<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/NCT04502537</url>
  </required_header>
  <id_info>
    <org_study_id>20203357012</org_study_id>
    <nct_id>NCT04502537</nct_id>
  </id_info>
  <brief_title>Roxadustat for Anemia in Patients With CKD</brief_title>
  <official_title>A Prospective Cohort Study of Roxadustat for Anemia in Patients With Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shenzhen Second People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shenzhen Second People's Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A number of RCT studies have shown the safety and effectiveness of oral Roxadustat in the&#xD;
      treatment of renal anemia, but there is a lack of evidence from cohort studies. A prospective&#xD;
      cohort study is planed to conduct to evaluate the efficacy and safety of Roxadustat for renal&#xD;
      anemia in the real world.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of anemia in patients with chronic kidney disease (CKD) (15.4%) is twice that&#xD;
      of the general population (7.6%), and the degree of anemia increases with the severity of&#xD;
      CKD. A number of RCT studies have shown the safety and effectiveness of oral Roxadustat in&#xD;
      the treatment of renal anemia, but there is a lack of evidence from cohort studies. A&#xD;
      prospective cohort study is planed to conduct to evaluate the efficacy and safety of&#xD;
      Roxadustat for renal anemia in the real world. It is planned to continuously recruit patients&#xD;
      with renal anemia in Shenzhen Second People's Hospital from October 2020 to June 2023. The&#xD;
      treatment of anemia will be recorded (Roxadustat or erythropoietin), and the observation&#xD;
      period is one year. Collect the patient's demographic characteristics, drug dosage,&#xD;
      adjustment plan, hemoglobin. The main outcome indicators were: the average change in Hb from&#xD;
      baseline to 28-52 weeks, and the Hb response rate reached during two consecutive visits; the&#xD;
      secondary outcome indicators were: the maintenance rate of the target Hb level, iron&#xD;
      metabolism indicators, 0 to 8 weeks of Hb level increase rate, dose adjustment and safety&#xD;
      indicators. The generalized additive mixed model of repeated measures was used to analyze the&#xD;
      changes and differences of outcome indicators in different groups. Expected results: In the&#xD;
      cohort study, the effectiveness and safety of roxastat in the treatment of renal anemia, the&#xD;
      starting dose and the adjustment plan, provide a basis for guiding the clinical safe and&#xD;
      effective application of roxastat.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">February 1, 2021</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</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>Mean value of Hb levels over time</measure>
    <time_frame>Up to Week 52</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 52</time_frame>
    <description>Percent of participants who achieved target Hb level (≥10.0 ).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Hb levels at 4 weeks after using roxadustat</measure>
    <time_frame>At Week 4</time_frame>
    <description>Hb levels at 4 weeks after using roxadustat</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Hb levels at 8 weeks after using roxadustat</measure>
    <time_frame>At Week 8</time_frame>
    <description>Hb levels at 8 weeks after using roxadustat</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the dose of Roxadustat used</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>the dose of Roxadustat used recorded monthly</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Hemoglobin (Hb) levels</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Change from baseline in Hemoglobin (Hb) levels was recorded monthly</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the proportion of patients with different Hb levels</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>the proportion of patients with different Hb levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients with low response to ESA</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>The proportion of patients with low response to ESA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Serum iron</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Serum iron will be measured throughout the period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with adverse events</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>adverse events will be record throughout the period.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Anemia of Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Roxadustat</arm_group_label>
    <description>treatment with roxadustat</description>
  </arm_group>
  <arm_group>
    <arm_group_label>erythropoietin</arm_group_label>
    <description>treatment with erythropoietin</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>Roxadustat capsules</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>erythropoietin</intervention_name>
    <description>injection</description>
    <arm_group_label>erythropoietin</arm_group_label>
    <other_name>Recombinant Human Erythropoietin Injection(CHO cell)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Renal anemia patients who are naïve to roxadustat or ESA&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. the patient did not receive ESA treatment.The average Hb level of the last two (at&#xD;
             least 7 days before the start of the study treatment and during the screening period)&#xD;
             was &lt;10 g/dL.&#xD;
&#xD;
             Or patients who have received ESA:&#xD;
&#xD;
             Patients with renal anemia who received ESA for at least 4 weeks within the approved&#xD;
             dose range in China before the screening evaluation.&#xD;
&#xD;
          2. The average Hb level of the last two (at least 7 days before the start of the study&#xD;
             treatment and during the screening period) &gt;=7 g/dL and &lt;=12.0 g/dL;&#xD;
&#xD;
          3. The expected survival time is more than 1 year;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. a history of severe, chronic, end-stage or uncontrolled autoimmune liver disease,&#xD;
             Child Pugh score was grade C, or with active hepatitis;&#xD;
&#xD;
          2. preparing for pregnancy or pregnancy or lactation;&#xD;
&#xD;
          3. having anemia caused by any other disease other than CKD, such as thalassemia, sickle&#xD;
             cell anemia, pure red aplastic anemia, hemolytic anemia, tumor-related anemia,&#xD;
             chemotherapy-related anemia, and myelodysplastic syndrome;&#xD;
&#xD;
          4. malignant tumor, such as prostate cancer, breast cancer, renal cell cancer or any&#xD;
             other malignant tumor history or diagnosed&#xD;
&#xD;
          5. .Any red blood cell infusion during the screening period;&#xD;
&#xD;
          6. The patient is known to be allergic to the active substance (Roxadustat) or any&#xD;
             excipient of the product;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuan Cheng, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shenzhen Second People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yuan Cheng, Dr.</last_name>
    <phone>86075583366388</phone>
    <email>chengy_nephrology@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Qijun Wan, Dr.</last_name>
    <phone>86075583366388</phone>
    <email>yiyuan2224@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shenzhen Second People's Hospital</name>
      <address>
        <city>Shenzhen</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuan Cheng</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>January 19, 2021</last_update_submitted>
  <last_update_submitted_qc>January 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</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>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Anemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epoetin Alfa</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04502537
org study id: 20203357012
nct id: NCT04502537
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
A number of RCT studies have shown the safety and effectiveness of oral Roxadustat in the
      treatment of renal anemia, but there is a lack of evidence from cohort studies. A prospective
      cohort study is planed to conduct to evaluate the efficacy and safety of Roxadustat for renal
      anemia in the real world.
