<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/NCT03794492</url>
  </required_header>
  <id_info>
    <org_study_id>223KT17017</org_study_id>
    <nct_id>NCT03794492</nct_id>
  </id_info>
  <brief_title>Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome</brief_title>
  <official_title>Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome: Open-label, Multi-center, Single Arm, Phase 4 Trial (DoSAKOM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chong Kun Dang Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chong Kun Dang Pharmaceutical</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>
      Efficacy and Safety of My-Rept® (Mycophenolate Mofetil 500mg/Tab. or 250mg/Cap.) in&#xD;
      Combination with Tacrolimus, Methylprednisolone, Simulect in Kidney Transplant Patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multi-center, non-comparative and phase IV clinical trial that evaluates&#xD;
      incidence of Donor-Specific Antibody for 36 months after kidney transplantation when&#xD;
      administered with Tacrolimus, Mycophenolate mofetil, and corticosteroid&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 31, 2018</start_date>
  <completion_date type="Anticipated">December 29, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 11, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>DSA(Donor-specific Anti-HLA Antibody)</measure>
    <time_frame>36 months</time_frame>
    <description>Incidence of DSA(Donor-specific Anti-HLA Antibody) up to 36months after Kidney transplantation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of composite efficacy failure</measure>
    <time_frame>12, 24, 36months</time_frame>
    <description>The frequency and percentage of composite efficacy failure (Treated-BPAMR &amp; ACR, graft loss, death and follow-up loss)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">169</enrollment>
  <condition>Kidney Transplant</condition>
  <arm_group>
    <arm_group_label>Mycophenolate mofetil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One arm: Mycophenolate mofetil 500mg Tab. or 250mg Cap.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mycophenolate mofetil 500mg Tab. or 250mg Cap.</intervention_name>
    <description>- Orally, up to 1g BID(total 2g daily)</description>
    <arm_group_label>Mycophenolate mofetil</arm_group_label>
    <other_name>Myrept® Cap./Tab.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tacrolimus</intervention_name>
    <description>- Orally, check the blood ceocentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3-8ng/ml</description>
    <arm_group_label>Mycophenolate mofetil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylprednisolone/prednisolone</intervention_name>
    <description>- Methyprednisolone 500mg / Prednisolone 5mg</description>
    <arm_group_label>Mycophenolate mofetil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Basiliximab</intervention_name>
    <description>- IV, 20mg(before Kidney transplat) / 20mg(Day 4 of kidney transplant)</description>
    <arm_group_label>Mycophenolate mofetil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Over 19 years old(male or female)&#xD;
&#xD;
          2. Patients who are planning to receive a kidney from a deceased or a living&#xD;
             unrelated/related donor&#xD;
&#xD;
          3. Agreement with written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Donor's HLA antigen matches recipient or the Degree of Mis-Match is 0&#xD;
&#xD;
          2. Patients with high sensitization who need desensitization therapy&#xD;
&#xD;
          3. Multi organ recipients or previous transplant with any organs&#xD;
&#xD;
          4. Diagnosed with cancer within five years&#xD;
&#xD;
          5. Patient who receive kidney from ABO incompatibility donor or Lymphocyte cross-match&#xD;
             positive donor&#xD;
&#xD;
          6. Patients who have positive HIV, HBsAg or Anti-HCV test result&#xD;
&#xD;
          7. At screening&#xD;
&#xD;
               -  Under treatment for active liver disease, or Over 3times upper than normal range&#xD;
                  of liver function test (T-bilirubin, AST, ALT)&#xD;
&#xD;
               -  WBC&lt;2,500/mm3, PLT &lt;50,000/mm3, ANC&lt;1,500/mm3&#xD;
&#xD;
          8. Pregnant or lactating women&#xD;
&#xD;
          9. In investigator's judgment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chang-Kwan Oh, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Ajou University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>July 6, 2021</last_update_submitted>
  <last_update_submitted_qc>July 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycophenolic Acid</mesh_term>
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Tacrolimus</mesh_term>
    <mesh_term>Basiliximab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03794492
org study id: 223KT17017
nct id: NCT03794492
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Efficacy and Safety of My-Rept® (Mycophenolate Mofetil 500mg/Tab. or 250mg/Cap.) in
      Combination with Tacrolimus, Methylprednisolone, Simulect in Kidney Transplant Patients
This study is a multi-center, non-comparative and phase IV clinical trial that evaluates
      incidence of Donor-Specific Antibody for 36 months after kidney transplantation when
      administered with Tacrolimus, Mycophenolate mofetil, and corticosteroid
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: DSA(Donor-specific Anti-HLA Antibody)
time frame: 36 months
description: Incidence of DSA(Donor-specific Anti-HLA Antibody) up to 36months after Kidney transplantation
measure: Incidence of composite efficacy failure
time frame: 12, 24, 36months
description: The frequency and percentage of composite efficacy failure (Treated-BPAMR & ACR, graft loss, death and follow-up loss)
arm group label: Mycophenolate mofetil
arm group type: Experimental
description: One arm: Mycophenolate mofetil 500mg Tab. or 250mg Cap.
intervention type: Drug
intervention name: Mycophenolate mofetil 500mg Tab. or 250mg Cap.
description: - Orally, up to 1g BID(total 2g daily)
arm group label: Mycophenolate mofetil
other name: Myrept® Cap./Tab.
intervention type: Drug
intervention name: Tacrolimus
description: - Orally, check the blood ceocentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3-8ng/ml
arm group label: Mycophenolate mofetil
intervention type: Drug
intervention name: Methylprednisolone/prednisolone
description: - Methyprednisolone 500mg / Prednisolone 5mg
arm group label: Mycophenolate mofetil
intervention type: Drug
intervention name: Basiliximab
description: - IV, 20mg(before Kidney transplat) / 20mg(Day 4 of kidney transplant)
arm group label: Mycophenolate mofetil
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Chang-Kwan Oh, Ph.D
role: Study Chair
affiliation: Ajou University School of Medicine
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Mycophenolic Acid
mesh term: Methylprednisolone
mesh term: Prednisolone
mesh term: Tacrolimus
mesh term: Basiliximab
sharing ipd: No