<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/NCT03786263</url>
  </required_header>
  <id_info>
    <org_study_id>REB13-0059</org_study_id>
    <nct_id>NCT03786263</nct_id>
  </id_info>
  <brief_title>CHILDNEPH The Canadian Childhood Nephrotic Syndrome Study</brief_title>
  <acronym>CHILDNEPH</acronym>
  <official_title>The Canadian Childhood Nephrotic Syndrome (CHILDNEPH) Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      CHILDNEPH is a pan-Canadian project to observe clinical care for children with nephrotic&#xD;
      syndrome. Previous studies have indicated that there is wide practice variation in how health&#xD;
      care providers treat this remitting and relapsing disease of childhood. The disease mechanism&#xD;
      is not yet understood, and long-term use of steroids can affect children's health. This study&#xD;
      involves assessment of routine clinical care and establishing a long-term patient registry&#xD;
      for children with nephrotic syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CHILDNEPH is an ongoing prospective longitudinal study of children with incident and&#xD;
      prevalent nephrotic syndrome. Children are recruited from 12 centres across Canada and&#xD;
      followed for at least 30 months. The project starting in August of 2013 with the goal of&#xD;
      following 400 patients. Data is collected at enrollment, beginning and end of each relapse,&#xD;
      semi-annual visits and end of study. Detailed prescription data is collected regarding&#xD;
      glucocorticoids and all second line agents. All relapses are recorded with time to urinary&#xD;
      remission of proteinuria.&#xD;
&#xD;
      The investigators are moving towards registry based trials to determine optimal treatment&#xD;
      protocols for nephrotic syndrome with an overall goal to minimize glucocorticoid exposure, a&#xD;
      patient priority.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 3, 2014</start_date>
  <completion_date type="Anticipated">March 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>30 Months</target_duration>
  <primary_outcome>
    <measure>Association of steroid dose prescribed with relapse rates</measure>
    <time_frame>30 months up to 90 months</time_frame>
    <description>Total steroid dose prescribed per unit time is determined by the total dose patients are prescribed during observation divided by total number of days on treatment. Dose will always be in mg/m2 prednisone equivalents. The relapse rate is the number of relapses/per person unit time.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Nephrotic Syndrome in Children</condition>
  <condition>Nephrotic Syndrome, Minimal Change</condition>
  <condition>Nephrotic Syndrome，Idiopathic</condition>
  <arm_group>
    <arm_group_label>Prospective Treatments for NS</arm_group_label>
    <description>Observation of children (between the ages of 1 and 17) who are diagnosed with Nephrotic Syndrome at their initial presentation, first or second relapse.&#xD;
Observation of children who receive Glucocorticoids to treat Nephrotic Syndrome.&#xD;
Observation of children who receive other drugs (Second Line Agents) for Nephrotic Syndrome.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Children (ages 1 to 17 years) who are diagnosed with Nephrotic Syndrome (minimal change&#xD;
        disease or idiopathic NS) who present at a participating pediatric nephrology clinic in&#xD;
        Canada.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis with Nephrotic Sydrome at initial presentation, first or second relapse&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to participate in English or French&#xD;
&#xD;
          -  Nephrotic Syndrome is secondary to other disease&#xD;
&#xD;
          -  Younger than one year old or older than 17 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Samuel, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laurel Ryan, MFA</last_name>
    <phone>403-955-7160</phone>
    <email>laurel.ryan@ahs.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maneka Perinpanayagam, PhD</last_name>
    <phone>403-955-2467</phone>
    <email>maneka.perinpanayagam@ahs.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Alberta Children's Hospital</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3B 6A8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurel Ryan, MFA</last_name>
      <phone>403-955-7160</phone>
      <email>laurel.ryan@ahs.ca</email>
    </contact>
    <contact_backup>
      <last_name>Maneka Perinpanayagam, PhD</last_name>
      <phone>403-955-2467</phone>
      <email>maneka.perinpanayagam@ahs.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Susan Samuel, MD MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Silviu Grisaru, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrew Wade, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Stollery Children's Hospital, University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine Morgan, MD</last_name>
      <email>cmorgan@ualberta.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>British Columbia Children's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cherry Mammen, MD</last_name>
      <phone>604-875-2345</phone>
      <phone_ext>7254</phone_ext>
      <email>cmammen@cw.bc.ca</email>
    </contact>
    <contact_backup>
      <last_name>Allison Eddy, MD</last_name>
      <phone>604-875-2345</phone>
      <phone_ext>7254</phone_ext>
      <email>allison.eddy@cw.bc.ca</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Winnipeg Children's Hospital, University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A 1S1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Allison Dart, MD</last_name>
      <email>adart@hsc.mb.ca</email>
    </contact>
    <contact_backup>
      <last_name>Maury Pinsk, MD</last_name>
