<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/NCT02239016</url>
  </required_header>
  <id_info>
    <org_study_id>2009-0026</org_study_id>
    <nct_id>NCT02239016</nct_id>
  </id_info>
  <brief_title>Screening Patients With Sickle Cell Disease for Kidney Damage</brief_title>
  <official_title>Screening Patients With Sickle Cell Disease for Kidney Damage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to study the temporal course of sickle nephropathy and assess novel&#xD;
      biomarkers that can predict patients prone to nephropathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sickle cell disease causes kidney damage that gets worse with increasing age, leading to&#xD;
      chronic kidney disease and kidney failure in nearly one third of patients with sickle cell&#xD;
      disease. Some patients develop kidney damage at a young age and others show mild kidney&#xD;
      damage at older ages. We do not know the natural progression of kidney damage in sickle cell&#xD;
      disease patients, nor do we know who is more prone to develop severe kidney damage.&#xD;
      Therefore, currently, there are no preventative measures or treatments for sickle cell&#xD;
      related kidney disease. The purpose of this research study is to collect data that will help&#xD;
      in assessing the progression of kidney damage in sickle cell disease, develop novel urine and&#xD;
      blood tests that can predict kidney damage early, and developing treatment ideas for&#xD;
      intervention and prevention of kidney damage that eventually leads to kidney failure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2009</start_date>
  <completion_date type="Actual">July 29, 2020</completion_date>
  <primary_completion_date type="Actual">July 29, 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>Rate of progression of microalbuminuria.</measure>
    <time_frame>Baseline through 36 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of novel urinary biomarkers.</measure>
    <time_frame>baseline, year 1, year 2 and year 3</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">320</enrollment>
  <condition>Sickle Cell Disease</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine, whole blood and serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Sickle cell clinics at various universities and hospitals.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sickle cell disease (i.e. Hgb SS, Hgb SC, Sβ-Thalassemia)&#xD;
&#xD;
          -  Individuals at baseline/steady state (absence of fever or acute sickle event, defined&#xD;
             as vaso-occlusive pain crises, acute chest syndrome, splenic sequestration, stroke,&#xD;
             priapism) for three weeks.&#xD;
&#xD;
          -  Adult Subjects &gt; 18 years of age: ability to consent to donate blood and/or urine for&#xD;
             research purposes only.&#xD;
&#xD;
          -  Newborn to &lt; 18 years of age: ability of parent/legal guardian to consent for&#xD;
             peripheral blood and/or urine samples to be obtained for research purposes only.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hematologic malignancy&#xD;
&#xD;
          -  Patients that either do not have the ability to undergo the informed consent process&#xD;
             or whose parent/legal guardian does not have the ability to undergo the informed&#xD;
             consent process&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Punam Malik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University (Children's Healthcare of Atlanta Pediatric Hospital)</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univeristy of Louisville (Kosair Children's Hospital)</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akron Childen's Hospital</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Sundaram N, Bennett M, Wilhelm J, Kim MO, Atweh G, Devarajan P, Malik P. Biomarkers for early detection of sickle nephropathy. Am J Hematol. 2011 Jul;86(7):559-66. doi: 10.1002/ajh.22045. Epub 2011 May 31.</citation>
    <PMID>21630304</PMID>
  </results_reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>March 26, 2021</last_update_submitted>
  <last_update_submitted_qc>March 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sickle cell disease</keyword>
  <keyword>Hgb SS</keyword>
  <keyword>Hgb SC</keyword>
  <keyword>Sβ-Thalassemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</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/NCT02239016
org study id: 2009-0026
nct id: NCT02239016
lead sponsor: 
has dmc: No
This study aims to study the temporal course of sickle nephropathy and assess novel
      biomarkers that can predict patients prone to nephropathy.
Sickle cell disease causes kidney damage that gets worse with increasing age, leading to
      chronic kidney disease and kidney failure in nearly one third of patients with sickle cell
      disease. Some patients develop kidney damage at a young age and others show mild kidney
      damage at older ages. We do not know the natural progression of kidney damage in sickle cell
      disease patients, nor do we know who is more prone to develop severe kidney damage.
      Therefore, currently, there are no preventative measures or treatments for sickle cell
      related kidney disease. The purpose of this research study is to collect data that will help
      in assessing the progression of kidney damage in sickle cell disease, develop novel urine and
      blood tests that can predict kidney damage early, and developing treatment ideas for
      intervention and prevention of kidney damage that eventually leads to kidney failure.
observational model: Cohort
time perspective: Prospective
measure: Rate of progression of microalbuminuria.
time frame: Baseline through 36 months
measure: Evaluation of novel urinary biomarkers.
time frame: baseline, year 1, year 2 and year 3
Urine, whole blood and serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Punam Malik, MD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Sundaram N, Bennett M, Wilhelm J, Kim MO, Atweh G, Devarajan P, Malik P. Biomarkers for early detection of sickle nephropathy. Am J Hematol. 2011 Jul;86(7):559-66. doi: 10.1002/ajh.22045. Epub 2011 May 31.
PMID: 21630304
responsible party type: Sponsor
mesh term: Anemia, Sickle Cell