<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/NCT03764124</url>
  </required_header>
  <id_info>
    <org_study_id>Liège KO</org_study_id>
    <nct_id>NCT03764124</nct_id>
  </id_info>
  <brief_title>Observation Study for Prediction of Allograft Survival and Impact of Imaging in Kidney Transplant Recipients.</brief_title>
  <official_title>Prospective Monocentric Observational Study of Kidney Transplant Recipients at the CHU of Liege for the Prediction of Allograft Survival and Impact of Imaging in Clinical Decision-making.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liege</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Liege</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>
      To further develop personalized medicine in kidney transplantation and improve transplant&#xD;
      patient outcomes, attention has been given to define early surrogate endpoints that might aid&#xD;
      therapeutic interventions, and help clinical decision-making.&#xD;
&#xD;
      To adequately predict transplant patients' individual risks of allograft loss and patients'&#xD;
      complications, this would require a complex integration of data, including: donor data,&#xD;
      recipient characteristics, transplant characteristics, biopsies results, immunosuppressive&#xD;
      regimen, allograft infections, acute kidney injuries, recipient immune profiles, protocol and&#xD;
      per cause biopsies and imaging (PET/CT imaging).&#xD;
&#xD;
      This project aims:&#xD;
&#xD;
        1. Assessed the usefulness of 18F-FDG PET/CT imaging in kidney transplantation recipients&#xD;
           presenting with suspected acute rejection who underwent a transplant needle biopsy;&#xD;
&#xD;
        2. To develop a prognostic risk score to predict kidney allograft survival;&#xD;
&#xD;
        3. To evaluate the impact of corticoids withdrawal on long term outcomes (risk of rejection&#xD;
           and impact on bone mineral density);&#xD;
&#xD;
        4. Evaluate the type and the frequencies of complications in our kidney transplant&#xD;
           population&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. The detection of acute rejection in kidney transplant recipients, depends critically on&#xD;
           assessments of serum creatinine, an insensitive measure of renal injury and the&#xD;
           diagnosis relies on renal transplant needle biopsy which is an invasive procedure&#xD;
           associated with a significant risk of bleeding and graft loss and is limited by sampling&#xD;
           error and/or interobserver variability. Moreover, repeated biopsies to evaluate a renal&#xD;
           graft's status pose challenges, including practicability and cost. Consequently, other&#xD;
           sensitive and less invasive modalities, including gene expression profiling and omic&#xD;
           analyses of blood and urine samples as well as in vivo imaging, are currently under&#xD;
           investigation to reinforce our clinical armamentarium for acute rejection diagnosis.&#xD;
           Likewise, it would be useful to non-invasively predict rejection in kidney transplant&#xD;
           recipients with acute renal dysfunction and suspected acute rejection, thereby avoiding&#xD;
           unnecessary transplant biopsy.&#xD;
&#xD;
        2. This study aims to generate a scoring system that predicts individual patients' risk of&#xD;
           long-term kidney allograft failure.&#xD;
&#xD;
        3. Since 2007, the protocol in our institution is to withdraw the corticoids after 3 months&#xD;
           after the protocol biopsy if no sign of rejection is demonstrated. We would like to&#xD;
           evaluate the impact of such decision in the risk of rejection and the long-term&#xD;
           allograft outcome in our patients. We are looking also to the impact on bone mineral&#xD;
           density after corticoids withdrawal in those patients.&#xD;
&#xD;
        4. Evaluate the type and the frequencies of complications in our kidney transplant&#xD;
           population to adapt our daily basis clinical practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2007</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">August 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Imaging</measure>
    <time_frame>Prediction of rejection at time of biopsies</time_frame>
