<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/NCT01670058</url>
  </required_header>
  <id_info>
    <org_study_id>IM103-074</org_study_id>
    <nct_id>NCT01670058</nct_id>
  </id_info>
  <brief_title>Pattern Of Use Of Belatacept In US Transplant Recipients</brief_title>
  <official_title>Pattern Of Use Of Belatacept In US Transplant Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  The prevalence of Belatacept use&#xD;
&#xD;
        -  The characteristics of Belatacept users and the temporal trends in these characteristics&#xD;
&#xD;
        -  Characteristics of adult kidney-only transplant recipients who are treated with&#xD;
           Belatacept vs. who are treated with Calcineurin inhibitors (CNI)-based regimens at the&#xD;
           time of transplantation, and the temporal trends in these characteristics during 7 years&#xD;
           post approval of Belatacept.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2012</start_date>
  <completion_date type="Actual">June 12, 2018</completion_date>
  <primary_completion_date type="Actual">June 12, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The prevalence of Belatacept use</measure>
    <time_frame>Up to 72 months</time_frame>
    <description>Timeframe: Every 6 months up to 72 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Characteristics of Belatacept users, in terms of age, sex, ethnicity, transplanted organs, donor EBV infection-recipient EBV serostatus, donor CMV infection-recipient CMV serostatus, and the temporal trends in these characteristics</measure>
    <time_frame>Up to 72 months</time_frame>
    <description>EBV = Epstein-Barr virus; CMV = cytomegalovirus; Timeframe: Every 6 months up to 72 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Characteristics of adult kidney-only transplant recipients who are treated with Belatacept vs. who are treated with CNI-based regimens at the time of transplantation and temporal trends in these characteristics during 7 years post approval of Belatacept</measure>
    <time_frame>Up to 72 months</time_frame>
    <description>Characteristics of adult kidney-only transplant recipients assessed are age, sex, ethnicity, EBV serostatus, CMV serostatus, organ characteristics, concomitant immunosuppressive medication use, and type of induction medication use.&#xD;
CNI = calcineurin inhibitors; Timeframe: Every 6 months up to 72 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characteristics of adult EBV seropositive kidney-only transplant recipients treated with Belatacept vs who are treated with CNI-based regimens at time of transplantation &amp; temporal trends in these characteristics during 7 yrs post approval of Belatacept</measure>
    <time_frame>Every 6 months up to 72 months</time_frame>
    <description>Characteristics of adult, EBV seropositive, kidney-only transplant recipients assessed are age, sex, ethnicity, CMV serostatus, organ characteristics, concomitant immunosuppressive medication use, and type of induction medication use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extent of switches to or from Belatacept within one year post-transplant in adult, kidney-only transplant recipients</measure>
    <time_frame>Every 6 months up to 72 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of switchers vs. non-switchers (age, sex, ethnicity, EBV serostatus, CMV serostatus, organ characteristics, concomitant immunosuppressive medication use, and type of induction medication use)</measure>
    <time_frame>Every 6 months up to 72 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporal trend in switches during 7 years post-approval</measure>
    <time_frame>Every 6 months up to 72 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CMV treatment/prophylaxis by CMV serostatus in adult kidney-only transplant recipients who had anti-CMV therapy data recorded in United Network for Organ Sharing (UNOS) and treated with Belatacept vs. CNIs at transplantation</measure>
    <time_frame>Every 6 months up to 72 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CMV treatment/prophylaxis by CMV serostatus in adult kidney-only transplant recipients who had anti-CMV therapy data recorded in UNOS and switched to Belatacept, switched from Belatacept, or did not switch</measure>
    <time_frame>Every 6 months up to 72 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of Belatacept users stratified by EBV serostatus, including age, sex, ethnicity, general medical factors, transplant history (organ, date, graft failure date), and donor organ characteristics</measure>
    <time_frame>Every 6 months up to 72 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">5000</enrollment>
  <condition>Kidney Transplantation: Transplantation, Kidney</condition>
  <arm_group>
    <arm_group_label>Belatacept treated adult kidney-only transplant recipients</arm_group_label>
    <description>All adult kidney-only transplant recipients treated with Nulojix (Belatacept)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CNIs at transplantation</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The cohort for the analyses of all transplants includes all organ transplant recipients who&#xD;
        are reported with Belatacept at transplant&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        For more information regarding BMS clinical trial participation, please visit&#xD;
        www.BMSStudyConnect.com.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  The cohort for the analyses of all transplants includes all organ transplant&#xD;
             recipients who are reported with Belatacept at transplant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>July 12, 2018</last_update_submitted>
  <last_update_submitted_qc>July 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01670058
org study id: IM103-074
nct id: NCT01670058
lead sponsor: 
has dmc: No
-  The prevalence of Belatacept use

        -  The characteristics of Belatacept users and the temporal trends in these characteristics

        -  Characteristics of adult kidney-only transplant recipients who are treated with
           Belatacept vs. who are treated with Calcineurin inhibitors (CNI)-based regimens at the
           time of transplantation, and the temporal trends in these characteristics during 7 years
           post approval of Belatacept.
