xml: <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/NCT05969522</url>
    </required_header>
    <id_info>
      <org_study_id>ANCA20230706</org_study_id>
      <nct_id>NCT05969522</nct_id>
    </id_info>
    <brief_title>Stratified Therapy on Pediatric AAGN</brief_title>
    <acronym>STPARS</acronym>
    <official_title>Stratified Therapy on Pediatric AAGN Based on Risk Assessment-A Prospective, Multicenter, Open, Tendentious Matched Control Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wang Mo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Children's Hospital of Chongqing Medical University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Clinical information of children with ANCA-associated nephritis admitted to Children's&#xD;
        Hospital Affiliated to Chongqing Medical University and partner centers from January 1, 2023&#xD;
        to December 31, 2023 was collected:&#xD;
  &#xD;
        To evaluate and compare the differences in survival, renal outcomes, and adverse reactions in&#xD;
        children with ANCA-associated nephritis given different interventions according to the&#xD;
        revised PARRG risk stratification, and to evaluate the superiority of ANCA-associated&#xD;
        nephritis given according to the revised PARRG risk stratification.&#xD;
  &#xD;
        (2) To evaluate the efficacy and safety of glucocorticoid combined with rituximab and&#xD;
        cyclophosphamide as induction regimen in high-risk group and glucocorticoid combined with&#xD;
        rituximab as induction regimen in children with ANCA-associated nephritis (AAGN) in low and&#xD;
        middle risk group based on PARRG risk stratification&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Response rate (complete and partial response rate)</measure>
      <time_frame>6 months</time_frame>
      <description>The rate of complete or partial response to ANCA vasculitis-associated nephritis (AAGN) was assessed at 6 months. Complete AAGN response was defined as: 1. Estimated glomerular filtration rate (eGFR) ≥60ml/min/1.73m2, or a decrease of less than 15% from baseline eGFR; 2. Proteinuria ≤0.3g/24 hours.Partial AAGN response was defined as: 1. Estimated glomerular filtration rate (eGFR) ≥30ml/min/1.73m2, or a reduction of less than 50% from baseline eGFR; 2. Decreased proteinuria&gt;Baseline 50% or 24-hour urinary protein quantification&lt;50mg/Kg.d.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The time to achieve complete and partial AAGN remission</measure>
      <time_frame>6 months</time_frame>
      <description>The time to achieve complete and partial AAGN remission</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis</condition>
    <condition>ANCA-Associated Glomerulonephritis</condition>
    <arm_group>
      <arm_group_label>Control group-Low and medium risk group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The children with AAGN admitted to all cooperating units during 2017.01.01 to 2022.12.31 were followed up for more than 6 months, and the case data were complete.&#xD;
  PARRG Classification (pediatric AAGN renal risk grade, pediatric AAV renal risk grade, PARRG) According to the PARRG grading method provided by the Affiliated Children's Hospital of Chongqing Medical University, the enrolled children with AAGN were classified into high risk group, medium risk group, low risk group, medium risk group, low risk combination and low risk group according to the two indexes of eGFR and percentage of glomerular sclerosis during renal biopsy.&#xD;
  PARRG risk grading criteria:&#xD;
  There are two risk factors for ESRD: (1) eGFR≤20ml/min/1.73m2 at renal biopsy; ② The proportion of glomerular sclerosis ≥30%; High risk resistance: meet 2 risk factors; Moderate risk group: only 1 risk factor; Low risk group: no above risk factors;</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group-High risk group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The children with AAGN admitted to all cooperating units during 2017.01.01 to 2022.12.31 were followed up for more than 6 months, and the case data were complete.&#xD;
  PARRG Classification (pediatric AAGN renal risk grade, pediatric AAV renal risk grade, PARRG) According to the PARRG grading method provided by the Affiliated Children's Hospital of Chongqing Medical University, the enrolled children with AAGN were classified into high risk group, medium risk group, low risk group, medium risk group, low risk combination and low risk group according to the two indexes of eGFR and percentage of glomerular sclerosis during renal biopsy.&#xD;
  PARRG risk grading criteria:&#xD;
  There are two risk factors for ESRD: (1) eGFR≤20ml/min/1.73m2 at renal biopsy; ② The proportion of glomerular sclerosis ≥30%; High risk resistance: meet 2 risk factors; Moderate risk group: only 1 risk factor; Low risk group: no above risk factors;</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental group-Low and medium risk group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Newly diagnosed children with AAGN admitted to our partners during the period of 2023.01.01 to 2023.12.31.&#xD;
