<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/NCT02206373</url>
  </required_header>
  <id_info>
    <org_study_id>201301031RINC</org_study_id>
    <nct_id>NCT02206373</nct_id>
  </id_info>
  <brief_title>How to Dose a Patient According to Renal Function? Glomerular Filtration Rate (GFR) or Creatinine Clearance (ClCr)</brief_title>
  <official_title>How to Dose a Patient According to Renal Function? Glomerular Filtration Rate (GFR) or Creatinine Clearance (ClCr)</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>
      Background： The prevalence of chronic kidney disease (CKD) is high in Taiwan. Though there&#xD;
      are many factors that may affect the measurement of serum creatinine, it is a well-accepted&#xD;
      marker for renal function assessment. The creatinine clearance (ClCr) estimated by&#xD;
      Cockcroft-Gault is commonly used as a reference for dosage adjustment; while the estimated&#xD;
      glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD) is used in&#xD;
      CKD staging. ClCr and eGFR not only have different units, but the results of estimation from&#xD;
      the two varied among races and individuals. Since 2010, US Food and Drug Administration&#xD;
      required both the influences of ClCr and eGFR on the pharmacokinetics of a drug in renal&#xD;
      insufficient patients during pharmacokinetic studies. Because most drugs are excreted through&#xD;
      kidney, an understanding on the relationship between ClCr and eGFR is important to dose&#xD;
      safely and effectively. Furthermore, identifying the factors that may influence the&#xD;
      difference between ClCr and eGFR can provide in-depth consideration during clinical renal&#xD;
      function assessment.&#xD;
&#xD;
      Purpose： The purpose of this study is to analyze the correlation between different ClCr and&#xD;
      eGFR equations in order to provide better renal dose. We also want to find the factors that&#xD;
      may cause the differences between them.&#xD;
&#xD;
      Methods： This study will conduct literature review to understand study population during the&#xD;
      development of different ClCr and eGFR equations, as well as their scope of application.&#xD;
      National Taiwan University Hospital electronic patient database will be used to analyze the&#xD;
      correlation between ClCr and eGFR and to identify factors that may influence the difference&#xD;
      between ClCr and eGFR. The data from patients who have completed 12-hr or 24-hr urine&#xD;
      collection with calculated renal function will be used to verify the applicability of these&#xD;
      equations (including a ClCr equation developed by our institute) in Taiwanese.&#xD;
      Pharmacokinetic principles will be used to analyze the appropriate unit to be used for renal&#xD;
      function while dosing a patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>difference between estimated glomerular filtration rate and creatinine clearance</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">60000</enrollment>
  <condition>Creatinine Clearance Quantitative Trait Locus</condition>
  <condition>Renal Insufficiency, Chronic</condition>
  <eligibility>
    <study_pop>
      <textblock>
        2012.01.01~2012.12.31 adult patients with serum creatinine test result in NTUH&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients with serum creatinine test result&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unstable renal function, hemodialysis, cachexia, pregnancy, severe burn, muscle&#xD;
             atrophy, severe trauma, amputation, liver failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Fe-Lin L Wu, MSCP, PhD</last_name>
    <phone>886-2-23123456</phone>
    <phone_ext>88389</phone_ext>
    <email>flwu@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Tapei</city>
        <zip>10051</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fe-Lin L Wu, MSCP, PhD</last_name>
      <phone>886-2-23123456</phone>
      <phone_ext>88389</phone_ext>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>August 9, 2015</last_update_submitted>
  <last_update_submitted_qc>August 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>creatinine</keyword>
  <keyword>glomerular filtration rate</keyword>
  <keyword>renal insufficiency, chronic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</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/NCT02206373
org study id: 201301031RINC
nct id: NCT02206373
lead sponsor: 
has dmc: No
Background： The prevalence of chronic kidney disease (CKD) is high in Taiwan. Though there
      are many factors that may affect the measurement of serum creatinine, it is a well-accepted
      marker for renal function assessment. The creatinine clearance (ClCr) estimated by
      Cockcroft-Gault is commonly used as a reference for dosage adjustment; while the estimated
      glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD) is used in
      CKD staging. ClCr and eGFR not only have different units, but the results of estimation from
      the two varied among races and individuals. Since 2010, US Food and Drug Administration
      required both the influences of ClCr and eGFR on the pharmacokinetics of a drug in renal
      insufficient patients during pharmacokinetic studies. Because most drugs are excreted through
      kidney, an understanding on the relationship between ClCr and eGFR is important to dose
      safely and effectively. Furthermore, identifying the factors that may influence the
      difference between ClCr and eGFR can provide in-depth consideration during clinical renal
      function assessment.

      Purpose： The purpose of this study is to analyze the correlation between different ClCr and
      eGFR equations in order to provide better renal dose. We also want to find the factors that
      may cause the differences between them.

      Methods： This study will conduct literature review to understand study population during the
      development of different ClCr and eGFR equations, as well as their scope of application.
      National Taiwan University Hospital electronic patient database will be used to analyze the
      correlation between ClCr and eGFR and to identify factors that may influence the difference
      between ClCr and eGFR. The data from patients who have completed 12-hr or 24-hr urine
      collection with calculated renal function will be used to verify the applicability of these
      equations (including a ClCr equation developed by our institute) in Taiwanese.
      Pharmacokinetic principles will be used to analyze the appropriate unit to be used for renal
      function while dosing a patient.
observational model: Cohort
time perspective: Cross-Sectional
measure: difference between estimated glomerular filtration rate and creatinine clearance
time frame: 1 year
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Fe-Lin L Wu, MSCP, PhD
phone: 886-2-23123456
phone ext: 88389
email: flwu@ntu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Renal Insufficiency, Chronic