<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/NCT01681134</url>
  </required_header>
  <id_info>
    <org_study_id>FKC-016</org_study_id>
    <nct_id>NCT01681134</nct_id>
  </id_info>
  <brief_title>A Comparison of the Effects of Extended Release Tacrolimus (Advagraf®) vs. Immediate Release Tacrolimus (Prograf®) on Kidney Function in Healthy Male Volunteers</brief_title>
  <official_title>A Comparison of Effects of Short-Term Steady State Low Dose Exposure of Extended Release (Advagraf®) and Immediate Release (Prograf®) Formulations of Tacrolimus on Renal Perfusion and Function in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Canada, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the drug profiles (pharmacokinetics) and effects&#xD;
      (pharmacodynamics) of Advagraf® and Prograf® on the kidneys.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 2 Period study. In Period 1, subjects will be assigned randomly to receive&#xD;
      Advagraf® or Prograf® administered once or twice daily, respectively, for a period of 10&#xD;
      days. In Period 2, subjects will be converted from Advagraf® to Prograf® or from Prograf® to&#xD;
      Advagraf® for 10 additional days of dosing. Dose adjustments will be made based on the&#xD;
      monitoring of drug levels in blood.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effective Renal Plasma Flow (ERPF)</measure>
    <time_frame>up to Day 20</time_frame>
    <description>Estimated by aminohippurate sodium (PAH) clearance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glomerular Filtration Rate (GFR)</measure>
    <time_frame>Pre-dose (Day -4), Day 10, Day 20</time_frame>
    <description>Estimated by sinistrin clearance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Advagraf followed by Prograf</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Prograf followed by Advagraf</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Advagraf®</intervention_name>
    <description>oral</description>
    <arm_group_label>Advagraf followed by Prograf</arm_group_label>
    <arm_group_label>Prograf followed by Advagraf</arm_group_label>
    <other_name>tacrolimus XL, FK506E</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prograf®</intervention_name>
    <description>oral</description>
    <arm_group_label>Advagraf followed by Prograf</arm_group_label>
    <arm_group_label>Prograf followed by Advagraf</arm_group_label>
    <other_name>tacrolimus, FK506</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caucasian&#xD;
&#xD;
          -  No previous/current history of infection, cerebrovascular, neurological,&#xD;
             cardiovascular, endocrine, pulmonary, immunologic or metabolic disease or significant&#xD;
             systemic disease, glucose intolerance, gout or hematological disorder&#xD;
&#xD;
          -  Normal 12-lead Electrocardiogram (ECG)&#xD;
&#xD;
          -  Systolic blood pressure &lt;140 mm Hg and diastolic blood pressure &lt;90 mm Hg&#xD;
&#xD;
          -  Non-smoker within 3 months prior to screening&#xD;
&#xD;
          -  Willing to abstain from alcohol during the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive screen for illicit drug or alcohol consumption&#xD;
&#xD;
          -  Subject has hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or history of&#xD;
             cancer (excluding completely excised squamous or basal cell carcinoma)&#xD;
&#xD;
          -  Positive tuberculin skin test or known history of tuberculosis infection&#xD;
&#xD;
          -  Known history of serious head injuries, seizures or eating disorders&#xD;
&#xD;
          -  Body Mass Index &lt;18.0 or &gt;30.0&#xD;
&#xD;
          -  History of renal dysfunction, clinically significant creatinine or clinically&#xD;
             significant abnormal liver function tests, hemoglobin &lt;130 g/L&#xD;
&#xD;
          -  Plasma donation ≥ 500 mL within 7 days prior to first dose of study drug, donation or&#xD;
             whole blood loss 50-499 mL within 30 days or ≥ 499 mL within 56 days prior to first&#xD;
             dose of study drug.&#xD;
&#xD;
          -  Drug or alcohol abuse within 1 year prior to study entry&#xD;
&#xD;
          -  Steroid injections within 12 weeks prior to first dose of study drug&#xD;
&#xD;
          -  Live vaccine within 7 days prior to first dose of study drug&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Associate Director, Medical Affairs</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Canada, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>INC Research</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5V 2T3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>September 5, 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>November 6, 2012</last_update_submitted>
  <last_update_submitted_qc>November 6, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 8, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tacrolimus</keyword>
  <keyword>Advagraf®</keyword>
  <keyword>Prograf®</keyword>
  <keyword>Glomerular Filtration Rate</keyword>
  <keyword>Effective Renal Plasma Flow</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Pharmacodynamics</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/NCT01681134
org study id: FKC-016
nct id: NCT01681134
lead sponsor: 
has dmc: No
The purpose of the study is to evaluate the drug profiles (pharmacokinetics) and effects
      (pharmacodynamics) of Advagraf® and Prograf® on the kidneys.
This is a 2 Period study. In Period 1, subjects will be assigned randomly to receive
      Advagraf® or Prograf® administered once or twice daily, respectively, for a period of 10
      days. In Period 2, subjects will be converted from Advagraf® to Prograf® or from Prograf® to
      Advagraf® for 10 additional days of dosing. Dose adjustments will be made based on the
      monitoring of drug levels in blood.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Effective Renal Plasma Flow (ERPF)
time frame: up to Day 20
description: Estimated by aminohippurate sodium (PAH) clearance
measure: Glomerular Filtration Rate (GFR)
time frame: Pre-dose (Day -4), Day 10, Day 20
description: Estimated by sinistrin clearance
arm group label: Advagraf followed by Prograf
arm group type: Experimental
arm group label: Prograf followed by Advagraf
arm group type: Experimental
intervention type: Drug
intervention name: Advagraf®
description: oral
arm group label: Advagraf followed by Prograf
arm group label: Prograf followed by Advagraf
other name: tacrolimus XL, FK506E
intervention type: Drug
intervention name: Prograf®
description: oral
arm group label: Advagraf followed by Prograf
arm group label: Prograf followed by Advagraf
other name: tacrolimus, FK506
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Associate Director, Medical Affairs
role: Study Director
affiliation: Astellas Pharma Canada, Inc.
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Tacrolimus