The prevalence of anemia in patients with chronic kidney disease (CKD) (15.4%) is twice that
      of the general population (7.6%), and the degree of anemia increases with the severity of
      CKD. A number of RCT studies have shown the safety and effectiveness of oral Roxadustat in
      the treatment of renal anemia, but there is a lack of evidence from cohort studies. A
      prospective cohort study is planed to conduct to evaluate the efficacy and safety of
      Roxadustat for renal anemia in the real world. It is planned to continuously recruit patients
      with renal anemia in Shenzhen Second People's Hospital from October 2020 to June 2023. The
      treatment of anemia will be recorded (Roxadustat or erythropoietin), and the observation
      period is one year. Collect the patient's demographic characteristics, drug dosage,
      adjustment plan, hemoglobin. The main outcome indicators were: the average change in Hb from
      baseline to 28-52 weeks, and the Hb response rate reached during two consecutive visits; the
      secondary outcome indicators were: the maintenance rate of the target Hb level, iron
      metabolism indicators, 0 to 8 weeks of Hb level increase rate, dose adjustment and safety
      indicators. The generalized additive mixed model of repeated measures was used to analyze the
      changes and differences of outcome indicators in different groups. Expected results: In the
      cohort study, the effectiveness and safety of roxastat in the treatment of renal anemia, the
      starting dose and the adjustment plan, provide a basis for guiding the clinical safe and
      effective application of roxastat.
observational model: Cohort
time perspective: Prospective
measure: Mean value of Hb levels over time
time frame: Up to Week 52
description: Hb will be measured throughout the period.
measure: Achievement rate for target Hb level
time frame: Up to Week 52
description: Percent of participants who achieved target Hb level (≥10.0 ).
measure: Mean Hb levels at 4 weeks after using roxadustat
time frame: At Week 4
description: Hb levels at 4 weeks after using roxadustat
measure: Mean Hb levels at 8 weeks after using roxadustat
time frame: At Week 8
description: Hb levels at 8 weeks after using roxadustat
measure: the dose of Roxadustat used
time frame: Up to Week 52
description: the dose of Roxadustat used recorded monthly
measure: Change from baseline in Hemoglobin (Hb) levels
time frame: Up to Week 52
description: Change from baseline in Hemoglobin (Hb) levels was recorded monthly
measure: the proportion of patients with different Hb levels
time frame: Up to Week 52
description: the proportion of patients with different Hb levels
measure: The proportion of patients with low response to ESA
time frame: Up to Week 52
description: The proportion of patients with low response to ESA
measure: Concentration of Serum iron
time frame: Up to Week 52
description: Serum iron will be measured throughout the period.
measure: Number of Participants with adverse events
time frame: Up to Week 52
description: adverse events will be record throughout the period.
arm group label: Roxadustat
description: treatment with roxadustat
arm group label: erythropoietin
description: treatment with erythropoietin
intervention type: Drug
intervention name: Roxadustat
description: Oral
arm group label: Roxadustat
other name: Roxadustat capsules
intervention type: Drug
intervention name: erythropoietin
description: injection
arm group label: erythropoietin
other name: Recombinant Human Erythropoietin Injection(CHO cell)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yuan Cheng, Dr.
role: Principal Investigator
affiliation: Shenzhen Second People's Hospital
last name: Yuan Cheng, Dr.
phone: 86075583366388
email: chengy_nephrology@163.com
last name: Qijun Wan, Dr.
phone: 86075583366388
email: yiyuan2224@sina.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Anemia
mesh term: Epoetin Alfa
sharing ipd: Undecided