<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/NCT03749356</url>
  </required_header>
  <id_info>
    <org_study_id>211KT18008</org_study_id>
    <nct_id>NCT03749356</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients</brief_title>
  <acronym>OPIRUS</acronym>
  <official_title>Multi Center, Non-comparative, Phase IV Study to Evaluate the Efficacy and Safety of Once-Daily Prolonged Release Tacrolimus Capsule(TacroBell SR Cap.) in Kidney Transplant Recipients</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>
      The purpose of this study is to evaluate the efficacy and safety and of Once-Daily Tacrolimus&#xD;
      (TacroBell SR Cap.) in patients who received renal transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the&#xD;
      efficacy and safety of combined Once-Daily Tacrolimus (TacroBell SR Cap.) administration for&#xD;
      24 weeks in patients with immunosuppressive therapies after renal transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2018</start_date>
  <completion_date type="Actual">December 4, 2020</completion_date>
  <primary_completion_date type="Actual">July 30, 2020</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>Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)</measure>
    <time_frame>until 24 weeks</time_frame>
    <description>The frequency and percentage of composite efficacy failure(biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of biopsy-confirmed acute rejection(TCMR, AMR)</measure>
    <time_frame>until 24 weeks</time_frame>
    <description>The frequency and Incidence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pathological results of acute rejection</measure>
    <time_frame>until 24 weeks</time_frame>
    <description>By Banff classification categories</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival rate of transplated organ</measure>
    <time_frame>at 24 weeks</time_frame>
    <description>Kaplan-Meier</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival rate of Patients</measure>
    <time_frame>at 24 weeks</time_frame>
    <description>Kaplan-Meier</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum-Cr, eGFR</measure>
    <time_frame>at 24 weeks</time_frame>
    <description>eGFR using CKD-epi method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate safety of TacroBell SR. cap. from number of participants with adverse events</measure>
    <time_frame>until 24 weeks</time_frame>
    <description>safety data</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">141</enrollment>
  <condition>Kidney Transplant</condition>
  <arm_group>
    <arm_group_label>Once-Daily Tacrolimus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One arm: TacroBell SR Cap.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TacroBell SR cap.</intervention_name>
    <description>Orally, once-daily in the morning&#xD;
After first dose 0.2mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3~12ng/ml for 0 to 3months and then at 3~8ng/ml for 3 to 6months of study treatment.</description>
    <arm_group_label>Once-Daily Tacrolimus</arm_group_label>
    <other_name>Tacrolimus SR cap.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 20 years old(male or female)&#xD;
&#xD;
          -  Patients who are planning to receive a kidney from a deceased or a living&#xD;
             non-related/related donor&#xD;
&#xD;
          -  Agreement with written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously received organs other than kidneys or who are planed to be transplanted&#xD;
             simultaneously&#xD;
&#xD;
          -  Receive a kidney from a donor whose ABO blood type is not compatible with that of the&#xD;
             recipient&#xD;
&#xD;
          -  Receive a kidney from a related donor who showed HLA-0 mismatch (identical)&#xD;
&#xD;
          -  Undergo desensitization therapy with high sensitization&#xD;
&#xD;
          -  Diagnosed with cancer in the last five years [Patients, however, who have recovered&#xD;
             from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer can be&#xD;
             enrolled.]&#xD;
&#xD;
          -  Patients or donors who have positive HIV test result&#xD;
&#xD;
          -  Inadequate for registration under the judgment of the investigator due to severe&#xD;
             gastrointestinal disorders&#xD;
&#xD;
          -  Severe systemic infection requiring treatment&#xD;
&#xD;
          -  Prior to the kidney transplantation&#xD;
&#xD;
               -  Treatment with active liver disease or Liver function test(T-bilirubin, AST,&#xD;
                  ALT)is over 3 times than upper normal limit&#xD;
&#xD;
               -  WBC&lt; 2,500/mm^3, or platelet &lt; 75,000/mm^3, or ANC &lt; 1,300/mm^3&#xD;
&#xD;
          -  Pregnant women or nursing mothers&#xD;
&#xD;
          -  Fertile women who not practice contraception with appropriate methods&#xD;
&#xD;
          -  Participated in other trial within 4 weeks&#xD;
&#xD;
          -  In investigator's judgment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu Seun Kim, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Severance Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>January 3, 2021</last_update_submitted>
  <last_update_submitted_qc>January 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 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>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/NCT03749356
org study id: 211KT18008
nct id: NCT03749356
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety and of Once-Daily Tacrolimus
      (TacroBell SR Cap.) in patients who received renal transplantation.
This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the
      efficacy and safety of combined Once-Daily Tacrolimus (TacroBell SR Cap.) administration for
      24 weeks in patients with immunosuppressive therapies after renal transplantation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)
time frame: until 24 weeks
description: The frequency and percentage of composite efficacy failure(biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)
measure: Incidence of biopsy-confirmed acute rejection(TCMR, AMR)
time frame: until 24 weeks
description: The frequency and Incidence
measure: Pathological results of acute rejection
time frame: until 24 weeks
description: By Banff classification categories
measure: Survival rate of transplated organ
time frame: at 24 weeks
description: Kaplan-Meier
measure: Survival rate of Patients
time frame: at 24 weeks
description: Kaplan-Meier
measure: Serum-Cr, eGFR
time frame: at 24 weeks
description: eGFR using CKD-epi method
measure: Evaluate safety of TacroBell SR. cap. from number of participants with adverse events
time frame: until 24 weeks
description: safety data
arm group label: Once-Daily Tacrolimus
arm group type: Experimental
description: One arm: TacroBell SR Cap.
intervention type: Drug
intervention name: TacroBell SR cap.
description: Orally, once-daily in the morning
After first dose 0.2mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3~12ng/ml for 0 to 3months and then at 3~8ng/ml for 3 to 6months of study treatment.
arm group label: Once-Daily Tacrolimus
other name: Tacrolimus SR cap.
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Yu Seun Kim, Ph.D
role: Principal Investigator
affiliation: Severance Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Tacrolimus