xml: <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/NCT06020534</url>
    </required_header>
    <id_info>
      <org_study_id>KT TASC</org_study_id>
      <nct_id>NCT06020534</nct_id>
    </id_info>
    <brief_title>Aortoiliac Stenosis in Kidney Transplantation</brief_title>
    <acronym>TASC</acronym>
    <official_title>Safety and Efficacy of Kidney Transplantation in Patients With Aortoiliac Stenosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Erasmus Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Erasmus Medical Center</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>
        The impact of aortoiliac stenosis on kidney transplant patients remains unclear. This study&#xD;
        aims to investigate the safety and efficacy of kidney transplantation in patients with&#xD;
        aortoiliac stenosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Kidney transplantation is the optimal treatment for end-stage renal disease (ESRD).&#xD;
        Unfortunately, not all ESRD patients are eligible for kidney transplantation. Aortoiliac&#xD;
        stenosis, an increasingly common type of peripheral arterial disease in ESRD patients, is&#xD;
        considered as relative contra-indication for kidney transplantation. There are several&#xD;
        reasons for concern, such as the complexity of the vascular anastomosis and inferior life&#xD;
        expectancy. Consequently, it is still debated whether patients with aortoiliac stenosis would&#xD;
        benefit from kidney transplantation.&#xD;
  &#xD;
        This study aimed to supplement current literature on the safety and efficacy of kidney&#xD;
        transplantation in patients with aortoiliac stenosis. To achieve this, all patients&#xD;
        undergoing kidney transplantation in Erasmus Medical Center between January 2010 and December&#xD;
        2020 were enrolled, and propensity score matching was used to minimize confounding factors.&#xD;
        Additionally, long-term graft function was investigated to evaluate the impact of stenosis on&#xD;
        graft function.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">January 31, 2023</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>patient survival</measure>
      <time_frame>From the date of kidney transplantation till death or January 2023.</time_frame>
      <description>All-cause death after kidney transplantation till the end of follow-up.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>death-censored graft survival</measure>
      <time_frame>From the date of kidney transplantation till death or January 2023.</time_frame>
      <description>Death-censored graft survival was defined as the time from transplant to graft failure, with censoring for death with a functioning graft.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Graft function</measure>
      <time_frame>From the date of kidney transplantation till death or January 2023.</time_frame>
      <description>Estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">655</enrollment>
    <condition>Aorto-Iliac Arterial Stenosis</condition>
    <condition>Peripheral Arterial Disease</condition>
    <condition>Kidney Transplant Failure</condition>
    <arm_group>
      <arm_group_label>No-stenosis group</arm_group_label>
      <description>Patients who had no pre-existing aortoiliac stenosis before kidney transplantation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TASC A/B stenosis</arm_group_label>
      <description>Patients who had TASC A or B aortoiliac stenosis before kidney transplantation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TASC C/D stenosis</arm_group_label>
      <description>Patients who had TASC C or D aortoiliac stenosis before kidney transplantation.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who underwent kidney transplantation in the Erasmus Medical Center between January&#xD;
          2010 and December 2020.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who underwent kidney transplantation in the Erasmus Medical Center between&#xD;
               January 2010 and December 2020&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who were under 18 years at transplantation&#xD;
  &#xD;
            -  Patients who underwent combined organ transplantation&#xD;
  &#xD;
            -  Patients who had no follow-up&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yitian Fang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Erasmus Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Yitian Fang</name>
        <address>
          <city>Rotterdam</city>
          <state>Zuid Holland</state>
          <zip>3015 GD</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
      <investigator_full_name>Yitian Fang, MD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>aortoiliac arterial stenosis</keyword>
    <keyword>peripheral arterial disease</keyword>
    <keyword>kidney transplantation</keyword>
    <keyword>outcomes</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peripheral Arterial Disease</mesh_term>
      <mesh_term>Peripheral Vascular Diseases</mesh_term>
      <mesh_term>Constriction, Pathologic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The data that support this study are not publicly available due to reasons of sensitivity and are available from the principal investigator upon reasonable request.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020534
  org study id: KT TASC
  nct id: NCT06020534
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The impact of aortoiliac stenosis on kidney transplant patients remains unclear. This study
        aims to investigate the safety and efficacy of kidney transplantation in patients with
        aortoiliac stenosis.
  Kidney transplantation is the optimal treatment for end-stage renal disease (ESRD).
        Unfortunately, not all ESRD patients are eligible for kidney transplantation. Aortoiliac
        stenosis, an increasingly common type of peripheral arterial disease in ESRD patients, is
        considered as relative contra-indication for kidney transplantation. There are several
        reasons for concern, such as the complexity of the vascular anastomosis and inferior life
        expectancy. Consequently, it is still debated whether patients with aortoiliac stenosis would
        benefit from kidney transplantation.
  
        This study aimed to supplement current literature on the safety and efficacy of kidney
        transplantation in patients with aortoiliac stenosis. To achieve this, all patients
        undergoing kidney transplantation in Erasmus Medical Center between January 2010 and December
        2020 were enrolled, and propensity score matching was used to minimize confounding factors.
        Additionally, long-term graft function was investigated to evaluate the impact of stenosis on
        graft function.
  observational model: Cohort
  time perspective: Retrospective
  measure: patient survival
  time frame: From the date of kidney transplantation till death or January 2023.
  description: All-cause death after kidney transplantation till the end of follow-up.
  measure: death-censored graft survival
  time frame: From the date of kidney transplantation till death or January 2023.
  description: Death-censored graft survival was defined as the time from transplant to graft failure, with censoring for death with a functioning graft.
  measure: Graft function
  time frame: From the date of kidney transplantation till death or January 2023.
  description: Estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
  arm group label: No-stenosis group
  description: Patients who had no pre-existing aortoiliac stenosis before kidney transplantation.
  arm group label: TASC A/B stenosis
  description: Patients who had TASC A or B aortoiliac stenosis before kidney transplantation.
  arm group label: TASC C/D stenosis
  description: Patients who had TASC C or D aortoiliac stenosis before kidney transplantation.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yitian Fang, MD
  role: Principal Investigator
  affiliation: Erasmus Medical Center
  facility: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Erasmus Medical Center
  investigator full name: Yitian Fang, MD
  investigator title: Principal Investigator
  mesh term: Peripheral Arterial Disease
  mesh term: Peripheral Vascular Diseases
  mesh term: Constriction, Pathologic
  sharing ipd: No
  ipd description: The data that support this study are not publicly available due to reasons of sensitivity and are available from the principal investigator upon reasonable request.