<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/NCT04454879</url>
  </required_header>
  <id_info>
    <org_study_id>Roxadustat，different dose,</org_study_id>
    <nct_id>NCT04454879</nct_id>
  </id_info>
  <brief_title>Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients</brief_title>
  <official_title>Different Doses of Roxadustat Treatment on Hemoglobin Target-met in Peritoneal Dialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Haidian Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multi-center, randomized, controlled study to evaluate the effect of different doses of&#xD;
      roxadustate on hemoglobin target-met in peritoneal dialysis patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Roxadustat is an orally hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to&#xD;
      promote erythropoiesis on patients with chronic kidney disease. Two phase 3 clinical trials&#xD;
      have verified the efficacy and safety of roxadustate as therapy for anemia in patients with&#xD;
      CKD and undergoing dialysis. A high increasing rate of Hb or Hb overshooting triggered by&#xD;
      roxadustat need dosing reduction or even drug withdrawal, possibly leading to a large Hb&#xD;
      variation and adverse subsequences. Therefore, we were of interest to investigate whether a&#xD;
      lower starting dose of roxadustat could achieve comparable Hb target at week 12 while&#xD;
      lowering the risk for Hb over 130g/L through a prospective peritoneal dialysis (PD) cohort.&#xD;
      Peritoneal dialysis patients diagnosed with renal anemia will be divided into standard&#xD;
      roxadustat dosage group and lower roxadustat dosage group. After 12 weeks, we will compare&#xD;
      the target-met, overshooting and variation ratio of hemoglobin between these two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">August 3, 2021</completion_date>
  <primary_completion_date type="Actual">April 3, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The ratio of hemoglobin achieving the target (115g/L)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The ratio of hemoglobin achieving the target (115g/L) on week 8 and week 12.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The variation ratio of hemoglobin</measure>
    <time_frame>12 weeks</time_frame>
    <description>The standard deviation of hemoglobin during the follow-up divide by average of hemoglobin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The ratio of hemoglobin over-shooting</measure>
    <time_frame>12 weeks</time_frame>
    <description>Hemoglobin higher than 130g/L during the follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Renal Anemia</condition>
  <arm_group>
    <arm_group_label>standard roxadustat dosage group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Peritoneal dialysis patients diagnosed with renal anemia will receive standard dosage of roxadustat according to weight.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lower roxadustat dosage group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Peritoneal dialysis patients diagnosed with renal anemia will receive lower dosage of roxadustat according to weight.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Roxadustat</intervention_name>
    <description>Patients in the standard dosage group will receive starting dosage of roxadustat 100 mg, three times per week for weight 45-60kg and 120 mg, three times per week for weight greater than 60kg. Patients in the lower dosage group will receive the starting dosage of roxadustat 50 mg, three times per week for weight lower than 50kg, 70 mg, three times per week for weight 50-70kg, 90 mg, three times per week for weight 70-90kg and 110 mg, three times per week for weight 90-110kg, respectively.</description>
    <arm_group_label>lower roxadustat dosage group</arm_group_label>
    <arm_group_label>standard roxadustat dosage group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients diagnosed with Chronic kidney disease stage 5&#xD;
&#xD;
          2. Maintenance on PD for more than three months.&#xD;
&#xD;
          3. Weight between 45Kg and 110Kg&#xD;
&#xD;
          4. Renal anemia, and hemoglobin between 90g/L and 120g/L&#xD;
&#xD;
          5. Stop taking erythropoietin for enough time （erythropoietin treatment discontinuation&#xD;
             for ≥3 days if using erythropoietin of 3000U single strength, or ≥7 days if using&#xD;
             erythropoietin of 10000U single strength） or free of erythropoietin use&#xD;
&#xD;
          6. Signed the informed consent.&#xD;
&#xD;
          7. Willing to follow the study procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hematologic malignancy or aplastic anemia.&#xD;
&#xD;
          2. Blood loss or hemolysis.&#xD;
&#xD;
          3. Taking roxadustat, or Allergy or intolerance to roxadustat&#xD;
&#xD;
          4. Severe liver injury or active hepatitis.&#xD;
&#xD;
          5. Pregnancy or breastfeeding&#xD;
&#xD;
          6. Cancer, receiving radiotherapy and chemotherapy within 6 months.&#xD;
&#xD;
          7. Refractory hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jie Dong, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking University First Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>November 24, 2021</last_update_submitted>
  <last_update_submitted_qc>November 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Dong Jie</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Roxadustat</keyword>
  <keyword>renal anemia</keyword>
  <keyword>Peritoneal Dialysis</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>
  </patient_data>
  <pending_results>
    <submitted>October 17, 2022</submitted>
    <returned>November 9, 2022</returned>
    <submitted>April 21, 2023</submitted>
    <returned>May 16, 2023</returned>
  </pending_results>
  <!-- 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/NCT04454879
org study id: Roxadustat，different dose,
nct id: NCT04454879
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
A multi-center, randomized, controlled study to evaluate the effect of different doses of
      roxadustate on hemoglobin target-met in peritoneal dialysis patients
Roxadustat is an orally hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to
      promote erythropoiesis on patients with chronic kidney disease. Two phase 3 clinical trials
      have verified the efficacy and safety of roxadustate as therapy for anemia in patients with
      CKD and undergoing dialysis. A high increasing rate of Hb or Hb overshooting triggered by
      roxadustat need dosing reduction or even drug withdrawal, possibly leading to a large Hb
      variation and adverse subsequences. Therefore, we were of interest to investigate whether a
      lower starting dose of roxadustat could achieve comparable Hb target at week 12 while
      lowering the risk for Hb over 130g/L through a prospective peritoneal dialysis (PD) cohort.
      Peritoneal dialysis patients diagnosed with renal anemia will be divided into standard
      roxadustat dosage group and lower roxadustat dosage group. After 12 weeks, we will compare
      the target-met, overshooting and variation ratio of hemoglobin between these two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The ratio of hemoglobin achieving the target (115g/L)
time frame: 12 weeks
description: The ratio of hemoglobin achieving the target (115g/L) on week 8 and week 12.
measure: The variation ratio of hemoglobin
time frame: 12 weeks
description: The standard deviation of hemoglobin during the follow-up divide by average of hemoglobin
measure: The ratio of hemoglobin over-shooting
time frame: 12 weeks
description: Hemoglobin higher than 130g/L during the follow-up.
arm group label: standard roxadustat dosage group
arm group type: Experimental
description: Peritoneal dialysis patients diagnosed with renal anemia will receive standard dosage of roxadustat according to weight.
arm group label: lower roxadustat dosage group
arm group type: Experimental
description: Peritoneal dialysis patients diagnosed with renal anemia will receive lower dosage of roxadustat according to weight.
intervention type: Drug
intervention name: Roxadustat
description: Patients in the standard dosage group will receive starting dosage of roxadustat 100 mg, three times per week for weight 45-60kg and 120 mg, three times per week for weight greater than 60kg. Patients in the lower dosage group will receive the starting dosage of roxadustat 50 mg, three times per week for weight lower than 50kg, 70 mg, three times per week for weight 50-70kg, 90 mg, three times per week for weight 70-90kg and 110 mg, three times per week for weight 90-110kg, respectively.
arm group label: lower roxadustat dosage group
arm group label: standard roxadustat dosage group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jie Dong, MD
role: Study Director
affiliation: Peking University First Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Dong Jie
investigator title: Clinical Professor
mesh term: Anemia
sharing ipd: No
submitted: October 17, 2022
returned: November 9, 2022
submitted: April 21, 2023
returned: May 16, 2023