<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/NCT01663805</url>
  </required_header>
  <id_info>
    <org_study_id>CRAD001ABR21T</org_study_id>
    <nct_id>NCT01663805</nct_id>
  </id_info>
  <brief_title>Effects of the Use of &quot;de Novo&quot; Everolimus in Renal Tranplant Population</brief_title>
  <official_title>Effects of the Use of &quot;de Novo&quot; Everolimus for the Expression of Cytokines in Kidneys From Extended Criteria Donors and With Delayed Graft Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MARIO ABBUD FILHO</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto de Urologia e Nefrologia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open, randomized, single-center study. The selected patients will be first divided&#xD;
      into two major groups according to the type of organ to be transplanted: standard criteria&#xD;
      donor (SCD) or extended criteria (ECD) kidney. Then, each group will be randomly allocated to&#xD;
      one of the treatments: tacrolimus (TAC) or everolimus (EVL).&#xD;
&#xD;
      All patients received induction therapy with basiliximab (BXB) and maintenance with&#xD;
      Mycophenolate Sodium (MYF) and prednisone (P). This study will evaluate as Primary&#xD;
      objectives: To characterize the molecular profile of cytokines in kidneys obtained from&#xD;
      deceased donors such as &quot;standard&quot; (SCD) and extended criteria (ECD) in biopsies taken before&#xD;
      and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in&#xD;
      the expression of these molecules. And as Secondaries objectives: To correlate the pattern of&#xD;
      cytokines with delayed graft function (DGF), cold ischemia time, episodes of acute rejection&#xD;
      and patient and graft survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 80 patients will participate in the study, being distributed into 4 groups of 20&#xD;
      individuals. In a pilot study to assess the interventional effect of the mmediate use of EVL&#xD;
      on the cytokine profile of ECD and SCD kidneys, compared to conventional immunosuppressive&#xD;
      therapy with TAC, no statistical power analysis could be performed a priori.&#xD;
&#xD;
      Definitions of Extended Criteria Donor and Delayed Graft Function (DGF) Deceased donors aged&#xD;
      ≥ 60 years or aged between 50 and 59 years and with at least two of the following risk&#xD;
      factors: history of systemic hypertension terminal creatinine levels &gt; 1.5 mg/dL or death by&#xD;
      a cerebrovascular accident.&#xD;
&#xD;
      DGF (delayed graft function) is defined as the need for dialysis in the first 7 days after&#xD;
      transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>Molecular profile of cytokines</measure>
    <time_frame>12 months</time_frame>
    <description>To characterize the molecular profile of cytokines in kidneys obtained from deceased donors such as &quot;standard&quot; (SCD) and extended criteria (ECD) in biopsies taken before and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in the expression of these molecules.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pattern of cytokines with DGF, cold ischemia time, episodes of acute rejection</measure>
    <time_frame>12 months</time_frame>
    <description>To correlate the pattern of cytokines with DGF, cold ischemia time, episodes of acute rejection and patient and graft survival</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Delayed Function of Renal Transplant</condition>
  <arm_group>
    <arm_group_label>Everolimus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SCD/ECD: BXB (2x20mg, D1 and D4) + EVL (3.0 -8.0ng/ml) + MYF (1440mg/d)+ Prednisone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mycophenolate sodium</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>SCD/ECD: BXB (2x20mg, D1 and D4) + TAC + MYF (1440mg/d)+ Prednisone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Everolimus</intervention_name>
    <description>Everolimus is started immediately after transplantation, the dosage of 1.5 mg twice a day, adjusted to achieve and maintain the blood level of 3-8 ng/mL.</description>
    <arm_group_label>Everolimus</arm_group_label>
    <other_name>Certican</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years (black and white subjects);&#xD;
&#xD;
          -  End-stage renal disease with indication for transplantation (primary deceased-donor&#xD;
             kidney transplant)&#xD;
&#xD;
          -  &quot;Standard&quot; traditional (SCD) or extended criteria (ECD) donor;&#xD;
&#xD;
          -  Informed consent form duly signed before SCD or ECD kidney transplantation.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  The subject, in the opinion of the investigator, is not able to complete the study&#xD;
             protocol;&#xD;
&#xD;
          -  Recipient of live-donor kidney graft;&#xD;
&#xD;
          -  Multiple organ transplant recipient;&#xD;
&#xD;
          -  Evidence of large systemic or localized infection;&#xD;
&#xD;
          -  Evidence of infiltration, cavitation or consolidation on chest X-rays obtained during&#xD;
             the evaluation in the screening / baseline visit;&#xD;
&#xD;
          -  Use of any drug under investigation or treatment until up to 4 weeks before&#xD;
             transplantation;&#xD;
&#xD;
          -  Known or suspected hypersensitivity to tacrolimus, everolimus or mycophenolate sodium;&#xD;
&#xD;
          -  Immunosuppressive therapies in addition to those described for this study;&#xD;
&#xD;
          -  Hypersensitized patients (PRA &gt; 30%);&#xD;
&#xD;
          -  Patients with HIV+ or Hepatitis B or C virus infection.&#xD;
&#xD;
          -  Patients for whom T0 and T15 biopsies were not taken.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mario Abbud, MD.PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto de Urologia e Nefrologia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mario Abbud, MD.PhD</last_name>
    <phone>551740099191</phone>
    <email>mabbud@terra.com.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amanda Calori</last_name>
    <phone>551740099167</phone>
    <email>estudos@iun.com.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Instituto de Urologia e Nefrologia</name>
      <address>
        <city>São José do Rio Preto</city>
        <state>São Paulo</state>
        <zip>15015-200</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mario Abbud, MD.PhD</last_name>
      <phone>551740099191</phone>
      <email>mabbud@terra.com.br</email>
    </contact>
    <contact_backup>
      <last_name>Amanda Calori</last_name>
      <phone>551740099167</phone>
      <email>estudos@iun.com.br</email>
    </contact_backup>
    <investigator>
      <last_name>Mario Abbud, MD.PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Instituto de Urologia e Nefrologia</name>
      <address>
        <city>São José do Rio Preto</city>
        <state>São Paulo</state>
        <zip>15015-200</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mario Abbud, MD,Phd</last_name>
      <phone>551740099191</phone>
      <email>mabbud@terra.com.br</email>
    </contact>
    <contact_backup>
      <last_name>Amanda Calori</last_name>
      <phone>551740099191</phone>
      <email>estudos@iun.com.br</email>
    </contact_backup>
    <investigator>
      <last_name>Mario Abbud, MD,Phd</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ida Fernandes, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Instituto de Urologia e Nefrologia</name>
      <address>
        <city>São José do Rio PReto</city>
        <state>São Paulo</state>
        <zip>15015200</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mario Abbud, MD,Phd</last_name>
      <phone>551740099191</phone>
      <email>mabbud@terra.com.br</email>
    </contact>
    <contact_backup>
      <last_name>Amanda Calori</last_name>
      <phone>551740099167</phone>
      <email>estudos@iun.com.br</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2012</verification_date>
  <study_first_submitted>April 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>August 9, 2012</last_update_submitted>
  <last_update_submitted_qc>August 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Instituto de Urologia e Nefrologia</investigator_affiliation>
    <investigator_full_name>MARIO ABBUD FILHO</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Extended Criteria Donor</keyword>
  <keyword>Delayed Graft Function</keyword>
  <keyword>DGF</keyword>
  <keyword>Deceased donors aged ≥ 60 years</keyword>
  <keyword>aged between 50 and 59 years</keyword>
  <keyword>history of systemic hypertension</keyword>
  <keyword>terminal creatinine levels &gt; 1.5 mg/dL</keyword>
  <keyword>death by a cerebrovascular accident</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delayed Graft Function</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Everolimus</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/NCT01663805
org study id: CRAD001ABR21T
nct id: NCT01663805
lead sponsor: 
has dmc: No
This is an open, randomized, single-center study. The selected patients will be first divided
      into two major groups according to the type of organ to be transplanted: standard criteria
      donor (SCD) or extended criteria (ECD) kidney. Then, each group will be randomly allocated to
      one of the treatments: tacrolimus (TAC) or everolimus (EVL).

