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/NCT05977387</url>
    </required_header>
    <id_info>
      <org_study_id>HJ-21-PeKiT</org_study_id>
      <nct_id>NCT05977387</nct_id>
    </id_info>
    <brief_title>Pediatric Kidney Transplant</brief_title>
    <acronym>PeKiT</acronym>
    <official_title>Pediatric Kidney Transplant</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Imagine Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Imagine Institute</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>
        End-stage renal disease (ESRD) is a rare disease in children. Renal transplantation (RT) is&#xD;
        the treatment of choice for ESRD in the pediatric population. In France, around 100 pediatric&#xD;
        kidney transplants are performed each year. The aim was to evaluate the surgical management&#xD;
        of TR and the long-term results.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        End-stage renal disease (ESRD) is a rare pathology in children, whose gold standard treatment&#xD;
        is a kidney transplant. In France, around 100 pediatric kidney transplants are performed&#xD;
        every year.&#xD;
  &#xD;
        Although the first adult kidney transplants were performed in 1954, pediatric renal&#xD;
        transplantation was considered unsafe compared with dialysis, which was preferred. In the&#xD;
        1980s, improved graft selection, optimized pre-transplant management and a better&#xD;
        understanding of the immune system led to the development of pediatric kidney&#xD;
        transplantation.&#xD;
  &#xD;
        Despite considerable progress, graft survival in these long-lived patients remains a major&#xD;
        challenge.&#xD;
  &#xD;
        The aim of this study is to evaluate surgical practices in the four French pediatric&#xD;
        transplant centers, and to define risk factors for surgical complications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 1, 2021</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</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>Surgical outcomes</measure>
      <time_frame>10 years</time_frame>
      <description>To assess surgical outcome in pediatric renal transplantation in terms of&#xD;
  per operative complications (ClassIntra classification)&#xD;
  post operative complications (Clavien Dindo) early &lt; 30 days and late &gt; 30 days</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Surgical complications</measure>
      <time_frame>10 years</time_frame>
      <description>Evaluate the surgical morbidity of renal transplantation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Graft Survival</measure>
      <time_frame>10 years</time_frame>
      <description>Evaluate graft survival at 1, 5 and 10 years post transplantation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Return to dialysis</measure>
      <time_frame>10 years</time_frame>
      <description>Evaluation of the need to return to dialysis after transplantation : causes and reasons</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Retransplantation</measure>
      <time_frame>10 years</time_frame>
      <description>Evaluation the number of patient undegoing another transplantation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Death</measure>
      <time_frame>10 years</time_frame>
      <description>Evaluation of the morbidity of this population</description>
    </secondary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>End Stage Renal Disease</condition>
    <condition>Pediatric ALL</condition>
    <condition>Kidney Transplant; Complications</condition>
    <eligibility>
      <study_pop>
        <textblock>
          All patients from 0 to 18 years who underwent renal transplant for ESRD&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All pediatric patients who underwent renal transplantation in one of the 4 centers&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Multi organ transplant&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Thomas Blanc, Pr</last_name>
      <phone>+ 33 1 44 49 41 86</phone>
      <email>thomas.blanc@aphp.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>l'hôpital mère-enfant de Lyon</name>
        <address>
          <city>Bron</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Thomas Blanc, Pr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>l'hôpital mère enfant de Nantes</name>
        <address>
          <city>Nantes</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Thomas Leblanc, Pr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>l'hôpital Robert Debré</name>
        <address>
          <city>Paris</city>
          <zip>75019</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Thomas Blanc, Pr</last_name>
        <phone>+ 33 1 44 49 41 86</phone>
        <email>thomas.blanc@aphp.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>l'hôpital Necker Enfants malades.</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Thomas Blanc, Pr</last_name>
        <phone>+ 33 1 44 49 41 86</phone>
        <email>thomas.blanc@aphp.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 8, 2022</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</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>Kidney Failure, Chronic</mesh_term>
    </condition_browse>
    <!-- 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/NCT05977387
  org study id: HJ-21-PeKiT
  nct id: NCT05977387
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  End-stage renal disease (ESRD) is a rare disease in children. Renal transplantation (RT) is
        the treatment of choice for ESRD in the pediatric population. In France, around 100 pediatric
        kidney transplants are performed each year. The aim was to evaluate the surgical management
        of TR and the long-term results.
  End-stage renal disease (ESRD) is a rare pathology in children, whose gold standard treatment
        is a kidney transplant. In France, around 100 pediatric kidney transplants are performed
        every year.
  
        Although the first adult kidney transplants were performed in 1954, pediatric renal
        transplantation was considered unsafe compared with dialysis, which was preferred. In the
        1980s, improved graft selection, optimized pre-transplant management and a better
        understanding of the immune system led to the development of pediatric kidney
        transplantation.
  
        Despite considerable progress, graft survival in these long-lived patients remains a major
        challenge.
  
        The aim of this study is to evaluate surgical practices in the four French pediatric
        transplant centers, and to define risk factors for surgical complications.
  observational model: Cohort
  time perspective: Retrospective
  measure: Surgical outcomes
  time frame: 10 years
  description: To assess surgical outcome in pediatric renal transplantation in terms of
  per operative complications (ClassIntra classification)
  post operative complications (Clavien Dindo) early < 30 days and late > 30 days
  measure: Surgical complications
  time frame: 10 years
  description: Evaluate the surgical morbidity of renal transplantation
  measure: Graft Survival
  time frame: 10 years
  description: Evaluate graft survival at 1, 5 and 10 years post transplantation
  measure: Return to dialysis
  time frame: 10 years
  description: Evaluation of the need to return to dialysis after transplantation : causes and reasons
  measure: Retransplantation
  time frame: 10 years
  description: Evaluation the number of patient undegoing another transplantation
  measure: Death
  time frame: 10 years
  description: Evaluation of the morbidity of this population
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 0 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Thomas Blanc, Pr
  phone: + 33 1 44 49 41 86
  email: thomas.blanc@aphp.fr
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Kidney Failure, Chronic