    <description>Prediction model of the PET/CT imaging to predict the histological results of a biopsy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Allograft survival probability post transplantation</measure>
    <time_frame>Allograft survival probability at 1-year post transplantation</time_frame>
    <description>Allograft survival probability calculated from clinical, histological, immunological, and functional variables assessed at the time of transplant and at the time of biopsy at 3-months post transplant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rejection</measure>
    <time_frame>Evaluation of the risk of rejection during follow-up in patients with corticoids withdrawal at 3 months post transplantation</time_frame>
    <description>Risk of rejection rate in patients with corticosteroids withdrawal at 3 months.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Kidney Transplantation</condition>
  <arm_group>
    <arm_group_label>Kidney recipients</arm_group_label>
    <description>Kidney recipients aged over 18 and of all sexes recruited between 2007 and 2020 from the Centre Hospitalier Universitaire de Liege, who have e-GFR follow-up and data from protocol and for cause biopsies available at 1-year post transplant. PET/CT imaging will be performed with patient's approval for protocol and per cause biopsies we performed. Data will be collected in the follow up such as clinical, biological and histological data.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PET/CT imaging</intervention_name>
    <description>The PET/CT procedure was performed using cross-calibrated Philips Gemini TF Big Bore or TF 16 PET/CT systems (Philips Medical Systems, Cleveland, OH) at 201 18 minutes following intravenous injection of a mean dose of 3.2 0.2 MBq/kg of body weight of 18 F-FDG. A low-dose helical CT (5-mm slice thickness, 120-kV tube voltage, and 40-mAs tube current-time product) centered to the renal transplant was performed, followed by PET scanning with two bed positions, each lasting 240 seconds. Images were reconstructed using iterative list mode time-of-flight algorithms. Corrections for attenuation, dead time and random and scatter events were applied.</description>
    <arm_group_label>Kidney recipients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Kidney recipients aged over 18 of all sexes recruited between 2007 and 2020 from the Centre&#xD;
        Hospitalier Universitaire of Liege, who have e-GFR follow-up and data from protocol and for&#xD;
        cause biopsies available at 1-year post transplant. PET/CT imaging will be performed with&#xD;
        patient's approval for protocol and per cause biopsies we performed. Data will be collected&#xD;
        in the follow up such as clinical, biological and histological data.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Kidney recipient transplanted after 2007&#xD;
&#xD;
          -  Kidney recipient over 18 years of age&#xD;
&#xD;
          -  Clinical, biological, immunological and follow up data available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Combined transplantation&#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>FRANCOIS JOURET, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Liege department of Nephrology-Dialysis and Transplantation, and Groupe Interdisciplinaire de Géno-protéomique Appliquée, Cardiovascular Sciences.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Antoine Bouquegneau, MD</last_name>
    <phone>0032473353321</phone>
    <email>antoine.bouquegneau@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laurent Weekers, MD</last_name>
    <email>l.weekers@chuliege.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Liège</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antoine Bouquegneau, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Liege</investigator_affiliation>
    <investigator_full_name>Antoine Bouquegneau</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Allograft survival</keyword>
  <keyword>PET/CT imaging</keyword>
  <keyword>Corticoids withdrawal</keyword>
  <keyword>Bone mineral Density</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/NCT03764124
org study id: Liège KO
nct id: NCT03764124
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To further develop personalized medicine in kidney transplantation and improve transplant
      patient outcomes, attention has been given to define early surrogate endpoints that might aid
      therapeutic interventions, and help clinical decision-making.