observational model: Cohort
time perspective: Retrospective
measure: The prevalence of Belatacept use
time frame: Up to 72 months
description: Timeframe: Every 6 months up to 72 months
measure: Characteristics of Belatacept users, in terms of age, sex, ethnicity, transplanted organs, donor EBV infection-recipient EBV serostatus, donor CMV infection-recipient CMV serostatus, and the temporal trends in these characteristics
time frame: Up to 72 months
description: EBV = Epstein-Barr virus; CMV = cytomegalovirus; Timeframe: Every 6 months up to 72 months
measure: Characteristics of adult kidney-only transplant recipients who are treated with Belatacept vs. who are treated with CNI-based regimens at the time of transplantation and temporal trends in these characteristics during 7 years post approval of Belatacept
time frame: Up to 72 months
description: Characteristics of adult kidney-only transplant recipients assessed are age, sex, ethnicity, EBV serostatus, CMV serostatus, organ characteristics, concomitant immunosuppressive medication use, and type of induction medication use.
CNI = calcineurin inhibitors; Timeframe: Every 6 months up to 72 months
measure: Characteristics of adult EBV seropositive kidney-only transplant recipients treated with Belatacept vs who are treated with CNI-based regimens at time of transplantation & temporal trends in these characteristics during 7 yrs post approval of Belatacept
time frame: Every 6 months up to 72 months
description: Characteristics of adult, EBV seropositive, kidney-only transplant recipients assessed are age, sex, ethnicity, CMV serostatus, organ characteristics, concomitant immunosuppressive medication use, and type of induction medication use
measure: Extent of switches to or from Belatacept within one year post-transplant in adult, kidney-only transplant recipients
time frame: Every 6 months up to 72 months
measure: Characteristics of switchers vs. non-switchers (age, sex, ethnicity, EBV serostatus, CMV serostatus, organ characteristics, concomitant immunosuppressive medication use, and type of induction medication use)
time frame: Every 6 months up to 72 months
measure: Temporal trend in switches during 7 years post-approval
time frame: Every 6 months up to 72 months
measure: CMV treatment/prophylaxis by CMV serostatus in adult kidney-only transplant recipients who had anti-CMV therapy data recorded in United Network for Organ Sharing (UNOS) and treated with Belatacept vs. CNIs at transplantation
time frame: Every 6 months up to 72 months
measure: CMV treatment/prophylaxis by CMV serostatus in adult kidney-only transplant recipients who had anti-CMV therapy data recorded in UNOS and switched to Belatacept, switched from Belatacept, or did not switch
time frame: Every 6 months up to 72 months
measure: Characteristics of Belatacept users stratified by EBV serostatus, including age, sex, ethnicity, general medical factors, transplant history (organ, date, graft failure date), and donor organ characteristics
time frame: Every 6 months up to 72 months
arm group label: Belatacept treated adult kidney-only transplant recipients
description: All adult kidney-only transplant recipients treated with Nulojix (Belatacept)
arm group label: CNIs at transplantation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
responsible party type: Sponsor