<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/NCT03234075</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0022</org_study_id>
    <nct_id>NCT03234075</nct_id>
  </id_info>
  <brief_title>Evaluation of a New Regional Organization to Promote Access to Renal Transplantation</brief_title>
  <acronym>TRACE</acronym>
  <official_title>Promoting Access to Renal Transplantation: Impact of a Patient-centered Regional Organization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      Patients with terminal chronic kidney disease (CRD) need renal function supplementation,&#xD;
      namely dialysis or renal transplantation. Transplantation is the most efficient and&#xD;
      cost-effective treatment. Early and equitable access to transplantation is a public health&#xD;
      issue. Access to transplantation is facilitated by early and systematic information and&#xD;
      assessment of patients for inclusion in the national waiting list for transplantation prior&#xD;
      to the onset of dialysis, and by the development of transplantation from living donors. In&#xD;
      France, there are wide disparities in access to national waiting list registration and&#xD;
      transplantation. One of the causes of these inequalities in access would be the disparity in&#xD;
      referral practices to a transplant medical and surgical team authorized to register the&#xD;
      individual on the national waiting list.&#xD;
&#xD;
      The aim of the TRACE study is to evaluate the impact of a new regional organization promoting&#xD;
      renal transplantation on access to renal transplantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">January 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative incidence rate of access to renal transplantation for patients with end-stage renal failure</measure>
    <time_frame>At 24 months after initiation of renal function supplementation</time_frame>
    <description>Access to renal transplantation is defined by:&#xD;
Pre-emptive renal transplantation with living donor or deceased donor&#xD;
Registration on the national waiting list for renal transplantation</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Renal Failure</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Patients supported without regional organization for promotion of renal transplantation Setting : French Auvergne Rhone Alpes region and French Center region</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <description>Patients supported with the regional organization for promotion of renal transplantation Setting : French Auvergne Rhone Alpes region</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Regional organization for promotion of renal transplantation</intervention_name>
    <description>Early identification of candidates for renal transplantation&#xD;
with the help of a care coordinator Inform all patients appropriately about the techniques of renal function supplementation&#xD;
delivered by expert patients and a care coordinator Assist the nephrologists in patient graft pathway&#xD;
Multidisciplinary assessment of patients in dedicated web-conferencing meetings bringing together nephrologists and transplant team (&quot; WebRCP of kidney transplant orientation&quot;)&#xD;
Helping to carry out the pre-graft assessments of patients by a care coordinator</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population participating in the study is composed of patients with a terminal Chronic&#xD;
        Kidney Disease (CRD) requiring renal function supplementation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient older than 18 years and younger than 85 years.&#xD;
&#xD;
          -  Entered in the French Network Epidemiology and Information in Nephrology register&#xD;
&#xD;
          -  Renal function supplementation begun in 2013 -- 2014 (period before regional&#xD;
             organization implementation) or in 2018 -- 2019 (period after regional organization&#xD;
             implementation).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patient followed in a Center of nephrology-dialysis or of Renal transplantation located&#xD;
        outside French Auvergne Rhône Alpes or Center Regions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Myriam PASTURAL-THAUNAT, Dr</last_name>
    <phone>04 72 11 01 50</phone>
    <phone_ext>+33</phone_ext>
    <email>myriam.pastural-thaunat@chu-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Karine POYAU</last_name>
    <phone>04 72 11 53 81</phone>
    <phone_ext>+33</phone_ext>
    <email>karine.poyau@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service de Transplantation, Groupement Hospitalier Edouard Herriot, Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Myriam PASTURAL-THAUNAT, Dr</last_name>
      <phone>04 72 11 01 50</phone>
      <phone_ext>+33</phone_ext>
      <email>myriam.pastural-thaunat@chu-lyon.fr</email>
    </contact>
    <contact_backup>
      <last_name>Karine POYAU</last_name>
      <phone>04 72 11 53 81</phone>
      <phone_ext>+33</phone_ext>
      <email>karine.poyau@chu-lyon.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Myriam PASTURAL-THAUNAT, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>January 27, 2020</last_update_submitted>
  <last_update_submitted_qc>January 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2020</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>Renal Insufficiency</mesh_term>
  </condition_browse>
  <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/NCT03234075
org study id: 69HCL17_0022
nct id: NCT03234075
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with terminal chronic kidney disease (CRD) need renal function supplementation,
      namely dialysis or renal transplantation. Transplantation is the most efficient and
      cost-effective treatment. Early and equitable access to transplantation is a public health
      issue. Access to transplantation is facilitated by early and systematic information and
      assessment of patients for inclusion in the national waiting list for transplantation prior
      to the onset of dialysis, and by the development of transplantation from living donors. In
      France, there are wide disparities in access to national waiting list registration and
      transplantation. One of the causes of these inequalities in access would be the disparity in
      referral practices to a transplant medical and surgical team authorized to register the
      individual on the national waiting list.

      The aim of the TRACE study is to evaluate the impact of a new regional organization promoting
      renal transplantation on access to renal transplantation.
observational model: Other
time perspective: Other
measure: Cumulative incidence rate of access to renal transplantation for patients with end-stage renal failure
time frame: At 24 months after initiation of renal function supplementation
description: Access to renal transplantation is defined by:
Pre-emptive renal transplantation with living donor or deceased donor
Registration on the national waiting list for renal transplantation
arm group label: Control group
description: Patients supported without regional organization for promotion of renal transplantation Setting : French Auvergne Rhone Alpes region and French Center region
arm group label: Intervention group
description: Patients supported with the regional organization for promotion of renal transplantation Setting : French Auvergne Rhone Alpes region
intervention type: Other
intervention name: Regional organization for promotion of renal transplantation
description: Early identification of candidates for renal transplantation
with the help of a care coordinator Inform all patients appropriately about the techniques of renal function supplementation
delivered by expert patients and a care coordinator Assist the nephrologists in patient graft pathway
Multidisciplinary assessment of patients in dedicated web-conferencing meetings bringing together nephrologists and transplant team (" WebRCP of kidney transplant orientation")
Helping to carry out the pre-graft assessments of patients by a care coordinator
arm group label: Intervention group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 84 Years
healthy volunteers: No
last name: Myriam PASTURAL-THAUNAT, Dr
phone: 04 72 11 01 50
phone ext: +33
email: myriam.pastural-thaunat@chu-lyon.fr
last name: Karine POYAU
phone: 04 72 11 53 81
phone ext: +33
email: karine.poyau@chu-lyon.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Renal Insufficiency
sharing ipd: No