  All children with AAGN were PARRG risk graded before treatment with RTX and CTX:&#xD;
  PARRG Classification (pediatric AAGN renal risk grade, pediatric AAV renal risk grade, PARRG) According to the PARRG grading method provided by the Affiliated Children's Hospital of Chongqing Medical University, the enrolled children with AAGN were classified into high risk group, medium risk group, low risk group, medium risk group, low risk combination and low risk group according to the two indexes of eGFR and percentage of glomerular sclerosis during renal biopsy.&#xD;
  PARRG risk grading criteria:&#xD;
  There are two risk factors for ESRD: (1) eGFR≤20ml/min/1.73m2 at renal biopsy; ② The proportion of glomerular sclerosis ≥30%; High risk resistance: meet 2 risk factors; Moderate risk group: only 1 risk factor; Low risk group: no above risk factors;</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental group-High risk group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Newly diagnosed children with AAGN admitted to our partners during the period of 2023.01.01 to 2023.12.31.&#xD;
  All children with AAGN were PARRG risk graded before treatment with RTX and CTX:&#xD;
  PARRG Classification (pediatric AAGN renal risk grade, pediatric AAV renal risk grade, PARRG) According to the PARRG grading method provided by the Affiliated Children's Hospital of Chongqing Medical University, the enrolled children with AAGN were classified into high risk group, medium risk group, low risk group, medium risk group, low risk combination and low risk group according to the two indexes of eGFR and percentage of glomerular sclerosis during renal biopsy.&#xD;
  PARRG risk grading criteria:&#xD;
  There are two risk factors for ESRD: (1) eGFR≤20ml/min/1.73m2 at renal biopsy; ② The proportion of glomerular sclerosis ≥30%; High risk resistance: meet 2 risk factors; Moderate risk group: only 1 risk factor; Low risk group: no above risk factors;</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>GlucoCorticoid</intervention_name>
      <description>The high-risk group: methylprednisolone intravenous 15-30mg/kg/d (Max.500mg/d)*3 days , with 2 courses, interval 5-7 days;Oral prednisone acetate 1.5-2mg/kg/d (Max. 60mg/d) during methylprednisolone impact interval and later stage, with the first reduction after 2-4 weeks. The dose was reduced once every 3 weeks in the first 3 months, and once every 4 weeks in the next 3 months, with a reduction of 5-10mg/ day each time; Rituximab：375 mg/m2/ time, once a week for 4 times;Intravenous cyclophosphamide 7.5-10mg/kg.d*2 days(Max.500mg/d), once every 4 weeks, twice in total, at the 8th and 12th week.The medium-low risk group: methylprednisolone was the same dose as before, but only with 1 course, then followed by oral prednisone acetate 1.5-2mg/kg/d (Max. 60mg/d), divided into three times for 3 weeks, and then changed to morning daily; The dose was reduced as the high-risk group ;Rituximab was the same dose as before.</description>
      <arm_group_label>Control group-High risk group</arm_group_label>
      <arm_group_label>Control group-Low and medium risk group</arm_group_label>
      <arm_group_label>Experimental group-High risk group</arm_group_label>
      <arm_group_label>Experimental group-Low and medium risk group</arm_group_label>
      <other_name>Rituximab</other_name>
      <other_name>Cyclophosphamide</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1) Newly diagnosed AAGN patients with onset age of 5-17 years, complete renal biopsy&#xD;
               and regular follow-up in the hospital; 2) All enrolled children met the following&#xD;
               inclusion criteria: ANCA classification criteria: Patients who meet the 2007 European&#xD;
               Medicines Agency (EMA) classification algorithm or the 2012 CHCC definition. Clinical&#xD;
               classification includes: micropolyvasculitis (MPA), granulomatous polyvasculitis (GPA)&#xD;
               and eosinophilic granulomatous polyvasculitis (EGPA);&#xD;
  &#xD;
          AAGN diagnostic criteria: ANCA vasculitis combined with any of the following:&#xD;
  &#xD;
            1. Hematuria: gross hematuria or microscopic hematuria: 3 times microscopic hematuria&#xD;
               within 1 week: red blood cells &amp;gt in urine routine; 3 / high magnification field (HP)&#xD;
               or &gt; 17 /ul (higher than normal value, can be adjusted according to the standard of&#xD;
               the laboratory of each center);&#xD;
  &#xD;
            2. proteinuria: meet any of the following: ① 3 times in 1 week urine routine protein&#xD;
               positive; 2) 24h urinary protein quantification &amp;gt; 150 mg or urinary&#xD;
               protein/creatinine (mg/mg)&amp;gt; 0.2; 3 urinary microalbumin higher than normal for 3&#xD;
               times in 1 week;&#xD;
  &#xD;
            3. Renal insufficiency: increased serum creatinine &amp;gt; 10% base or decreased creatinine&#xD;
               clearance &amp;gt; 25%.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - 1) Patients who relied on dialysis for more than 1 month at the time of diagnosis, or the&#xD;
