<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/NCT02259296</url>
  </required_header>
  <id_info>
    <org_study_id>CZHKI-HDVA-001</org_study_id>
    <nct_id>NCT02259296</nct_id>
  </id_info>
  <brief_title>Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure</brief_title>
  <acronym>TACTIC</acronym>
  <official_title>Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Changzheng Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>First Affiliated Hospital of Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhongda Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sichuan Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Dalian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Haidian Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai Changzheng Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The timing for arteriovenous fistula (AVF) creation and its effect on target organs in&#xD;
      patients with chronic renal failure will be investigated by multicenter prospective cohort.&#xD;
      Lower estimated glomerular filtration rate (eGFR) patients (eGFR&lt;10ml/min 1.73m2 for patients&#xD;
      without diabetic kidney disease, and eGFR&lt;15ml/min 1.73m2 for diabetic kidney disease) and&#xD;
      higher eGFR patients (eGFR 10-15ml/min 1.73m2 for patients without diabetic kidney disease,&#xD;
      and eGFR 15-20ml/min 1.73m2 for diabetic kidney disease) will be proposed to undertake AVF&#xD;
      creation. Maturation rate and time of AVF will be followed up in 3 months; primary and&#xD;
      secondary patency rate of AVF, AVF construction on cardiac structure, function,&#xD;
      encephalopathy, cerebral vascular lesions and cognitive function will be followed up in the&#xD;
      next 2 years. This multicenter will provide evidence to develop guideline of timing for AVF&#xD;
      creation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maturation rate of AVF</measure>
    <time_frame>3 months</time_frame>
    <description>Assessed by duplex ultrasound. A mature fistula has a flow of over 500 mL/min,is less than 0.6 cm below the surface of the skin, and has a minimal diameter of 0.6 cm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary and secondary patency rate of AVF</measure>
    <time_frame>2 years</time_frame>
    <description>Assessed by duplex ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maturation time of AVF</measure>
    <time_frame>3 months</time_frame>
    <description>Assessed by duplex ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications of AVF</measure>
    <time_frame>2 years</time_frame>
    <description>Assessed by duplex ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AVF creation on ventricular volumes and left ventricular remodeling</measure>
    <time_frame>2 years</time_frame>
    <description>Assessed by doppler echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AVF creation on AVF creation on brain MRI and cognitive functions</measure>
    <time_frame>2 years</time_frame>
    <description>Cognitive functions are assessed by psychic and autonomy scores</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2200</enrollment>
  <condition>Renal Failure, Chronic</condition>
  <arm_group>
    <arm_group_label>Lower eGFR for AVF creation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Higher eGFR for AVF creation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lower eGFR for AVF construction</intervention_name>
    <description>Lower eGFR patients (eGFR&lt;10ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR&lt;15ml/min 1.73m2 for diabetic kidney disease) are proposed to undergo AVF construction</description>
    <arm_group_label>Lower eGFR for AVF creation</arm_group_label>
    <other_name>late AVF construction</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Higher eGFR for AVF construction</intervention_name>
    <description>Higher eGFR patients (eGFR 10-15ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR 15-20ml/min 1.73m2 for diabetic kidney disease) are proposed to undergo AVF construction</description>
    <arm_group_label>Higher eGFR for AVF creation</arm_group_label>
    <other_name>early AVF construction</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic renal failure, without AVF creation;&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR) &lt;15ml/min 1.73m2 for patients without&#xD;
             diabetic kidney disease, and eGFR&lt;20ml/min 1.73m2 for diabetic kidney disease;&#xD;
&#xD;
          -  All study subjects must agree to participate in the study and provide written informed&#xD;
             consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with the history of arteriovenous graft, or central venous catheter, or&#xD;
             peritoneal dialysis catheter placement;&#xD;
&#xD;
          -  Contraindications to AVF construction:&#xD;
