<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/NCT03764670</url>
  </required_header>
  <id_info>
    <org_study_id>201809018RINB</org_study_id>
    <nct_id>NCT03764670</nct_id>
  </id_info>
  <brief_title>Genetic Factors on Outcomes of Kidney Transplant Patients With Tacrolimus-based Therapy</brief_title>
  <official_title>The Influence of Genetic and Clinical Factors on Clinical Outcomes of Kidney Transplant Patients With Tacrolimus Based Immunosuppression</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to identify the influence of genetic and clinical factors on the&#xD;
      clinical outcomes of kidney transplant patients with tacrolimus (TAC) based immunosuppression&#xD;
      in Taiwan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tacrolimus (TAC) is the most important immunosuppressants for maintenance therapy after&#xD;
      kidney transplantation. Many genetic and clinical factors had been found to have effect on&#xD;
      TAC pharmacokinetics (PK). Whether these factors affect clinical outcomes is still&#xD;
      controversial.&#xD;
&#xD;
      In this retrospective study, investigators will review records of kidney transplant patients&#xD;
      with TAC based immunosuppression recruited from a previous study (IRB approval number:&#xD;
      201512005RINC) to understand the influence of clinical and genetic factors on their 3-years&#xD;
      clinical outcomes, including biopsy-proven acute rejection, patient survival, graft survival&#xD;
      and safety issues of kidney transplant patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Actual">September 22, 2020</completion_date>
  <primary_completion_date type="Actual">October 3, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Acute rejection</measure>
    <time_frame>Within the first 1 year post-transplantation</time_frame>
    <description>The incidence of acute rejection within the first 1 year post-transplantation, estimated with Kaplan-Meier survival analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Graft survival</measure>
    <time_frame>From post-transplantation to Dec 31, 2017</time_frame>
    <description>The incidence of graft loss during the follow-up time, estimated with Kaplan-Meier survival analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient survival</measure>
    <time_frame>From post-transplantation to Dec 31, 2017</time_frame>
    <description>The incidence of death during the follow-up time (number of events or frequency)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kidney function measured by estimated glomerular filtration rate (eGFR)</measure>
    <time_frame>From post-transplantation to Dec 31, 2017</time_frame>
    <description>Kidney function during the follow-up time measured by eGFR (MDRD 4-variable equation, in mL/min/1.73 m^2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events, including post-transplant diabetes mellitus, deterioration of liver function, cancer, infection and hyperlipidemia</measure>
    <time_frame>From post-transplantation to Dec 31, 2017</time_frame>
    <description>The incidence of infection and cancer in number of events or frequency in percentage.&#xD;
The change of liver function : measured by aspartate aminotransferase (AST in U/L), alanine aminotransferase (ALT in U/L), and total bilirubin in mg/dL.&#xD;
Hyperlipidemia: identified by diagnosis and the use of lipid-lowering agents, with follow-up of LDL in mg/dL, HDL in mg/dL, and total cholesterol in mg/dL.&#xD;
Post-transplant diabetes mellitus: identified by diagnosis and the use of antihyperglycemic agents, with follow-up of hemoglobin A1c in percentage and blood glucose in mg/dL.</description>
  </secondary_outcome>
  <enrollment type="Actual">98</enrollment>
  <condition>Kidney Transplantation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Kidney transplant recipients who underwent transplantation at National Taiwan University&#xD;
        Hospital, and received tacrolimus based immunosupression&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Kidney transplantation&#xD;
&#xD;
          2. 20-65 years old&#xD;
&#xD;
          3. Receiving tacrolimus-based immunosuppressants&#xD;
&#xD;
          4. Were recruited in a previous trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Human immunodeficiency virus-positive status&#xD;
&#xD;
          2. Retransplantation or multiorgan transplantation&#xD;
&#xD;
          3. Non-Asian&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meng-Kun Tsai, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>March 11, 2021</last_update_submitted>
  <last_update_submitted_qc>March 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tacrolimus</keyword>
  <keyword>clinical outcomes</keyword>
  <keyword>genetic polymorphism</keyword>
  <keyword>clinical factors</keyword>
  <!-- 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/NCT03764670
org study id: 201809018RINB
nct id: NCT03764670
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to identify the influence of genetic and clinical factors on the
      clinical outcomes of kidney transplant patients with tacrolimus (TAC) based immunosuppression
      in Taiwan.
Tacrolimus (TAC) is the most important immunosuppressants for maintenance therapy after
      kidney transplantation. Many genetic and clinical factors had been found to have effect on
      TAC pharmacokinetics (PK). Whether these factors affect clinical outcomes is still
      controversial.

      In this retrospective study, investigators will review records of kidney transplant patients
      with TAC based immunosuppression recruited from a previous study (IRB approval number:
      201512005RINC) to understand the influence of clinical and genetic factors on their 3-years
      clinical outcomes, including biopsy-proven acute rejection, patient survival, graft survival
      and safety issues of kidney transplant patients.
observational model: Case-Only
time perspective: Retrospective
measure: Acute rejection
time frame: Within the first 1 year post-transplantation
description: The incidence of acute rejection within the first 1 year post-transplantation, estimated with Kaplan-Meier survival analysis
measure: Graft survival
time frame: From post-transplantation to Dec 31, 2017
description: The incidence of graft loss during the follow-up time, estimated with Kaplan-Meier survival analysis
measure: Patient survival
time frame: From post-transplantation to Dec 31, 2017
description: The incidence of death during the follow-up time (number of events or frequency)
measure: Kidney function measured by estimated glomerular filtration rate (eGFR)
time frame: From post-transplantation to Dec 31, 2017
description: Kidney function during the follow-up time measured by eGFR (MDRD 4-variable equation, in mL/min/1.73 m^2).
measure: Incidence of adverse events, including post-transplant diabetes mellitus, deterioration of liver function, cancer, infection and hyperlipidemia
time frame: From post-transplantation to Dec 31, 2017
description: The incidence of infection and cancer in number of events or frequency in percentage.
The change of liver function : measured by aspartate aminotransferase (AST in U/L), alanine aminotransferase (ALT in U/L), and total bilirubin in mg/dL.
Hyperlipidemia: identified by diagnosis and the use of lipid-lowering agents, with follow-up of LDL in mg/dL, HDL in mg/dL, and total cholesterol in mg/dL.
Post-transplant diabetes mellitus: identified by diagnosis and the use of antihyperglycemic agents, with follow-up of hemoglobin A1c in percentage and blood glucose in mg/dL.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Meng-Kun Tsai, Professor
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor