<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/NCT01685086</url>
  </required_header>
  <id_info>
    <org_study_id>201110013RC</org_study_id>
    <nct_id>NCT01685086</nct_id>
  </id_info>
  <brief_title>Surveillance and Follow-up for Latent Tuberculosis Infection and Observation of the Effect of Prophylactic Latent Tuberculosis Treatment in Patients With Severe Chronic Kidney Disease or Receiving Long-term Dialysis</brief_title>
  <official_title>Surveillance and Follow-up for Latent Tuberculosis Infection and Observation of the Effect of Prophylactic Latent Tuberculosis Treatment in Patients With Severe Chronic Kidney Disease or Receiving Long-term Dialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To follow-up the latent tuberculosis infection and evaluate the risk of developing active&#xD;
      tuberculosis in patients with severe chronic kidney disease or receiving long-term dialysis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tuberculosis (TB) remains an important infectious disease worldwide. Taiwan is still an&#xD;
      edemic area. In 2008, there is an incidence of 62 persons having TB per 100,000 population.&#xD;
      To control TB, we should prevent further TB transmission via early diagnosis and treatment of&#xD;
      latent TB. In screening the risk population for TB, patients with renal failure acquiring&#xD;
      long-term dialysis, in addition to close contacts, have higher incidence and mortality than&#xD;
      general population. Moreover, the risk for active TB in dialysis patients is ten to 25 times&#xD;
      larger. In Taiwan, the dialysis group is important because it has higher prevalence (2228 per&#xD;
      in per million people by 2009 annual report of United States Renal Data System) than other&#xD;
      countries in the world. In particular, the dialysis patients usually has an extrapulmonary&#xD;
      presentation for their TB, so diagnosis is always delay. Hence, we should detect latent TB in&#xD;
      those dialysis patients for monitor them from active tuberculosis.&#xD;
&#xD;
      Currently, interferon-gamma release assays (IGRAs) are used for finding out those with latent&#xD;
      TB and have been proven useful for those being immunocompromised, and having BCG vaccination.&#xD;
      For dialysis patients, IGRAs have been tested and been considered better than skin tuberculin&#xD;
      test. However, previous studied rarely observed the patients receiving peritoneal dialysis&#xD;
      and severe chronic kidney disease. Besides, those cross-sectional studies used the indirect&#xD;
      evidence for diagnosis and lacked longitudinal follow-up. We thus conducted this study for&#xD;
      observing the prevalence of latent TB in those receiving hemodialysis or peritoneal dialysis&#xD;
      by using IGRAs. We also kept follow-up for the primary outcome of active TB occurrence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2012</start_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>occurrence of active tuberculosis</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Latent tuberculosis infection</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>To Determine the Prevalence of Latent Tuberculosis in Each Group</condition>
  <condition>To Monitor the Occurrence of Active Tuberculosis</condition>
  <arm_group>
    <arm_group_label>Patients with severe chronic kidney disease</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient with peritoneal dialysis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with hemodialysis</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The patients with severe chronic kidney disease or long term dialysis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  older than 20 years old&#xD;
&#xD;
          -  Estimated CCr &lt; 30 ml/min as group of severe chronic kidney disease&#xD;
&#xD;
          -  Long-term (&gt;3months) dialysis as dialysis group&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal of recruitment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chin-Chung Shu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chin-Chung Shu, MD</last_name>
    <phone>886972653087</phone>
    <email>ccshu139@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chin-Chung Shu, MD</last_name>
    </contact>
    <investigator>
      <last_name>Chin-Chung Shu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2011</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>September 12, 2012</last_update_submitted>
  <last_update_submitted_qc>September 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 13, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>latent tuberculosis infection, tuberculosis, chronic kidney disease, peritoneal dialysis, hemodialysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Latent Tuberculosis</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</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/NCT01685086
org study id: 201110013RC
nct id: NCT01685086
lead sponsor: 
has dmc: No
To follow-up the latent tuberculosis infection and evaluate the risk of developing active
      tuberculosis in patients with severe chronic kidney disease or receiving long-term dialysis
Tuberculosis (TB) remains an important infectious disease worldwide. Taiwan is still an
      edemic area. In 2008, there is an incidence of 62 persons having TB per 100,000 population.
      To control TB, we should prevent further TB transmission via early diagnosis and treatment of
      latent TB. In screening the risk population for TB, patients with renal failure acquiring
      long-term dialysis, in addition to close contacts, have higher incidence and mortality than
      general population. Moreover, the risk for active TB in dialysis patients is ten to 25 times
      larger. In Taiwan, the dialysis group is important because it has higher prevalence (2228 per
      in per million people by 2009 annual report of United States Renal Data System) than other
      countries in the world. In particular, the dialysis patients usually has an extrapulmonary
      presentation for their TB, so diagnosis is always delay. Hence, we should detect latent TB in
      those dialysis patients for monitor them from active tuberculosis.

      Currently, interferon-gamma release assays (IGRAs) are used for finding out those with latent
      TB and have been proven useful for those being immunocompromised, and having BCG vaccination.
      For dialysis patients, IGRAs have been tested and been considered better than skin tuberculin
      test. However, previous studied rarely observed the patients receiving peritoneal dialysis
      and severe chronic kidney disease. Besides, those cross-sectional studies used the indirect
      evidence for diagnosis and lacked longitudinal follow-up. We thus conducted this study for
      observing the prevalence of latent TB in those receiving hemodialysis or peritoneal dialysis
      by using IGRAs. We also kept follow-up for the primary outcome of active TB occurrence.
observational model: Cohort
time perspective: Prospective
measure: occurrence of active tuberculosis
time frame: 2 years
measure: Latent tuberculosis infection
time frame: 2 years
arm group label: Patients with severe chronic kidney disease
arm group label: Patient with peritoneal dialysis
arm group label: Patients with hemodialysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Chin-Chung Shu, MD
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Chin-Chung Shu, MD
phone: 886972653087
email: ccshu139@ntu.edu.tw
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Infections
mesh term: Tuberculosis
mesh term: Latent Tuberculosis
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic