<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/NCT02251691</url>
  </required_header>
  <id_info>
    <org_study_id>201401105MIPA</org_study_id>
    <nct_id>NCT02251691</nct_id>
  </id_info>
  <brief_title>Influence of Once-daily Versus Twice-daily Immunosuppressant on Renal Transplant</brief_title>
  <official_title>The Influence of Once-daily Versus Twice-daily Immunosuppressive Regimen on Drug Compliance in Patients After Renal Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Astellas Pharma Taiwan, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study was to compare the drug compliance in patients after renal&#xD;
      transplantation under once or twice-daily tacrolimus-based immunosuppressive regimen.&#xD;
&#xD;
      The rationale for this study is to access the influence of once-daily prolonged-release&#xD;
      tacrolimus versus standard twice-daily tacrolimus on drug compliance in renal transplantation&#xD;
      recipients base on the assumption that once-daily dosing regimen may help to improve drug&#xD;
      compliance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a prospective, two-arm randomized and open-label, phase IV study to&#xD;
      compare the drug compliance in patients under prolonged-release once-daily tacrolimus versus&#xD;
      standard twice-daily tacrolimus based regimen after de novo renal transplantation.&#xD;
&#xD;
      The investigators will evaluate the drug compliance of the patients under once or twice-daily&#xD;
      tacrolimus-based regimen using the medication scale BAAIS® (basal assessment of adherence&#xD;
      with immunosuppressive medication scale)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 9, 2014</start_date>
  <completion_date type="Anticipated">March 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2020</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>basal assessment of adherence with immunosuppressive medication scale</measure>
    <time_frame>12 months</time_frame>
    <description>We will evaluate the drug compliance of the patients under once or twice-daily tacrolimus-based regimen using the medication scale BAAIS® (basal assessment of adherence with immunosuppressive medication scale)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>serum creatinine level</measure>
    <time_frame>12 months</time_frame>
    <description>We will evaluate the serum creatinine level of the patients enrolled in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>graft survival</measure>
    <time_frame>12 months</time_frame>
    <description>We will evaluate the graft survival of the patients enrolled in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient survival</measure>
    <time_frame>12 months</time_frame>
    <description>We will evaluate the patient survival of the patients enrolled in this study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Adherence to Medication Regime</condition>
  <arm_group>
    <arm_group_label>Advagraf</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Take Advagraf once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prograf</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Take tacrolimus twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Advagraf</intervention_name>
    <description>Compare the drug compliance between once daily or twice daily regimen</description>
    <arm_group_label>Advagraf</arm_group_label>
    <other_name>Advagraf once daily</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prograf</intervention_name>
    <description>Compare the drug compliance between once daily or twice daily regimen</description>
    <arm_group_label>Prograf</arm_group_label>
    <other_name>Prograf twice daily</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Male and female adult patients who are to receive renal transplantation may enter the&#xD;
        study. The intention is to enroll 90 patients who have fulfilled inclusion/exclusion&#xD;
        criteria into the study. Sixty patients will receive prolonged-release once-daily&#xD;
        tacrolimus based therapy; the other thirty patients will receive standard twice-daily&#xD;
        tacrolimus based therapy.&#xD;
&#xD;
        Inclusion criteria&#xD;
&#xD;
          -  Male or female patients at 20-65 years of age undergoing renal transplantation&#xD;
&#xD;
          -  Patients who have been informed of the potential risks and side effects of the study&#xD;
&#xD;
          -  Female patients of childbearing potential must agree to maintain effective birth&#xD;
             control during the study.&#xD;
&#xD;
          -  Patients have been fully informed and have given written informed consent to&#xD;
             participate in the study&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Donor age greater than 65 years&#xD;
&#xD;
          -  Patients receiving a perfectly matched kidney (6 matches HLA-A, B, DR)&#xD;
&#xD;
          -  Patients who are recipients of multiple solid organ transplants&#xD;
&#xD;
          -  Patients undergoing second or subsequent transplantation&#xD;
&#xD;
          -  Patients with pre-transplant PRA &gt; 20%&#xD;
&#xD;
          -  Patients with ABO incompatibility or positive lymphocytotoxicity&#xD;
&#xD;
          -  Patients with severe, active infection&#xD;
&#xD;
          -  Patients who have an abnormal liver profile such as ALT, AST, alkaline phosphatase or&#xD;
             total bilirubin &gt;3 times the upper normal limit&#xD;
&#xD;
          -  Patient who are HIV-positive or hepatitis C (PCR+ only) B surface antigen positive&#xD;
&#xD;
          -  Patients who have been treated with an investigational drug or therapy within one&#xD;
             month prior to entry or who will be so treated within 6 months of transplantation&#xD;
&#xD;
          -  Patients with a history of malignancy within the last five years except excised&#xD;
             squamous or basal cell carcinoma&#xD;
&#xD;
          -  Patients with a history of alcohol or drug abuse or signs of alcohol-induced organ&#xD;
             damage, mental dysfunction or other factors limiting their ability to comply fully&#xD;
             with the study requirements.&#xD;
&#xD;
          -  Patients who require on-going dosing with a systemic immunosuppressive drugs prior to&#xD;
             transplantation.&#xD;
&#xD;
          -  Pregnant woman or breast-feeding mother during the period of this study.&#xD;
&#xD;
          -  Patients who are allergy to tacrolimus, macrolide antibiotics, steroid or&#xD;
             mycophenolate mofetil.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chin-Yuan Lee</last_name>
    <role>Principal Investigator</role>
    <affiliation>hospital medical school affiliations</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chin-Yuan Lee</last_name>
    <phone>+886-972651446</phone>
    <email>gs2119@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chin-Yuan Lee</last_name>
      <phone>+886-972651446</phone>
      <email>gs2119@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>June 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>March 31, 2019</last_update_submitted>
  <last_update_submitted_qc>March 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Compliance</keyword>
  <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/NCT02251691
org study id: 201401105MIPA
nct id: NCT02251691
lead sponsor: 
collaborator: 
has dmc: No
The main objective of this study was to compare the drug compliance in patients after renal
      transplantation under once or twice-daily tacrolimus-based immunosuppressive regimen.

      The rationale for this study is to access the influence of once-daily prolonged-release
      tacrolimus versus standard twice-daily tacrolimus on drug compliance in renal transplantation
      recipients base on the assumption that once-daily dosing regimen may help to improve drug
      compliance.
This study will be a prospective, two-arm randomized and open-label, phase IV study to
      compare the drug compliance in patients under prolonged-release once-daily tacrolimus versus
      standard twice-daily tacrolimus based regimen after de novo renal transplantation.

      The investigators will evaluate the drug compliance of the patients under once or twice-daily
      tacrolimus-based regimen using the medication scale BAAIS® (basal assessment of adherence
      with immunosuppressive medication scale)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: basal assessment of adherence with immunosuppressive medication scale
time frame: 12 months
description: We will evaluate the drug compliance of the patients under once or twice-daily tacrolimus-based regimen using the medication scale BAAIS® (basal assessment of adherence with immunosuppressive medication scale)
measure: serum creatinine level
time frame: 12 months
description: We will evaluate the serum creatinine level of the patients enrolled in this study.
measure: graft survival
time frame: 12 months
description: We will evaluate the graft survival of the patients enrolled in this study.
measure: patient survival
time frame: 12 months
description: We will evaluate the patient survival of the patients enrolled in this study.
arm group label: Advagraf
arm group type: Experimental
description: Take Advagraf once daily
arm group label: Prograf
arm group type: Active Comparator
description: Take tacrolimus twice daily
intervention type: Drug
intervention name: Advagraf
description: Compare the drug compliance between once daily or twice daily regimen
arm group label: Advagraf
other name: Advagraf once daily
intervention type: Drug
intervention name: Prograf
description: Compare the drug compliance between once daily or twice daily regimen
arm group label: Prograf
other name: Prograf twice daily
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Chin-Yuan Lee
role: Principal Investigator
affiliation: hospital medical school affiliations
last name: Chin-Yuan Lee
phone: +886-972651446
email: gs2119@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Tacrolimus