<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/NCT02972346</url>
  </required_header>
  <id_info>
    <org_study_id>XH-16-044</org_study_id>
    <nct_id>NCT02972346</nct_id>
  </id_info>
  <brief_title>Availability Study of ACTH to Treat Children SRNS/SDNS</brief_title>
  <official_title>Availability and Safety Study of ACTH to Treat Children SRNS/SDNS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary nephrotic syndrome(NS) is a common children renal disease.About 20% primary nephrotic&#xD;
      syndrome are steroid-dependent and steroid-resistant.Low serum cortisol is one of the main&#xD;
      relapse reasons.Adrenocorticotropic hormone(ACTH)-induced steroidogenesis improve serum&#xD;
      cortisol and also direct melanocortin receptors(MCRs) mediated protective effect on kidney&#xD;
      cells. To investigate the efficacy and safety of ACTH to treat NS, total 42 children steroid&#xD;
      resistant or steroid dependent NS is enrolling in this multicenter, prospective case series&#xD;
      of prescription based treatment with ACTH for NS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary nephrotic syndrome(NS) is a common children renal disease.About 20% primary nephrotic&#xD;
      syndrome are steroid-dependent and steroid-resistant.Low serum cortisol is one of the main&#xD;
      relapse reasons.Adrenocorticotropic hormone(ACTH) can stimulates the adrenal cortex and its&#xD;
      production of corticosteroids.ACTH also direct melanocortin receptors(MCRs) mediated&#xD;
      protective effect on kidney cells. To investigate the efficacy and safety of ACTH to treat&#xD;
      NS, total 42 children steroid resistant or steroid dependent NS is enrolling in this&#xD;
      multicenter, prospective case series of prescription based treatment with ACTH for NS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>N/A</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>24-hour proteinuria excretion</measure>
    <time_frame>1.5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>times of relapse</measure>
    <time_frame>1.5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Proteinuria</condition>
  <arm_group>
    <arm_group_label>ACTH(+)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>routine treatment + ACTH</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACTH(-)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>routine treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACTH</intervention_name>
    <description>routine treatment plus ACTH 0.4 Unit/kg/day (Maximum 25Unit) for three consecutive days every 4 weeks</description>
    <arm_group_label>ACTH(+)</arm_group_label>
    <other_name>adrenocorticotropic hormone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age:3-12 years old&#xD;
&#xD;
          2. primary nephrotic syndrome&#xD;
&#xD;
          3. SRNS or SDNS&#xD;
&#xD;
          4. Minor lesion or minimal change disease&#xD;
&#xD;
          5. Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Second nephrotic syndrome&#xD;
&#xD;
          2. allergic to ACTH&#xD;
&#xD;
          3. Refuse to signed informed consent&#xD;
&#xD;
          4. have had ACTH treatment&#xD;
&#xD;
          5. serious complication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yufeng Li, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yufeng Li, Ph.D.</last_name>
    <phone>136517220156</phone>
    <email>mieuniversity@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yaju Zhu, MD</last_name>
    <phone>136501664385</phone>
    <email>yayastime@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xinhua Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Beiqing Jiang</last_name>
      <phone>86-21-25078999</phone>
      <email>Xinhuakeyan@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 20, 2016</last_update_submitted>
  <last_update_submitted_qc>November 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</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>Proteinuria</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adrenocorticotropic Hormone</mesh_term>
    <mesh_term>Melanocyte-Stimulating Hormones</mesh_term>
    <mesh_term>beta-Endorphin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT02972346
org study id: XH-16-044
nct id: NCT02972346
lead sponsor: 
has dmc: No
Primary nephrotic syndrome(NS) is a common children renal disease.About 20% primary nephrotic
      syndrome are steroid-dependent and steroid-resistant.Low serum cortisol is one of the main
      relapse reasons.Adrenocorticotropic hormone(ACTH)-induced steroidogenesis improve serum
      cortisol and also direct melanocortin receptors(MCRs) mediated protective effect on kidney
      cells. To investigate the efficacy and safety of ACTH to treat NS, total 42 children steroid
      resistant or steroid dependent NS is enrolling in this multicenter, prospective case series
      of prescription based treatment with ACTH for NS.
Primary nephrotic syndrome(NS) is a common children renal disease.About 20% primary nephrotic
      syndrome are steroid-dependent and steroid-resistant.Low serum cortisol is one of the main
      relapse reasons.Adrenocorticotropic hormone(ACTH) can stimulates the adrenal cortex and its
      production of corticosteroids.ACTH also direct melanocortin receptors(MCRs) mediated
      protective effect on kidney cells. To investigate the efficacy and safety of ACTH to treat
      NS, total 42 children steroid resistant or steroid dependent NS is enrolling in this
      multicenter, prospective case series of prescription based treatment with ACTH for NS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 24-hour proteinuria excretion
time frame: 1.5 years
measure: times of relapse
time frame: 1.5 years
arm group label: ACTH(+)
arm group type: Experimental
description: routine treatment + ACTH
arm group label: ACTH(-)
arm group type: No Intervention
description: routine treatment
intervention type: Drug
intervention name: ACTH
description: routine treatment plus ACTH 0.4 Unit/kg/day (Maximum 25Unit) for three consecutive days every 4 weeks
arm group label: ACTH(+)
other name: adrenocorticotropic hormone
criteria: 
gender: All
minimum age: 3 Years
maximum age: 12 Years
healthy volunteers: No
last name: Yufeng Li, Ph.D.
role: Study Director
affiliation: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
last name: Yufeng Li, Ph.D.
phone: 136517220156
email: mieuniversity@hotmail.com
last name: Yaju Zhu, MD
phone: 136501664385
email: yayastime@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Proteinuria
mesh term: Adrenocorticotropic Hormone
mesh term: Melanocyte-Stimulating Hormones
mesh term: beta-Endorphin
sharing ipd: Yes