<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/NCT04438603</url>
  </required_header>
  <id_info>
    <org_study_id>XHEC-C-2020-070-1</org_study_id>
    <nct_id>NCT04438603</nct_id>
  </id_info>
  <brief_title>The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy</brief_title>
  <official_title>The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</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>
      This prospective study aims to investigate the role of IR-Seq in the diagnosis and disease&#xD;
      monitoring in patients with IgA nephropathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Autoimmunity may play an important role in IgA nephropathy, and previous studies have shown&#xD;
      that immune repertoire sequencing (IR-Seq) may help elucidate the dynamic changes of immune&#xD;
      repertoire (IR) in autoimmune disease states. To further explore the potential application&#xD;
      value of this technology, we will conduct a series of prospective studies to investigate the&#xD;
      role of IR-Seq in the diagnosis and disease monitoring in patients with IgA nephropathy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2022</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>Urinary protein remission rate</measure>
    <time_frame>24 weeks</time_frame>
    <description>Including complete and partial remission rate of urinary protein. Complete remission criteria: post-treatment urine protein &lt;0.3 g/24h; partial remission criteria: post-treatment urine protein &lt;50% of the maximum value.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>24-hour urine protein level</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum albumin level</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>eGFR (estimated using the 2009 CKD-EPI formula)</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Anticipated">180</enrollment>
  <condition>IgA Nephropathy</condition>
  <arm_group>
    <arm_group_label>IgAN patients at low risk of disease progression</arm_group_label>
    <description>n = 30, incipient disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IgAN patients at high risk of disease progression</arm_group_label>
    <description>n = 60, incipient disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Long-term stable patients</arm_group_label>
    <description>n = 30, follow-up for at least 15 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Progressive IgAN patients</arm_group_label>
    <description>n = 30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
    <description>n = 30</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intervention for incipient patients at low risk of disease progression</intervention_name>
    <description>Conservative treatment, if necessary use ACEI/ARB and titrated to the maximum tolerated dose, with a BP-lowering goal of &lt; 130/80 mm Hg</description>
    <arm_group_label>IgAN patients at low risk of disease progression</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intervention for patients at high risk of disease progression</intervention_name>
    <description>BP-lowering goal of &lt; 125/75 mm Hg and treat with steroids or steroids combined with immunosuppressants based on optimal supportive therapy:&#xD;
If GFR&gt;60 ml/min/1.73m^2, oral prednisone 0.6-0.8 mg/kg/day ( (maximum dose 48 mg/day) for 2 months, followed by a monthly dose reduction of 8 mg for 24 weeks.&#xD;
If GFR is 30-60 ml/min/1.73m^2, intravenous cyclophosphamide (CTX) 750 mg per month per m^2 for 6 months, along with oral prednisone (at the same dose as 1); if intravenous administration is unacceptable, then the above regimen was replaced with oral mycophenolate mofetil 500 mg bid for 24 weeks.</description>
    <arm_group_label>IgAN patients at high risk of disease progression</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum samples; Blood samples taken using PAXgene vacuum blood collection tubes&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai&#xD;
        Jiao Tong University Affiliated Sixth People's Hospital, RenJi Hospital, Shanghai Zhongshan&#xD;
        Hospital, Longhua Hospital Shanghai University of Traditional Chinese Medicine and Shanghai&#xD;
        East Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. IgA nephropathy:&#xD;
&#xD;
          1. Age: 18-80 years.&#xD;
&#xD;
          2. Patients diagnosed with primary IgA nephropathy by renal biopsy.&#xD;
&#xD;
          3. Estimated glomerular filtration rate (using the 2009 CKD-EPI formula)&#xD;
             ≥30ml/min/1.73/m^2.&#xD;
&#xD;
          4. Obtain informed consent from patients. 2. Healthy Control: Gender, age and ethnicity&#xD;
             matched health volunteers. 3. IgAN patients were further divided into 4 groups, as&#xD;
             defined below:&#xD;
&#xD;
        1) Long-term stable patients:&#xD;
&#xD;
        Follow-up for at least 15 years and meet at least one of the following:&#xD;