&#xD;
               -  Allen's Test is positive, or arterial diameter&lt;2 mm; venous diameter&lt;2.5 mm or&#xD;
                  venous occlusion/stenosis.&#xD;
&#xD;
               -  Local infection.&#xD;
&#xD;
          -  Have any other uncontrolled medical condition (severe heart failure, malignancy,&#xD;
             severe coagulation disorders ).&#xD;
&#xD;
          -  Mental illness that makes the patients unable to complete the trial.&#xD;
&#xD;
          -  Female who is planning to become pregnant, who is pregnant and/or lactating, who is&#xD;
             unwilling to use effective means of contraception.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Changlin Mei</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Nephrology, Changzheng Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiang Gao</last_name>
    <phone>+862181885397</phone>
    <email>gaoxiang43100636@163.com</email>
  </overall_contact>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>October 7, 2014</last_update_submitted>
  <last_update_submitted_qc>October 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Changzheng Hospital</investigator_affiliation>
    <investigator_full_name>Changlin Mei</investigator_full_name>
    <investigator_title>Professor, Director, Division of Nephrology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Arteriovenous Fistula</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <!-- 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/NCT02259296
org study id: CZHKI-HDVA-001
nct id: NCT02259296
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The timing for arteriovenous fistula (AVF) creation and its effect on target organs in
      patients with chronic renal failure will be investigated by multicenter prospective cohort.
      Lower estimated glomerular filtration rate (eGFR) patients (eGFR<10ml/min 1.73m2 for patients
      without diabetic kidney disease, and eGFR<15ml/min 1.73m2 for diabetic kidney disease) and
      higher eGFR patients (eGFR 10-15ml/min 1.73m2 for patients without diabetic kidney disease,
      and eGFR 15-20ml/min 1.73m2 for diabetic kidney disease) will be proposed to undertake AVF
      creation. Maturation rate and time of AVF will be followed up in 3 months; primary and
      secondary patency rate of AVF, AVF construction on cardiac structure, function,
      encephalopathy, cerebral vascular lesions and cognitive function will be followed up in the
      next 2 years. This multicenter will provide evidence to develop guideline of timing for AVF
      creation
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maturation rate of AVF
time frame: 3 months
description: Assessed by duplex ultrasound. A mature fistula has a flow of over 500 mL/min,is less than 0.6 cm below the surface of the skin, and has a minimal diameter of 0.6 cm
measure: Primary and secondary patency rate of AVF
time frame: 2 years
description: Assessed by duplex ultrasound
measure: Maturation time of AVF
time frame: 3 months
description: Assessed by duplex ultrasound
measure: Complications of AVF
time frame: 2 years
description: Assessed by duplex ultrasound
measure: AVF creation on ventricular volumes and left ventricular remodeling
time frame: 2 years
description: Assessed by doppler echocardiography
measure: AVF creation on AVF creation on brain MRI and cognitive functions
time frame: 2 years
description: Cognitive functions are assessed by psychic and autonomy scores
arm group label: Lower eGFR for AVF creation
arm group type: Experimental
arm group label: Higher eGFR for AVF creation
arm group type: Active Comparator
intervention type: Procedure
intervention name: Lower eGFR for AVF construction
description: Lower eGFR patients (eGFR<10ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR<15ml/min 1.73m2 for diabetic kidney disease) are proposed to undergo AVF construction
arm group label: Lower eGFR for AVF creation
other name: late AVF construction
intervention type: Procedure
intervention name: Higher eGFR for AVF construction
description: Higher eGFR patients (eGFR 10-15ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR 15-20ml/min 1.73m2 for diabetic kidney disease) are proposed to undergo AVF construction
arm group label: Higher eGFR for AVF creation
other name: early AVF construction
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Changlin Mei
role: Principal Investigator
affiliation: Division of Nephrology, Changzheng Hospital
last name: Xiang Gao
phone: +862181885397
email: gaoxiang43100636@163.com
responsible party type: Principal Investigator
investigator affiliation: Shanghai Changzheng Hospital
investigator full name: Changlin Mei
investigator title: Professor, Director, Division of Nephrology
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic
mesh term: Arteriovenous Fistula
mesh term: Fistula