          proportion of glomerular sclerosis ≥75% at the time of renal biopsy; 2) Patients with&#xD;
          severe infection (such as diffuse peritonitis, severe pneumonia, cellulitis, active&#xD;
          Epstein-Barr virus infection, active cytomegalovirus infection, hepatitis B virus&#xD;
          infection, tuberculosis infection, fungal infection, etc.) and tumor.&#xD;
  &#xD;
          3) Patients with other primary or secondary kidney diseases (such as IgA nephropathy,&#xD;
          membranous nephropathy, anti-glomerular basement membrane nephritis, polycystic kidney&#xD;
          disease, renal dysplasia, urinary tract malformation, etc.); 4) Parents or children refused&#xD;
          to join the group.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>mo Wang</last_name>
      <role>Study Director</role>
      <affiliation>Children's Hospital of Chongqing Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>cheng Zhong</last_name>
      <phone>15823857537</phone>
      <email>zhongcheng_cy2018@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>fu g Zhang</last_name>
      <phone>13883058878</phone>
      <email>zhanggaofu19992004@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Children's Hospital of Chongqing Medical University</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <zip>400015</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>cheng Zhong</last_name>
        <phone>15823857537</phone>
        <email>zhongcheng_cy2018@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Children's Hospital of Chongqing Medical University</investigator_affiliation>
      <investigator_full_name>Wang Mo</investigator_full_name>
      <investigator_title>Professor/Chief Physician</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glomerulonephritis</mesh_term>
      <mesh_term>Vasculitis</mesh_term>
      <mesh_term>Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cyclophosphamide</mesh_term>
      <mesh_term>Glucocorticoids</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05969522
  org study id: ANCA20230706
  nct id: NCT05969522
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Clinical information of children with ANCA-associated nephritis admitted to Children's
        Hospital Affiliated to Chongqing Medical University and partner centers from January 1, 2023
        to December 31, 2023 was collected:
  
        To evaluate and compare the differences in survival, renal outcomes, and adverse reactions in
        children with ANCA-associated nephritis given different interventions according to the
        revised PARRG risk stratification, and to evaluate the superiority of ANCA-associated
        nephritis given according to the revised PARRG risk stratification.
  
        (2) To evaluate the efficacy and safety of glucocorticoid combined with rituximab and
        cyclophosphamide as induction regimen in high-risk group and glucocorticoid combined with
        rituximab as induction regimen in children with ANCA-associated nephritis (AAGN) in low and
        middle risk group based on PARRG risk stratification
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Response rate (complete and partial response rate)
  time frame: 6 months
  description: The rate of complete or partial response to ANCA vasculitis-associated nephritis (AAGN) was assessed at 6 months. Complete AAGN response was defined as: 1. Estimated glomerular filtration rate (eGFR) ≥60ml/min/1.73m2, or a decrease of less than 15% from baseline eGFR; 2. Proteinuria ≤0.3g/24 hours.Partial AAGN response was defined as: 1. Estimated glomerular filtration rate (eGFR) ≥30ml/min/1.73m2, or a reduction of less than 50% from baseline eGFR; 2. Decreased proteinuria>Baseline 50% or 24-hour urinary protein quantification<50mg/Kg.d.
  measure: The time to achieve complete and partial AAGN remission
  time frame: 6 months
  description: The time to achieve complete and partial AAGN remission
  arm group label: Control group-Low and medium risk group
  arm group type: Other
  description: The children with AAGN admitted to all cooperating units during 2017.01.01 to 2022.12.31 were followed up for more than 6 months, and the case data were complete.
  PARRG Classification (pediatric AAGN renal risk grade, pediatric AAV renal risk grade, PARRG) According to the PARRG grading method provided by the Affiliated Children's Hospital of Chongqing Medical University, the enrolled children with AAGN were classified into high risk group, medium risk group, low risk group, medium risk group, low risk combination and low risk group according to the two indexes of eGFR and percentage of glomerular sclerosis during renal biopsy.
  PARRG risk grading criteria:
  There are two risk factors for ESRD: (1) eGFR≤20ml/min/1.73m2 at renal biopsy; ② The proportion of glomerular sclerosis ≥30%; High risk resistance: meet 2 risk factors; Moderate risk group: only 1 risk factor; Low risk group: no above risk factors;
  arm group label: Control group-High risk group
  arm group type: Other
  description: The children with AAGN admitted to all cooperating units during 2017.01.01 to 2022.12.31 were followed up for more than 6 months, and the case data were complete.