      <email>mpinsk@hsc.mb.ca</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>IWK Health Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Tee, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>McMaster Children's Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 3Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Steve Arora, MD</last_name>
      <email>arorast@mcmaster.ca</email>
    </contact>
    <contact_backup>
      <last_name>Rahul Chanchlani, MD</last_name>
      <email>chanchlr@mcmaster.ca</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Children's Hospital, London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guido Filler, MD</last_name>
      <email>guido.filler@lhsc.on.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Eastern Ontario (CHEO) University of Ottawa</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pavel Geier, MD</last_name>
      <email>pgeier@cheo.on.ca</email>
    </contact>
    <contact_backup>
      <last_name>Janusz Feber, MD</last_name>
      <email>jfeber@cheo.on.ca</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children (SickKids)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rulan Parekh, MD</last_name>
      <email>rulan.parekh@sickkids.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Ste. Justine</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>B3H 1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Genevieve Benoit, MD</last_name>
      <phone>514-345-4931</phone>
      <phone_ext>7729</phone_ext>
      <email>genevieve.benoit.hsj@ssss.gouv.qc.ca</email>
    </contact>
    <contact_backup>
      <last_name>Anne-Laure Lapeyraque, MD</last_name>
      <phone>514-345-4931</phone>
      <phone_ext>7729</phone_ext>
      <email>anne-laure.lapeyraque.hsj@ssss.gouv.qc.ca</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Montreal Children's Hospital - McGill University</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Beth Foster, MD</last_name>
      <email>beth.foster@muhc.mcgill.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal University Hospital, University of Saskatchewan</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 0W8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robin Erickson, MD</last_name>
      <email>robin.erickson@usask.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>June 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>May 2, 2019</last_update_submitted>
  <last_update_submitted_qc>May 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2019</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>Nephrotic Syndrome</mesh_term>
    <mesh_term>Nephrosis</mesh_term>
    <mesh_term>Nephrosis, Lipoid</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 25, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03786263/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03786263
org study id: REB13-0059
nct id: NCT03786263
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
CHILDNEPH is a pan-Canadian project to observe clinical care for children with nephrotic
      syndrome. Previous studies have indicated that there is wide practice variation in how health
      care providers treat this remitting and relapsing disease of childhood. The disease mechanism
      is not yet understood, and long-term use of steroids can affect children's health. This study
      involves assessment of routine clinical care and establishing a long-term patient registry
      for children with nephrotic syndrome.
CHILDNEPH is an ongoing prospective longitudinal study of children with incident and
      prevalent nephrotic syndrome. Children are recruited from 12 centres across Canada and
      followed for at least 30 months. The project starting in August of 2013 with the goal of
      following 400 patients. Data is collected at enrollment, beginning and end of each relapse,
      semi-annual visits and end of study. Detailed prescription data is collected regarding
      glucocorticoids and all second line agents. All relapses are recorded with time to urinary
      remission of proteinuria.

      The investigators are moving towards registry based trials to determine optimal treatment
      protocols for nephrotic syndrome with an overall goal to minimize glucocorticoid exposure, a
      patient priority.
observational model: Cohort
time perspective: Prospective
measure: Association of steroid dose prescribed with relapse rates
time frame: 30 months up to 90 months
description: Total steroid dose prescribed per unit time is determined by the total dose patients are prescribed during observation divided by total number of days on treatment. Dose will always be in mg/m2 prednisone equivalents. The relapse rate is the number of relapses/per person unit time.
arm group label: Prospective Treatments for NS
description: Observation of children (between the ages of 1 and 17) who are diagnosed with Nephrotic Syndrome at their initial presentation, first or second relapse.
Observation of children who receive Glucocorticoids to treat Nephrotic Syndrome.
Observation of children who receive other drugs (Second Line Agents) for Nephrotic Syndrome.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 17 Years
healthy volunteers: No
last name: Susan Samuel, MD, MSc
role: Principal Investigator
affiliation: University of Calgary
last name: Laurel Ryan, MFA
phone: 403-955-7160
email: laurel.ryan@ahs.ca
last name: Maneka Perinpanayagam, PhD
phone: 403-955-2467
email: maneka.perinpanayagam@ahs.ca
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
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status: Recruiting
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facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
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status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
mesh term: Nephrotic Syndrome
mesh term: Nephrosis
mesh term: Nephrosis, Lipoid
mesh term: Syndrome
sharing ipd: Undecided
provided document: 