<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/NCT04478968</url>
  </required_header>
  <id_info>
    <org_study_id>MINI.C160.20.001</org_study_id>
    <nct_id>NCT04478968</nct_id>
  </id_info>
  <brief_title>Approach to Vascular Access After Renal Transplantation</brief_title>
  <acronym>AVART</acronym>
  <official_title>The Levels of Fibrosis Biomarkers in Patients After Renal Transplantation in Relation to Arteriovenous Fistula Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wroclaw Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wroclaw Medical University</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 aim of the project is to assess the effect of functioning AVF in renal transplant&#xD;
      patients on fibrosis, inflammation and LVH indicators. Clinical and laboratory parameters&#xD;
      will be compared in a group of 150 patients, 75 patients with a functioning fistula and 75&#xD;
      patients with inactive vascular access. We will assess the impact of functional AVF and the&#xD;
      levels of biomarkers on the survival of patients and transplanted kidneys.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients after kidney transplantation during a routine visit will be asked to participate to&#xD;
      the study. In eligible a number of studies will be conducted:&#xD;
&#xD;
        -  detailed clinical examination&#xD;
&#xD;
        -  routine laboratory tests&#xD;
&#xD;
        -  lung ultrasound&#xD;
&#xD;
        -  muscle strength with a dynamometer&#xD;
&#xD;
        -  ultrasound assessment of upper limb vessels with assessment of fistula function (in the&#xD;
           case of active fistula) and for the possibility of future vascular access&#xD;
&#xD;
        -  blood collection and protection (10-15 ml) for biomarkers&#xD;
&#xD;
        -  survey EQ-5D-5L and LVD-36&#xD;
&#xD;
        -  functional strength test.&#xD;
&#xD;
      The obtained clinical data and test results will be subject to statistical analysis after&#xD;
      anonymization. The impact of individual parameters on long-term prognosis will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 3, 2020</start_date>
  <completion_date type="Anticipated">January 2, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2, 2022</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life with EQ-5D-5L</measure>
    <time_frame>Baseline visit up to 12 months</time_frame>
    <description>The survey results will be compared between the study and control groups to see if the presence of the arteriovenous fistula affects quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prognostic value of biomarkers (NT-proBNP, Il-6, sST2, galectin-3, GDF-15, MMP7, TIMP1)</measure>
    <time_frame>Baseline visit and up to 12 months</time_frame>
    <description>The levels of biomarkers will be measured and the results will be compared between the study and control groups. A prognostic value of the biomarkers will be estimated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospitalization-free survival</measure>
    <time_frame>Up to 12 months from baseline visit</time_frame>
    <description>Hospital-free survival will be reported as the number of patients living 12 months after the initial visit without the need for hospitalization.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Kidney Transplantation</condition>
  <arm_group>
    <arm_group_label>Active AVF</arm_group_label>
    <description>Patients after kidney transplantation with functioning AVF</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No AVF</arm_group_label>
    <description>Patients after kidney transplantation without AVF (thrombosed AVF, history of HD with catheter, history of PD, preemptive transplantation)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>presence of AVF</intervention_name>
    <description>Functioning AVF may have cardiotoxic potential</description>
    <arm_group_label>Active AVF</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have had a kidney transplant belong to the group of patients at increased risk&#xD;
        for cardiovascular disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age&gt; 18 years old&#xD;
&#xD;
          -  kidney transplant&#xD;
&#xD;
          -  &gt;12 months after transplantation&#xD;
&#xD;
          -  stable transplanted kidney function&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  GFR &lt;15 ml / min&#xD;
&#xD;
          -  severe infection within 3 months of testing&#xD;
&#xD;
          -  increase in creatinine concentration&gt; 0.5 mg / dl within 3 months before the test&#xD;
&#xD;
          -  active cancer&#xD;
&#xD;
          -  signs of severe heart failure (NYHA IV)&#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>Krzysztof Letachowicz, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wroclaw Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Krzysztof Letachowicz, MD, PhD</last_name>
    <phone>+48717332546</phone>
    <email>krzysztof.letachowicz@umed.wroc.pl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Nephrology and Transplantation Medicine</name>
      <address>
        <city>Wroclaw</city>
        <zip>55-556</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Krzysztof Letachowicz, MD, PhD</last_name>
      <phone>+48717332546</phone>
      <email>krzysztof.letachowiocz@umed.wroc.pl</email>
    </contact>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Arteriovenous Fistula</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arteriovenous Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04478968
org study id: MINI.C160.20.001
nct id: NCT04478968
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the project is to assess the effect of functioning AVF in renal transplant
      patients on fibrosis, inflammation and LVH indicators. Clinical and laboratory parameters
      will be compared in a group of 150 patients, 75 patients with a functioning fistula and 75
      patients with inactive vascular access. We will assess the impact of functional AVF and the
      levels of biomarkers on the survival of patients and transplanted kidneys.
Patients after kidney transplantation during a routine visit will be asked to participate to
      the study. In eligible a number of studies will be conducted:

        -  detailed clinical examination

        -  routine laboratory tests

        -  lung ultrasound

        -  muscle strength with a dynamometer

        -  ultrasound assessment of upper limb vessels with assessment of fistula function (in the
           case of active fistula) and for the possibility of future vascular access

        -  blood collection and protection (10-15 ml) for biomarkers

        -  survey EQ-5D-5L and LVD-36

        -  functional strength test.

      The obtained clinical data and test results will be subject to statistical analysis after
      anonymization. The impact of individual parameters on long-term prognosis will be assessed.
observational model: Cohort
time perspective: Cross-Sectional
measure: Quality of life with EQ-5D-5L
time frame: Baseline visit up to 12 months
description: The survey results will be compared between the study and control groups to see if the presence of the arteriovenous fistula affects quality of life.
measure: Prognostic value of biomarkers (NT-proBNP, Il-6, sST2, galectin-3, GDF-15, MMP7, TIMP1)
time frame: Baseline visit and up to 12 months
description: The levels of biomarkers will be measured and the results will be compared between the study and control groups. A prognostic value of the biomarkers will be estimated.
measure: Hospitalization-free survival
time frame: Up to 12 months from baseline visit
description: Hospital-free survival will be reported as the number of patients living 12 months after the initial visit without the need for hospitalization.
arm group label: Active AVF
description: Patients after kidney transplantation with functioning AVF
arm group label: No AVF
description: Patients after kidney transplantation without AVF (thrombosed AVF, history of HD with catheter, history of PD, preemptive transplantation)
intervention type: Other
intervention name: presence of AVF
description: Functioning AVF may have cardiotoxic potential
arm group label: Active AVF
Blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Krzysztof Letachowicz, MD, PhD
role: Principal Investigator
affiliation: Wroclaw Medical University
last name: Krzysztof Letachowicz, MD, PhD
phone: +48717332546
email: krzysztof.letachowicz@umed.wroc.pl
facility: 
status: Recruiting
contact: 
country: Poland
responsible party type: Sponsor
mesh term: Arteriovenous Fistula
sharing ipd: Undecided