      All patients received induction therapy with basiliximab (BXB) and maintenance with
      Mycophenolate Sodium (MYF) and prednisone (P). This study will evaluate as Primary
      objectives: To characterize the molecular profile of cytokines in kidneys obtained from
      deceased donors such as "standard" (SCD) and extended criteria (ECD) in biopsies taken before
      and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in
      the expression of these molecules. And as Secondaries objectives: To correlate the pattern of
      cytokines with delayed graft function (DGF), cold ischemia time, episodes of acute rejection
      and patient and graft survival.
A total of 80 patients will participate in the study, being distributed into 4 groups of 20
      individuals. In a pilot study to assess the interventional effect of the mmediate use of EVL
      on the cytokine profile of ECD and SCD kidneys, compared to conventional immunosuppressive
      therapy with TAC, no statistical power analysis could be performed a priori.

      Definitions of Extended Criteria Donor and Delayed Graft Function (DGF) Deceased donors aged
      ≥ 60 years or aged between 50 and 59 years and with at least two of the following risk
      factors: history of systemic hypertension terminal creatinine levels > 1.5 mg/dL or death by
      a cerebrovascular accident.

      DGF (delayed graft function) is defined as the need for dialysis in the first 7 days after
      transplantation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Molecular profile of cytokines
time frame: 12 months
description: To characterize the molecular profile of cytokines in kidneys obtained from deceased donors such as "standard" (SCD) and extended criteria (ECD) in biopsies taken before and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in the expression of these molecules.
measure: Pattern of cytokines with DGF, cold ischemia time, episodes of acute rejection
time frame: 12 months
description: To correlate the pattern of cytokines with DGF, cold ischemia time, episodes of acute rejection and patient and graft survival
arm group label: Everolimus
arm group type: Active Comparator
description: SCD/ECD: BXB (2x20mg, D1 and D4) + EVL (3.0 -8.0ng/ml) + MYF (1440mg/d)+ Prednisone
arm group label: mycophenolate sodium
arm group type: No Intervention
description: SCD/ECD: BXB (2x20mg, D1 and D4) + TAC + MYF (1440mg/d)+ Prednisone
intervention type: Drug
intervention name: Everolimus
description: Everolimus is started immediately after transplantation, the dosage of 1.5 mg twice a day, adjusted to achieve and maintain the blood level of 3-8 ng/mL.
arm group label: Everolimus
other name: Certican
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mario Abbud, MD.PhD
role: Principal Investigator
affiliation: Instituto de Urologia e Nefrologia
last name: Mario Abbud, MD.PhD
phone: 551740099191
email: mabbud@terra.com.br
last name: Amanda Calori
phone: 551740099167
email: estudos@iun.com.br
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: Instituto de Urologia e Nefrologia
investigator full name: MARIO ABBUD FILHO
investigator title: Principal Investigator
mesh term: Delayed Graft Function
mesh term: Everolimus