      To adequately predict transplant patients' individual risks of allograft loss and patients'
      complications, this would require a complex integration of data, including: donor data,
      recipient characteristics, transplant characteristics, biopsies results, immunosuppressive
      regimen, allograft infections, acute kidney injuries, recipient immune profiles, protocol and
      per cause biopsies and imaging (PET/CT imaging).

      This project aims:

        1. Assessed the usefulness of 18F-FDG PET/CT imaging in kidney transplantation recipients
           presenting with suspected acute rejection who underwent a transplant needle biopsy;

        2. To develop a prognostic risk score to predict kidney allograft survival;

        3. To evaluate the impact of corticoids withdrawal on long term outcomes (risk of rejection
           and impact on bone mineral density);

        4. Evaluate the type and the frequencies of complications in our kidney transplant
           population
1. The detection of acute rejection in kidney transplant recipients, depends critically on
           assessments of serum creatinine, an insensitive measure of renal injury and the
           diagnosis relies on renal transplant needle biopsy which is an invasive procedure
           associated with a significant risk of bleeding and graft loss and is limited by sampling
           error and/or interobserver variability. Moreover, repeated biopsies to evaluate a renal
           graft's status pose challenges, including practicability and cost. Consequently, other
           sensitive and less invasive modalities, including gene expression profiling and omic
           analyses of blood and urine samples as well as in vivo imaging, are currently under
           investigation to reinforce our clinical armamentarium for acute rejection diagnosis.
           Likewise, it would be useful to non-invasively predict rejection in kidney transplant
           recipients with acute renal dysfunction and suspected acute rejection, thereby avoiding
           unnecessary transplant biopsy.

        2. This study aims to generate a scoring system that predicts individual patients' risk of
           long-term kidney allograft failure.

        3. Since 2007, the protocol in our institution is to withdraw the corticoids after 3 months
           after the protocol biopsy if no sign of rejection is demonstrated. We would like to
           evaluate the impact of such decision in the risk of rejection and the long-term
           allograft outcome in our patients. We are looking also to the impact on bone mineral
           density after corticoids withdrawal in those patients.

        4. Evaluate the type and the frequencies of complications in our kidney transplant
           population to adapt our daily basis clinical practice.
observational model: Cohort
time perspective: Prospective
measure: Imaging
time frame: Prediction of rejection at time of biopsies
description: Prediction model of the PET/CT imaging to predict the histological results of a biopsy.
measure: Allograft survival probability post transplantation
time frame: Allograft survival probability at 1-year post transplantation
description: Allograft survival probability calculated from clinical, histological, immunological, and functional variables assessed at the time of transplant and at the time of biopsy at 3-months post transplant.
measure: Rejection
time frame: Evaluation of the risk of rejection during follow-up in patients with corticoids withdrawal at 3 months post transplantation
description: Risk of rejection rate in patients with corticosteroids withdrawal at 3 months.
arm group label: Kidney recipients
description: Kidney recipients aged over 18 and of all sexes recruited between 2007 and 2020 from the Centre Hospitalier Universitaire de Liege, who have e-GFR follow-up and data from protocol and for cause biopsies available at 1-year post transplant. PET/CT imaging will be performed with patient's approval for protocol and per cause biopsies we performed. Data will be collected in the follow up such as clinical, biological and histological data.
intervention type: Diagnostic Test
intervention name: PET/CT imaging
description: The PET/CT procedure was performed using cross-calibrated Philips Gemini TF Big Bore or TF 16 PET/CT systems (Philips Medical Systems, Cleveland, OH) at 201 18 minutes following intravenous injection of a mean dose of 3.2 0.2 MBq/kg of body weight of 18 F-FDG. A low-dose helical CT (5-mm slice thickness, 120-kV tube voltage, and 40-mAs tube current-time product) centered to the renal transplant was performed, followed by PET scanning with two bed positions, each lasting 240 seconds. Images were reconstructed using iterative list mode time-of-flight algorithms. Corrections for attenuation, dead time and random and scatter events were applied.
arm group label: Kidney recipients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: FRANCOIS JOURET, PhD
role: Principal Investigator
affiliation: CHU Liege department of Nephrology-Dialysis and Transplantation, and Groupe Interdisciplinaire de Géno-protéomique Appliquée, Cardiovascular Sciences.
last name: Antoine Bouquegneau, MD
phone: 0032473353321
email: antoine.bouquegneau@gmail.com
last name: Laurent Weekers, MD
email: l.weekers@chuliege.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University of Liege
investigator full name: Antoine Bouquegneau
investigator title: MD
sharing ipd: No