&#xD;
          1. Annual eGFR loss rate &lt;3ml/min/1.73m^2.&#xD;
&#xD;
          2. eGFR&gt;90ml/min/1.73m^2. 2) Non-progressive IgAN patients:&#xD;
&#xD;
        Meet at least one of the following:&#xD;
&#xD;
          1. eGFR decrease of more than 50% from baseline (in the absence of other possible causes&#xD;
             of kidney damage).&#xD;
&#xD;
          2. Annual eGFR loss rate &gt;5ml/min/1.73m^2.&#xD;
&#xD;
          3. Progress to ESRD. 3) IgAN patients at low risk of disease progression: Proteinuria ≤&#xD;
             1g/24h after 3 months of optimized supportive care. 4) IgAN patients at high risk of&#xD;
             disease progression: Proteinuria &gt; 1g/24h despite 3 months of optimized supportive&#xD;
             care.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Kidney biopsy shows crescentic IgAN or MCD-IgAN.;&#xD;
&#xD;
          2. Patients with secondary IgAN;&#xD;
&#xD;
          3. During pregnancy or lactation;&#xD;
&#xD;
          4. After kidney transplantation;&#xD;
&#xD;
          5. More than one serious acute infection in the psat 12 months;&#xD;
&#xD;
          6. Chronic infection;&#xD;
&#xD;
          7. Use of glucocorticosteroids and other immunosuppressive drugs within the last 6&#xD;
             months;&#xD;
&#xD;
          8. Incomplete medical history or clinical data.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiang Gengru</last_name>
      <phone>+86-13917983703</phone>
      <email>jianggeng-ru@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>August 26, 2020</last_update_submitted>
  <last_update_submitted_qc>August 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IgA Nephropathy</keyword>
  <keyword>IR-Seq</keyword>
  <keyword>Biomarker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Glomerulonephritis, IGA</mesh_term>
  </condition_browse>
  <!-- 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/NCT04438603
org study id: XHEC-C-2020-070-1
nct id: NCT04438603
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This prospective study aims to investigate the role of IR-Seq in the diagnosis and disease
      monitoring in patients with IgA nephropathy.
Autoimmunity may play an important role in IgA nephropathy, and previous studies have shown
      that immune repertoire sequencing (IR-Seq) may help elucidate the dynamic changes of immune
      repertoire (IR) in autoimmune disease states. To further explore the potential application
      value of this technology, we will conduct a series of prospective studies to investigate the
      role of IR-Seq in the diagnosis and disease monitoring in patients with IgA nephropathy.
observational model: Cohort
time perspective: Prospective
measure: Urinary protein remission rate
time frame: 24 weeks
description: Including complete and partial remission rate of urinary protein. Complete remission criteria: post-treatment urine protein <0.3 g/24h; partial remission criteria: post-treatment urine protein <50% of the maximum value.
measure: 24-hour urine protein level
time frame: 24 weeks
measure: Serum albumin level
time frame: 24 weeks
measure: eGFR (estimated using the 2009 CKD-EPI formula)
time frame: 24 weeks
arm group label: IgAN patients at low risk of disease progression
description: n = 30, incipient disease
arm group label: IgAN patients at high risk of disease progression
description: n = 60, incipient disease
arm group label: Long-term stable patients
description: n = 30, follow-up for at least 15 years
arm group label: Progressive IgAN patients
description: n = 30
arm group label: Healthy control
description: n = 30
intervention type: Drug
intervention name: Intervention for incipient patients at low risk of disease progression
description: Conservative treatment, if necessary use ACEI/ARB and titrated to the maximum tolerated dose, with a BP-lowering goal of < 130/80 mm Hg
arm group label: IgAN patients at low risk of disease progression
intervention type: Drug
intervention name: Intervention for patients at high risk of disease progression
description: BP-lowering goal of < 125/75 mm Hg and treat with steroids or steroids combined with immunosuppressants based on optimal supportive therapy:
If GFR>60 ml/min/1.73m^2, oral prednisone 0.6-0.8 mg/kg/day ( (maximum dose 48 mg/day) for 2 months, followed by a monthly dose reduction of 8 mg for 24 weeks.
If GFR is 30-60 ml/min/1.73m^2, intravenous cyclophosphamide (CTX) 750 mg per month per m^2 for 6 months, along with oral prednisone (at the same dose as 1); if intravenous administration is unacceptable, then the above regimen was replaced with oral mycophenolate mofetil 500 mg bid for 24 weeks.
arm group label: IgAN patients at high risk of disease progression
Serum samples; Blood samples taken using PAXgene vacuum blood collection tubes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Glomerulonephritis, IGA