<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/NCT01680952</url>
  </required_header>
  <id_info>
    <org_study_id>4-2011-0920</org_study_id>
    <nct_id>NCT01680952</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) +&#xD;
      Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil&#xD;
      in Kidney Transplant Patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 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>Failure rate in effectiveness of up to 12 months after kidney transplant</measure>
    <time_frame>12 months after kidney transplant</time_frame>
    <description>Biopsy confirmed acute rejection&#xD;
Subjects and graft survival&#xD;
Glomerular filtration rate (GFR)&#xD;
24-hour urine test results at 12 months after kidney transplant: Urine protein, CrCl.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">158</enrollment>
  <condition>Kidney Transplant Patients</condition>
  <arm_group>
    <arm_group_label>A) TEST</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>B) CONTROL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>A) TEST</intervention_name>
    <description>Extended Release Tacrolimus (Advagraf®)&#xD;
① Living The day before surgery: 0.2 mg/kg(morning dose) po, qd Morning on the day of surgery: 0.1 mg/kg po, qd After surgery, the capacity is adjusted according to the trough level. clinical significance, electrolyte level.&#xD;
② Cadaveric Before surgery at once : 0.1 mg/kg within 12hours before surgery. After surgery : 0.2mg/kg po. in the morning After that, the capacity is adjusted according to the trough level. clinical significance, electrolyte level.&#xD;
Sirolimus (Rapamune®):&#xD;
After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level.</description>
    <arm_group_label>A) TEST</arm_group_label>
    <arm_group_label>B) CONTROL</arm_group_label>
    <other_name>1. Test group : Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>B) CONTROL</intervention_name>
    <description>Extended Release Tacrolimus (Advagraf®)&#xD;
: Same as above.&#xD;
Mycophenolate mofetil : After surgery : 500mg/kg po. within 24hrs after reperfusion. After that, daily dose: 1000mg bid</description>
    <arm_group_label>A) TEST</arm_group_label>
    <arm_group_label>B) CONTROL</arm_group_label>
    <other_name>2. Control group: Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients aged over 20 years&#xD;
&#xD;
          -  Patient who is judged would have the benefits of the Extended Release Tacrolimus&#xD;
             (Advagraf®)treatment by the investigator&#xD;
&#xD;
          -  Patients has given written informed consent&#xD;
&#xD;
          -  Patient is a recipient of primary or recipient of primary (a living kidney transplant,&#xD;
             a cadaveric donor.)&#xD;
&#xD;
          -  Patients has received an ABO compatible donor kidney.&#xD;
&#xD;
          -  Complement-dependent Cytotoxic Crossmatch: CDC) result: negative&#xD;
&#xD;
          -  Female patients of child bearing potential must have a negative urine or serum&#xD;
             pregnancy test within 7 days prior to enrollment or upon hospitalization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has previously received an organ transplant other than a kidney.&#xD;
&#xD;
          -  Patient has a known hypersensitivity to tacrolimus, Sirolimus&#xD;
             (Rapamune®),Mycophenolate mofetil.&#xD;
&#xD;
          -  Desensitization&#xD;
&#xD;
          -  HLA-identical&#xD;
&#xD;
          -  Heart Disease; Heart failure (symptom, EF &lt;45%)&#xD;
&#xD;
          -  Lung Disease; Significant chronic obstructive pulmonary disease, restrictive lung&#xD;
             disease&#xD;
&#xD;
          -  Patient has an uncontrolled concomitant infection (including Hepatitis B, Hepatitis C)&#xD;
             or any other unstable&#xD;
&#xD;
          -  malignant tumor history in the 5years prior to enrollment. (except,squamous cell&#xD;
             carcinoma)&#xD;
&#xD;
          -  Patient has received a kidney transplant from non-heart beating donor&#xD;
&#xD;
          -  Cold ischemic time &gt; 30hrs&#xD;
&#xD;
          -  Elevated AST and/or ALT levels greater than 3 times the upper value of the normal&#xD;
             range of the investigational site&#xD;
&#xD;
          -  (ANC)&lt;1,500/mm3, (WBC)&lt;2,500/ mm3, (PLT)&lt;100,000/ mm3&#xD;
&#xD;
          -  ATG: Anti-thymocyte globulin induction&#xD;
&#xD;
          -  Medical condition that could interfere with the study objectives.&#xD;
&#xD;
          -  Patient is currently taking or has been taking an investigational products in the 30&#xD;
             days prior to enrollment.&#xD;
&#xD;
          -  Patient is currently taking or has been taking an prohibited medications in the 28&#xD;
             days prior to enrollment.&#xD;
&#xD;
          -  Patient who is judged not to be adequate by the investigator owing to other reasons&#xD;
&#xD;
          -  Patient is pregnant or lactating.&#xD;
&#xD;
          -  Recipient or donor is known to be seropositive for human immunodeficiency virus.(HIV)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ajou Univeristy Medical Center</name>
      <address>
        <city>Suwon</city>
        <state>KyungKi Province</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook national hospital</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gangnam Severance hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ulsan Univ Hospital</name>
      <address>
        <city>Ulsan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>March 7, 2016</last_update_submitted>
  <last_update_submitted_qc>March 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RECORD study</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycophenolic Acid</mesh_term>
    <mesh_term>Sirolimus</mesh_term>
    <mesh_term>Tacrolimus</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/NCT01680952
org study id: 4-2011-0920
nct id: NCT01680952
lead sponsor: 
has dmc: No
This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) +
      Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil
      in Kidney Transplant Patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Failure rate in effectiveness of up to 12 months after kidney transplant
time frame: 12 months after kidney transplant
description: Biopsy confirmed acute rejection
Subjects and graft survival
Glomerular filtration rate (GFR)
24-hour urine test results at 12 months after kidney transplant: Urine protein, CrCl.
arm group label: A) TEST
arm group type: Active Comparator
arm group label: B) CONTROL
arm group type: Experimental
intervention type: Drug
intervention name: A) TEST
description: Extended Release Tacrolimus (Advagraf®)
① Living The day before surgery: 0.2 mg/kg(morning dose) po, qd Morning on the day of surgery: 0.1 mg/kg po, qd After surgery, the capacity is adjusted according to the trough level. clinical significance, electrolyte level.
② Cadaveric Before surgery at once : 0.1 mg/kg within 12hours before surgery. After surgery : 0.2mg/kg po. in the morning After that, the capacity is adjusted according to the trough level. clinical significance, electrolyte level.
Sirolimus (Rapamune®):
After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level.
arm group label: A) TEST
arm group label: B) CONTROL
other name: 1. Test group : Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®)
intervention type: Drug
intervention name: B) CONTROL
description: Extended Release Tacrolimus (Advagraf®)
: Same as above.
Mycophenolate mofetil : After surgery : 500mg/kg po. within 24hrs after reperfusion. After that, daily dose: 1000mg bid
arm group label: A) TEST
arm group label: B) CONTROL
other name: 2. Control group: Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Mycophenolic Acid
mesh term: Sirolimus
mesh term: Tacrolimus