  PARRG Classification (pediatric AAGN renal risk grade, pediatric AAV renal risk grade, PARRG) According to the PARRG grading method provided by the Affiliated Children's Hospital of Chongqing Medical University, the enrolled children with AAGN were classified into high risk group, medium risk group, low risk group, medium risk group, low risk combination and low risk group according to the two indexes of eGFR and percentage of glomerular sclerosis during renal biopsy.
  PARRG risk grading criteria:
  There are two risk factors for ESRD: (1) eGFR≤20ml/min/1.73m2 at renal biopsy; ② The proportion of glomerular sclerosis ≥30%; High risk resistance: meet 2 risk factors; Moderate risk group: only 1 risk factor; Low risk group: no above risk factors;
  arm group label: Experimental group-Low and medium risk group
  arm group type: Experimental
  description: Newly diagnosed children with AAGN admitted to our partners during the period of 2023.01.01 to 2023.12.31.
  All children with AAGN were PARRG risk graded before treatment with RTX and CTX:
  PARRG Classification (pediatric AAGN renal risk grade, pediatric AAV renal risk grade, PARRG) According to the PARRG grading method provided by the Affiliated Children's Hospital of Chongqing Medical University, the enrolled children with AAGN were classified into high risk group, medium risk group, low risk group, medium risk group, low risk combination and low risk group according to the two indexes of eGFR and percentage of glomerular sclerosis during renal biopsy.
  PARRG risk grading criteria:
  There are two risk factors for ESRD: (1) eGFR≤20ml/min/1.73m2 at renal biopsy; ② The proportion of glomerular sclerosis ≥30%; High risk resistance: meet 2 risk factors; Moderate risk group: only 1 risk factor; Low risk group: no above risk factors;
  arm group label: Experimental group-High risk group
  arm group type: Experimental
  description: Newly diagnosed children with AAGN admitted to our partners during the period of 2023.01.01 to 2023.12.31.
  All children with AAGN were PARRG risk graded before treatment with RTX and CTX:
  PARRG Classification (pediatric AAGN renal risk grade, pediatric AAV renal risk grade, PARRG) According to the PARRG grading method provided by the Affiliated Children's Hospital of Chongqing Medical University, the enrolled children with AAGN were classified into high risk group, medium risk group, low risk group, medium risk group, low risk combination and low risk group according to the two indexes of eGFR and percentage of glomerular sclerosis during renal biopsy.
  PARRG risk grading criteria:
  There are two risk factors for ESRD: (1) eGFR≤20ml/min/1.73m2 at renal biopsy; ② The proportion of glomerular sclerosis ≥30%; High risk resistance: meet 2 risk factors; Moderate risk group: only 1 risk factor; Low risk group: no above risk factors;
  intervention type: Drug
  intervention name: GlucoCorticoid
  description: The high-risk group: methylprednisolone intravenous 15-30mg/kg/d (Max.500mg/d)*3 days , with 2 courses, interval 5-7 days;Oral prednisone acetate 1.5-2mg/kg/d (Max. 60mg/d) during methylprednisolone impact interval and later stage, with the first reduction after 2-4 weeks. The dose was reduced once every 3 weeks in the first 3 months, and once every 4 weeks in the next 3 months, with a reduction of 5-10mg/ day each time; Rituximab：375 mg/m2/ time, once a week for 4 times;Intravenous cyclophosphamide 7.5-10mg/kg.d*2 days(Max.500mg/d), once every 4 weeks, twice in total, at the 8th and 12th week.The medium-low risk group: methylprednisolone was the same dose as before, but only with 1 course, then followed by oral prednisone acetate 1.5-2mg/kg/d (Max. 60mg/d), divided into three times for 3 weeks, and then changed to morning daily; The dose was reduced as the high-risk group ;Rituximab was the same dose as before.
  arm group label: Control group-High risk group
  arm group label: Control group-Low and medium risk group
  arm group label: Experimental group-High risk group
  arm group label: Experimental group-Low and medium risk group
  other name: Rituximab
  other name: Cyclophosphamide
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: mo Wang
  role: Study Director
  affiliation: Children's Hospital of Chongqing Medical University
  last name: cheng Zhong
  phone: 15823857537
  email: zhongcheng_cy2018@163.com
  last name: fu g Zhang
  phone: 13883058878
  email: zhanggaofu19992004@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Children's Hospital of Chongqing Medical University
  investigator full name: Wang Mo
  investigator title: Professor/Chief Physician
  mesh term: Glomerulonephritis
  mesh term: Vasculitis
  mesh term: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
  mesh term: Cyclophosphamide
  mesh term: Glucocorticoids