<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/NCT03024229</url>
  </required_header>
  <id_info>
    <org_study_id>PHAO15/FB-RENALIFE</org_study_id>
    <nct_id>NCT03024229</nct_id>
  </id_info>
  <brief_title>Metabolomics in Assessing the Quality of Kidney Transplants Retained on a LifePort® Perfusion Machine</brief_title>
  <acronym>RENALIFE</acronym>
  <official_title>The Importance of Metabolomics in Assessing the Quality of Kidney Transplants Retained on a LifePort® Perfusion Machine Before Renal Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laboratory of Biochemistry, University François Rabelais of TOURS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Tours</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>
      When the kidneys are perfused on perfusion machines before transplantation, the resistance&#xD;
      parameters as well as the histological score on the pre-implantation biopsy participate in&#xD;
      the evaluation of the quality of the graft. The metabolomic profile of the infusion fluid&#xD;
      could provide additional evidence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The quality of the renal transplant prior to transplantation is essential for the recovery of&#xD;
      graft function in the days following transplantation and its long-term survival. When the&#xD;
      kidneys are perfused on perfusion machines before transplantation, the resistance parameters&#xD;
      as well as the histological score on the pre-implantation biopsy participate in the&#xD;
      evaluation of the quality of the graft. The metabolomic profile of the infusion fluid could&#xD;
      provide additional evidence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2017</start_date>
  <completion_date type="Actual">January 14, 2020</completion_date>
  <primary_completion_date type="Actual">September 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Metabolic assessment in Urine and perfusion liquids</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IGF</measure>
    <time_frame>7 days</time_frame>
    <description>Immediate Graft Function (IGF), defined by serum creatinine less than 250 μM / L at day 7 post-kidney transplant, without requiring dialysis of the recipient patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DGF</measure>
    <time_frame>7 days</time_frame>
    <description>DGF Delayed graft function : Dialysis need within 7 days post-transplant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BANFF-1</measure>
    <time_frame>PRE-OPERATIONAL</time_frame>
    <description>Anatomo-pathological classification of the pre-implantation biopsy according to the revised Banff classification 2013</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BANFF-2</measure>
    <time_frame>3 months</time_frame>
    <description>Anatomo-pathological classification of systematic biopsy at 3 months post-transplant according to the revised Banff classification 2013</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Renal Transplantation</condition>
  <arm_group>
    <arm_group_label>LifePort® perfusion machine</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Metabolomic analysis of the preservation fluid of the graft, donor and recipient urine by nuclear magnetic resonance spectroscopy, and if possible by liquid and gas chromatography coupled with mass spectrometry.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LifePort® perfusion machine</intervention_name>
    <description>Renal perfusion on LifePort® machine</description>
    <arm_group_label>LifePort® perfusion machine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Donors aged 18 years or more in brain death or who died of cardiac arrest collected&#xD;
             locally in Tours, associated with the major local recipients of the grafts over the&#xD;
             same period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Kidney transplant removed but stored in a static preservative.&#xD;
&#xD;
          -  Kidney grafts of donors aged 18 years or more, removed and not retained on a LifePort®&#xD;
             perfusion machine.&#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>Franck BRUYERE, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University François Rabelais of TOURS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Urology CHRU-TOURS</name>
      <address>
        <city>Tours</city>
        <state>I&amp;L</state>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR-ORLEANS Service d'Urologie</name>
      <address>
        <city>Orléans</city>
        <state>Loiret</state>
        <zip>45100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>September 3, 2020</last_update_submitted>
  <last_update_submitted_qc>September 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transplantation;perfusion machine</keyword>
  <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/NCT03024229
org study id: PHAO15/FB-RENALIFE
nct id: NCT03024229
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
When the kidneys are perfused on perfusion machines before transplantation, the resistance
      parameters as well as the histological score on the pre-implantation biopsy participate in
      the evaluation of the quality of the graft. The metabolomic profile of the infusion fluid
      could provide additional evidence.
The quality of the renal transplant prior to transplantation is essential for the recovery of
      graft function in the days following transplantation and its long-term survival. When the
      kidneys are perfused on perfusion machines before transplantation, the resistance parameters
      as well as the histological score on the pre-implantation biopsy participate in the
      evaluation of the quality of the graft. The metabolomic profile of the infusion fluid could
      provide additional evidence.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Metabolic assessment in Urine and perfusion liquids
primary purpose: Health Services Research
masking: None (Open Label)
measure: IGF
time frame: 7 days
description: Immediate Graft Function (IGF), defined by serum creatinine less than 250 μM / L at day 7 post-kidney transplant, without requiring dialysis of the recipient patient.
measure: DGF
time frame: 7 days
description: DGF Delayed graft function : Dialysis need within 7 days post-transplant
measure: BANFF-1
time frame: PRE-OPERATIONAL
description: Anatomo-pathological classification of the pre-implantation biopsy according to the revised Banff classification 2013
measure: BANFF-2
time frame: 3 months
description: Anatomo-pathological classification of systematic biopsy at 3 months post-transplant according to the revised Banff classification 2013
arm group label: LifePort® perfusion machine
arm group type: Other
description: Metabolomic analysis of the preservation fluid of the graft, donor and recipient urine by nuclear magnetic resonance spectroscopy, and if possible by liquid and gas chromatography coupled with mass spectrometry.
intervention type: Device
intervention name: LifePort® perfusion machine
description: Renal perfusion on LifePort® machine
arm group label: LifePort® perfusion machine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Franck BRUYERE, MD-PhD
role: Principal Investigator
affiliation: University François Rabelais of TOURS
facility: 
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No