<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/NCT01686191</url>
  </required_header>
  <id_info>
    <org_study_id>12-0869</org_study_id>
    <secondary_id>12GRNT12040211</secondary_id>
    <secondary_id>UL1TR002535</secondary_id>
    <secondary_id>TL1TR002533</secondary_id>
    <nct_id>NCT01686191</nct_id>
  </id_info>
  <brief_title>Genetic Predictors of Renal Dysfunction Following Heart Transplantation</brief_title>
  <official_title>Pharmacogenomics of Calcineurin Inhibitor Nephrotoxicity in Cardiac Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Jewish Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Kidney disease is a common problem after heart transplantation. It may be caused by&#xD;
      anti-rejection medications such as cyclosporine or tacrolimus. However, the reason why some&#xD;
      people develop kidney problems after a heart transplant, but other people do not, is not&#xD;
      fully known. This study plans to learn more about the relationship between a person's genetic&#xD;
      make-up (DNA; deoxyribonucleic acid) and the risk of kidney problems after a heart&#xD;
      transplant. The long-term goal of this research is to identify genetic variations that may&#xD;
      help predict the development of kidney problems after heart transplantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Chronic renal dysfunction</measure>
    <time_frame>year 2 post-transplant</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Heart Transplantation</condition>
  <condition>Chronic Renal Insufficiency</condition>
  <arm_group>
    <arm_group_label>Cardiac transplant recipients</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Buccal cell and blood sample for genomic DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Cardiac transplant clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cardiac-only transplant&#xD;
&#xD;
          -  18 years of age or older at the time of cardiac transplant&#xD;
&#xD;
          -  1 year or more post-cardiac transplant&#xD;
&#xD;
          -  treatment with cyclosporine or tacrolimus following transplant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  combined organ transplant&#xD;
&#xD;
          -  decisionally impaired&#xD;
&#xD;
          -  unable to read or speak English&#xD;
&#xD;
          -  unable or unwilling to provide written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina L Aquilante, Pharm.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2012</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heart transplantation</keyword>
  <keyword>chronic renal insufficiency</keyword>
  <keyword>pharmacogenomics</keyword>
  <keyword>cyclosporine</keyword>
  <keyword>tacrolimus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</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/NCT01686191
org study id: 12-0869
secondary id: 12GRNT12040211
secondary id: UL1TR002535
secondary id: TL1TR002533
nct id: NCT01686191
lead sponsor: 
collaborator: 
has dmc: No
Kidney disease is a common problem after heart transplantation. It may be caused by
      anti-rejection medications such as cyclosporine or tacrolimus. However, the reason why some
      people develop kidney problems after a heart transplant, but other people do not, is not
      fully known. This study plans to learn more about the relationship between a person's genetic
      make-up (DNA; deoxyribonucleic acid) and the risk of kidney problems after a heart
      transplant. The long-term goal of this research is to identify genetic variations that may
      help predict the development of kidney problems after heart transplantation.
observational model: Cohort
time perspective: Retrospective
measure: Chronic renal dysfunction
time frame: year 2 post-transplant
arm group label: Cardiac transplant recipients
Buccal cell and blood sample for genomic DNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Christina L Aquilante, Pharm.D.
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Renal Insufficiency, Chronic