame>
    <description>Number of participants with myopathy events related to the concomitant use of hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors compared to number of participants evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Participants With Renal Function Disorder</measure>
    <time_frame>Up to week 104</time_frame>
    <description>Number of participants with renal function disorder reported as adverse drug reaction in participants with autosomal dominant polycystic kidney disease (ADPKD) will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants with ADR within 4 weeks after switching to roxadustat</measure>
    <time_frame>Up to Week 4</time_frame>
    <description>Number of participants with ADR within 4 weeks after switching from erythropoiesis stimulating agent (ESA) to roxadustat compared to number of participants evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants with ADR with high doses of roxadustat</measure>
    <time_frame>Up to Week 104</time_frame>
    <description>Number of participants with ADR with high doses of roxadustat compared to number of participants evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Hemoglobin (Hb) levels</measure>
    <time_frame>Up to Week 104</time_frame>
    <description>Hb will be recorded from blood samples collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean value of Hb levels over time</measure>
    <time_frame>Up to Week 104</time_frame>
    <description>Hb will be measured throughout the period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Achievement rate for target Hb level</measure>
    <time_frame>Up to Week 104</time_frame>
    <description>Percent of participants who achieved target Hb level (10.0 to 12.0 g/dL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Hb levels at 4 weeks after switching to roxadustat</measure>
    <time_frame>At Week 4</time_frame>
    <description>Hb levels at 4 weeks after switching from ESA to roxadustat.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2104</enrollment>
  <condition>Renal Anemia</condition>
  <arm_group>
    <arm_group_label>Roxadustat</arm_group_label>
    <description>Participants will receive oral dose of roxadustat.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Roxadustat</intervention_name>
    <description>Oral</description>
    <arm_group_label>Roxadustat</arm_group_label>
    <other_name>ASP1517</other_name>
    <other_name>Evrenzo</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Renal anemia patients on dialysis and non-dialysis who are naïve to roxadustat&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Renal anemia patients who are naïve to roxadustat.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not applicable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Astellas Pharma Inc.</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site JP00023</name>
      <address>
        <city>Aichi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00005</name>
      <address>
        <city>Akita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00002</name>
      <address>
        <city>Aomori</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00012</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00038</name>
      <address>
        <city>Ehime</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00018</name>
      <address>
        <city>Fukui</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00040</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00007</name>
      <address>
        <city>Fukushima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00021</name>
      <address>
        <city>Gifu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00010</name>
      <address>
        <city>Gunma</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00034</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00001</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00028</name>
      <address>
        <city>Hyogo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00008</name>
      <address>
        <city>Ibaraki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00017</name>
      <address>
        <city>Ishikawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00003</name>
      <address>
        <city>Iwate</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00037</name>
      <address>
        <city>Kagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00046</name>
      <address>
        <city>Kagoshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00014</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00039</name>
      <address>
        <city>Kochi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00043</name>
      <address>
        <city>Kumamoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00026</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00024</name>
      <address>
        <city>Mie</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00004</name>
      <address>
        <city>Miyagi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00045</name>
      <address>
        <city>Miyazaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00020</name>
      <address>
        <city>Nagano</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00042</name>
      <address>
        <city>Nagasaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00029</name>
      <address>
        <city>Nara</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00015</name>
      <address>
        <city>Niigata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00044</name>
      <address>
        <city>Oita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00033</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00047</name>
      <address>
        <city>Okinawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00027</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00041</name>
      <address>
        <city>Saga</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00011</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00025</name>
      <address>
        <city>Shiga</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00032</name>
      <address>
        <city>Shimane</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00022</name>
      <address>
        <city>Shizuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00009</name>
      <address>
        <city>Tochigi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00036</name>
      <address>
        <city>Tokushima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00013</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00031</name>
      <address>
        <city>Tottori</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00016</name>
      <address>
        <city>Toyama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00030</name>
      <address>
        <city>Wakayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00006</name>
      <address>
        <city>Yamagata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00035</name>
      <address>
        <city>Yamaguchi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site JP00019</name>
      <address>
        <city>Yamanashi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ASP1517</keyword>
  <keyword>Evrenzo</keyword>
  <keyword>Roxadustat</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under &quot;Sponsor Specific Details for Astellas.&quot;</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04408820
org study id: 1517-MA-3318
nct id: NCT04408820
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the safety and efficacy, including the incidence of
      thromboembolism, in renal anemia patients treated with roxadustat (EVRENZO® Tablets) in
      actual clinical settings.
