<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/NCT03227055</url>
  </required_header>
  <id_info>
    <org_study_id>201601181A3</org_study_id>
    <nct_id>NCT03227055</nct_id>
  </id_info>
  <brief_title>Cardiovascular Comorbidity in Children With Chronic Kidney Disease</brief_title>
  <official_title>Cardiovascular Comorbidity in Children With Chronic Kidney Disease: Identification of Novel Biomarkers and Therapeutic Targets</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</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>
      This 3-year study will systematically evaluate the prevalence, clinical symptoms, and&#xD;
      progression of CV and kidney disease and assess the impact of potential genetic,&#xD;
      pharmacological, behavior, and environmental risk factors in a prospective cohort with a&#xD;
      sample size of 125 aged 3-18 years children with stage G1-G4 chronic kidney disease (CKD).&#xD;
      Measurements of morphological (e.g., LVMI &amp; cIMT) and functional characteristics (e.g., FMD &amp;&#xD;
      PWV) of the cardiovascular system and 24hr ABPM profile will serve as surrogate end points&#xD;
      for CV comorbidity in this study. Possible associations of these end points with multiple&#xD;
      molecular (ADMA &amp; urine exosome miRNA), perceived value and behavior (EQ-5D-Y),&#xD;
      pharmacological (NHIRD and CGRD), and environmental risk factors (patient and family survey)&#xD;
      will be explored.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Taiwan has the highest incidence and prevalence rates of end-stage renal disease all over the&#xD;
      world. Chronic kidney disease (CKD) becomes a global public health burden, which can begin in&#xD;
      earliest childhood. CKD in childhood differs from that in adults. Congenital anomalies of the&#xD;
      kidney and urinary tract (CAKUT) is the leading cause of childhood CKD. Children with CKD due&#xD;
      to CAKUT have the highest risk of having a genomic imbalance. Thus, early identification of&#xD;
      genotype-phenotype correlations to develop novel therapeutic approaches might reduce the&#xD;
      heavy burden of CKD for the future of Taiwan.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
        1. A 3-year prospective cohort study.&#xD;
&#xD;
        2. Sample size: 125 children and adolescents with stage G1-G4 CKD, age 3 to 18 yr, and 30&#xD;
           controls.&#xD;
&#xD;
      4. Measurement: Measurements of morphological (e.g., LVMI &amp; cIMT) and functional&#xD;
      characteristics (e.g., FMD &amp; PWV) of the cardiovascular system and 24hr ABPM profile will&#xD;
      serve as surrogate end points for CV comorbidity in this study. Possible associations of&#xD;
      these end points with multiple molecular (ADMA &amp; urine exosome miRNA), perceived value and&#xD;
      behavior (EQ-5D-Y), pharmacological (NHIRD and CGRD), and environmental risk factors (patient&#xD;
      and family survey) will be explored.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 30, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>Hypertension</measure>
    <time_frame>1 year</time_frame>
    <description>Abnormal ABPM profile</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">155</enrollment>
  <condition>Childhood Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>CKD</arm_group_label>
    <description>Children and adolescents with stage G1-G4 CKD, age 3 to 18 yr</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma, urine, and stool&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        125 children and adolescents with stage G1-G4 CKD and 30 controls.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children and adolescents with stage G1-G4 CKD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current pregnancy&#xD;
&#xD;
          -  inability to complete major data collection&#xD;
&#xD;
          -  kidney transplant&#xD;
&#xD;
          -  cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>You-Lin Tain, MD, PhD</last_name>
    <phone>+886-7-7317123</phone>
    <phone_ext>8723</phone_ext>
    <email>tainyl@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chien-Ning Hsu, PhD</last_name>
    <phone>+886-7-7317123</phone>
    <phone_ext>6131</phone_ext>
    <email>chien_ning_hsu@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>You-Lin Tain, MD, PhD</last_name>
      <email>tainyl@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Tain, You-Lin</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Arterial stiffness, children, chronic kidney disease, hypertension, microRNA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03227055
org study id: 201601181A3
nct id: NCT03227055
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This 3-year study will systematically evaluate the prevalence, clinical symptoms, and
      progression of CV and kidney disease and assess the impact of potential genetic,
      pharmacological, behavior, and environmental risk factors in a prospective cohort with a
      sample size of 125 aged 3-18 years children with stage G1-G4 chronic kidney disease (CKD).
      Measurements of morphological (e.g., LVMI & cIMT) and functional characteristics (e.g., FMD &
      PWV) of the cardiovascular system and 24hr ABPM profile will serve as surrogate end points
      for CV comorbidity in this study. Possible associations of these end points with multiple
      molecular (ADMA & urine exosome miRNA), perceived value and behavior (EQ-5D-Y),
      pharmacological (NHIRD and CGRD), and environmental risk factors (patient and family survey)
      will be explored.
Taiwan has the highest incidence and prevalence rates of end-stage renal disease all over the
      world. Chronic kidney disease (CKD) becomes a global public health burden, which can begin in
      earliest childhood. CKD in childhood differs from that in adults. Congenital anomalies of the
      kidney and urinary tract (CAKUT) is the leading cause of childhood CKD. Children with CKD due
      to CAKUT have the highest risk of having a genomic imbalance. Thus, early identification of
      genotype-phenotype correlations to develop novel therapeutic approaches might reduce the
      heavy burden of CKD for the future of Taiwan.

      Study design:

        1. A 3-year prospective cohort study.

        2. Sample size: 125 children and adolescents with stage G1-G4 CKD, age 3 to 18 yr, and 30
           controls.

      4. Measurement: Measurements of morphological (e.g., LVMI & cIMT) and functional
      characteristics (e.g., FMD & PWV) of the cardiovascular system and 24hr ABPM profile will
      serve as surrogate end points for CV comorbidity in this study. Possible associations of
      these end points with multiple molecular (ADMA & urine exosome miRNA), perceived value and
      behavior (EQ-5D-Y), pharmacological (NHIRD and CGRD), and environmental risk factors (patient
      and family survey) will be explored.
observational model: Cohort
time perspective: Prospective
measure: Hypertension
time frame: 1 year
description: Abnormal ABPM profile
arm group label: CKD
description: Children and adolescents with stage G1-G4 CKD, age 3 to 18 yr
Plasma, urine, and stool
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: You-Lin Tain, MD, PhD
phone: +886-7-7317123
phone ext: 8723
email: tainyl@hotmail.com
last name: Chien-Ning Hsu, PhD
phone: +886-7-7317123
phone ext: 6131
email: chien_ning_hsu@hotmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Tain, You-Lin
investigator title: Professor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: No