<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/NCT02208791</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1157-7462</org_study_id>
    <nct_id>NCT02208791</nct_id>
  </id_info>
  <brief_title>Effects of the Quadruple Immunosuppression on Peripheral Blood Lymphocytes and Development of Anti-HLA Antibodies in Kidney Transplant</brief_title>
  <official_title>Evaluation of the Effects of Sirolimus Addition to the Triple Immunosuppression Protocol on Peripheral Blood Lymphocytes and Development of Anti-HLA Antibodies in Sensitized Kidney Transplant Recipients - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effects of sirolimus in the phenotype of&#xD;
      peripheral blood T and B lymphocytes regarding their naïve, memory, effector end regulatory&#xD;
      phenotype and in the development of anti-HLA antibodies among kidney transplant recipients&#xD;
      with high immunological risk for graft rejection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A composite of graft loss and/or death with graft function</measure>
    <time_frame>up to one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with serious and non-serious adverse events and the incidence of biopsy proven acute allograft rejection</measure>
    <time_frame>Up to one year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Kidney Transplantation</condition>
  <arm_group>
    <arm_group_label>Tacrolimus/MPS/Prednisone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will be maintained with current conventional triple immunosuppression. Sirolimus will not be added to this arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sirolimus/Low Tacrolimus/MPS/Prednisone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sirolimus, 2mg once daily, will be added to the maintenance immunosuppression composed of tacrolimus, prednisone and mycophenolate. The prescription of tacrolimus will be tapered down to achieve a peripheral blood trough level between 3 e 5 ng/mL and micophenolate will be reduced to 540mg bid..</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sirolimus</intervention_name>
    <description>Sirolimus, 2mg once daily, will be added to the maintenance immunosuppression composed of tacrolimus, prednisone and mycophenolate. The prescription of tacrolimus will be tapered down to achieve a peripheral blood trough level between 3 e 5 ng/mL and micophenolate will be reduced to 540mg bid.</description>
    <arm_group_label>Sirolimus/Low Tacrolimus/MPS/Prednisone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <arm_group_label>Tacrolimus/MPS/Prednisone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women, ages 18 to 60 years inclusive&#xD;
&#xD;
          -  Percentage of Panel Reactive Antibodies at transplantation &gt; 20%&#xD;
&#xD;
          -  Estimated glomerular filtration rate using MDRD formula at inclusion &gt;29ml/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a history of cancer&#xD;
&#xD;
          -  Subjects with a previous non kidney transplantation&#xD;
&#xD;
          -  Subjects receiving any immunosuppression different of&#xD;
             tacrolimus/prednisone/mycophenolate&#xD;
&#xD;
          -  Subjects with a urinary protein/creatinine ratio greater than 0.3&#xD;
&#xD;
          -  Subjects with active HBV, HCV and HIV infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nelson Z Galante, PhD</last_name>
    <phone>55-11-2661-8089</phone>
    <email>nelson.galante@hc.fm.usp.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fabiana Agena, MS</last_name>
    <phone>55-11-2661-8089</phone>
    <email>fabiana.agena@hc.fm.usp.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elias David-Neto, PhD</last_name>
      <phone>55-11-2661-8089</phone>
      <email>elias.david.neto@attglobal.net</email>
    </contact>
    <contact_backup>
      <last_name>Nelson Z Galante, PhD</last_name>
      <phone>55-11-2661-8089</phone>
      <email>nelson.galante@hc.fm.usp.br</email>
    </contact_backup>
    <investigator>
      <last_name>Elias David-Neto, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nelson Z Galante, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>December 15, 2015</last_update_submitted>
  <last_update_submitted_qc>December 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Kidney Transplantation</keyword>
  <keyword>Graft Rejection</keyword>
  <keyword>Immunossupression</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sirolimus</mesh_term>
  </intervention_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/NCT02208791
org study id: U1111-1157-7462
nct id: NCT02208791
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine the effects of sirolimus in the phenotype of
      peripheral blood T and B lymphocytes regarding their naïve, memory, effector end regulatory
      phenotype and in the development of anti-HLA antibodies among kidney transplant recipients
      with high immunological risk for graft rejection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: A composite of graft loss and/or death with graft function
time frame: up to one year
measure: Number of participants with serious and non-serious adverse events and the incidence of biopsy proven acute allograft rejection
time frame: Up to one year
arm group label: Tacrolimus/MPS/Prednisone
arm group type: Active Comparator
description: This arm will be maintained with current conventional triple immunosuppression. Sirolimus will not be added to this arm
arm group label: Sirolimus/Low Tacrolimus/MPS/Prednisone
arm group type: Experimental
description: Sirolimus, 2mg once daily, will be added to the maintenance immunosuppression composed of tacrolimus, prednisone and mycophenolate. The prescription of tacrolimus will be tapered down to achieve a peripheral blood trough level between 3 e 5 ng/mL and micophenolate will be reduced to 540mg bid..
intervention type: Drug
intervention name: Sirolimus
description: Sirolimus, 2mg once daily, will be added to the maintenance immunosuppression composed of tacrolimus, prednisone and mycophenolate. The prescription of tacrolimus will be tapered down to achieve a peripheral blood trough level between 3 e 5 ng/mL and micophenolate will be reduced to 540mg bid.
arm group label: Sirolimus/Low Tacrolimus/MPS/Prednisone
intervention type: Drug
intervention name: No intervention
arm group label: Tacrolimus/MPS/Prednisone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Nelson Z Galante, PhD
phone: 55-11-2661-8089
email: nelson.galante@hc.fm.usp.br
last name: Fabiana Agena, MS
phone: 55-11-2661-8089
email: fabiana.agena@hc.fm.usp.br
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Brazil
responsible party type: Sponsor
mesh term: Sirolimus