This is a post-marketing long-term specified drug use-result survey study required for
      products in Japan. In the survey, patient registration and data collection will be conducted
      using post-marketing survey data collection system, PostMaNet via the Internet.

      Patients who are eligible for the survey will be registered within 14 days after the start of
      treatment with roxadustat (including the start day of treatment). For all registered patients
      (including discontinuations/dropouts), the investigator will enter the necessary information
      in the case report form (CRF) and send it immediately after the end of the specified
      observation period for each patient.
observational model: Cohort
time perspective: Prospective
measure: Proportion of participants with Adverse Drug Reactions (ADR)
time frame: Up to Week 104
description: An AE is defined as any unwanted medical occurrence after drug administration and which does not necessarily have a causal relationship with the treatment.
ADR is AEs whose relationship to the study drugs could not be ruled out is considered adverse drug reaction. AEs that fall under either "Probable" or "Possible" or "Unassessable" should be defined as "AEs whose relationship to the study drugs could not be ruled out.
measure: Proportion of participants with serious ADR
time frame: Up to Week 104
description: ADR is considered "serious" if, in the view of the investigator, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.
measure: Proportion of participants with thromboembolism
time frame: Up to Week 104
description: Number of participants with thromboembolism compared to number of participants evaluated.
measure: Proportion of participants with hypertension
time frame: Up to Week 104
description: Number of participants with hypertension compared to number of participants evaluated.
measure: Proportion of participants with hepatic function disorder
time frame: Up to Week 104
description: Number of participants with hepatic function disorder compared to number of participants evaluated.
measure: Proportion of participants with malignant tumors
time frame: Up to Week 104
description: Number of participants with malignant tumors compared to number of participants evaluated.
measure: Proportion of participants with retinal hemorrhage
time frame: Up to Week 104
description: Number of participants with retinal hemorrhage compared to number of participants evaluated.
measure: Proportion of Participants With Seizures
time frame: Up to week 104
description: Number of participants with seizures will be reported.
measure: Proportion of Participants With Serious Infection
time frame: Up to week 104
description: Number of participants with serious infection will be reported.
measure: Proportion of Participants With Central Hypothyroidsm
time frame: Up to Week 104
description: Number of participants with central hypothyroidsm compared to number of participants evaluated.
measure: Proportion of participants with myopathy events
time frame: Up to Week 104
description: Number of participants with myopathy events related to the concomitant use of hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitors compared to number of participants evaluated.
measure: Proportion of Participants With Renal Function Disorder
time frame: Up to week 104
description: Number of participants with renal function disorder reported as adverse drug reaction in participants with autosomal dominant polycystic kidney disease (ADPKD) will be reported.
measure: Proportion of participants with ADR within 4 weeks after switching to roxadustat
time frame: Up to Week 4
description: Number of participants with ADR within 4 weeks after switching from erythropoiesis stimulating agent (ESA) to roxadustat compared to number of participants evaluated.
measure: Proportion of participants with ADR with high doses of roxadustat
time frame: Up to Week 104
description: Number of participants with ADR with high doses of roxadustat compared to number of participants evaluated.
measure: Change from baseline in Hemoglobin (Hb) levels
time frame: Up to Week 104
description: Hb will be recorded from blood samples collected.
measure: Mean value of Hb levels over time
time frame: Up to Week 104
description: Hb will be measured throughout the period.
measure: Achievement rate for target Hb level
time frame: Up to Week 104
description: Percent of participants who achieved target Hb level (10.0 to 12.0 g/dL).
measure: Mean Hb levels at 4 weeks after switching to roxadustat
time frame: At Week 4
description: Hb levels at 4 weeks after switching from ESA to roxadustat.
arm group label: Roxadustat
description: Participants will receive oral dose of roxadustat.
intervention type: Drug
intervention name: Roxadustat
description: Oral
arm group label: Roxadustat
other name: ASP1517
other name: Evrenzo
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Astellas Pharma Inc.
role: Study Director
affiliation: Astellas Pharma Inc
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country: Japan
responsible party type: Sponsor
mesh term: Anemia
sharing ipd: No
ipd description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."