<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/NCT01698541</url>
  </required_header>
  <id_info>
    <org_study_id>GenTac-12</org_study_id>
    <nct_id>NCT01698541</nct_id>
    <nct_alias>NCT01798758</nct_alias>
  </id_info>
  <brief_title>Generic Tacrolimus in the Elderly - Prograf® vs Tacni®</brief_title>
  <acronym>GenTac</acronym>
  <official_title>Generic Tacrolimus in the Elderly - Prograf® vs Tacni®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oslo School of Pharmacy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oslo School of Pharmacy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as&#xD;
      comparator, in elderly (&gt;60 yr) renal transplant recipients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      12-hour pharmacokinetic investigations performed on each formulation in each patient at&#xD;
      steady-state. Patients will be randomized with regards to which formulation to start with.&#xD;
      1-2 weeks between each PK investigation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bioequivalence</measure>
    <time_frame>10 weeks</time_frame>
    <description>Bioequivalence will be assessed at steady-state by comparing both AUC(0-12) and Cmax ratios for generic:original-ratios and applying the stricter 90-111% bioequivalence criteria.&#xD;
AUC(0-12) will be assessed by trapezoidal rule and Cmax will be the highest actually measured concentration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Population model validation</measure>
    <time_frame>10 weeks</time_frame>
    <description>Use these new patient data to verify previously developed population pharmacokinetic model for tacrolimus.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Tacni</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tacrolimus administered as generic formulation Tacni in accordance with standard protocol at the transplant center</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prograf</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tacrolimus administered as Prograf in according to standard protocol at the transplant center</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tacrolimus</intervention_name>
    <description>Tested generic</description>
    <arm_group_label>Prograf</arm_group_label>
    <arm_group_label>Tacni</arm_group_label>
    <other_name>Tacrolimus formualted as the generic Tacni</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tacrolimus</intervention_name>
    <description>Original formulation used as comparator</description>
    <arm_group_label>Prograf</arm_group_label>
    <arm_group_label>Tacni</arm_group_label>
    <other_name>Tacrolimus formualted as the original Prograf</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Renal transplant recipients that will receive Tac as part of their immunosuppressive&#xD;
             therapy.&#xD;
&#xD;
          -  Recipients 60 years of age or older.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus (WHO criteria).&#xD;
&#xD;
          -  Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepin,&#xD;
             fluconazole, ketoconazole, voriconazole, erythromycin, clarithromycin.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anders Åsberg, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo University Hospital, Rikshospitalet</name>
      <address>
        <city>Oslo</city>
        <zip>0027</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>December 2, 2014</last_update_submitted>
  <last_update_submitted_qc>December 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo School of Pharmacy</investigator_affiliation>
    <investigator_full_name>Anders Åsberg</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Renal</keyword>
  <keyword>Transplantation</keyword>
  <keyword>Elderly</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <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/NCT01698541
org study id: GenTac-12
nct id: NCT01698541
nct alias: NCT01798758
lead sponsor: 
collaborator: 
has dmc: No
Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as
      comparator, in elderly (>60 yr) renal transplant recipients
12-hour pharmacokinetic investigations performed on each formulation in each patient at
      steady-state. Patients will be randomized with regards to which formulation to start with.
      1-2 weeks between each PK investigation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bioequivalence
time frame: 10 weeks
description: Bioequivalence will be assessed at steady-state by comparing both AUC(0-12) and Cmax ratios for generic:original-ratios and applying the stricter 90-111% bioequivalence criteria.
AUC(0-12) will be assessed by trapezoidal rule and Cmax will be the highest actually measured concentration.
measure: Population model validation
time frame: 10 weeks
description: Use these new patient data to verify previously developed population pharmacokinetic model for tacrolimus.
arm group label: Tacni
arm group type: Experimental
description: Tacrolimus administered as generic formulation Tacni in accordance with standard protocol at the transplant center
arm group label: Prograf
arm group type: Active Comparator
description: Tacrolimus administered as Prograf in according to standard protocol at the transplant center
intervention type: Drug
intervention name: Tacrolimus
description: Tested generic
arm group label: Prograf
arm group label: Tacni
other name: Tacrolimus formualted as the generic Tacni
intervention type: Drug
intervention name: Tacrolimus
description: Original formulation used as comparator
arm group label: Prograf
arm group label: Tacni
other name: Tacrolimus formualted as the original Prograf
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Anders Åsberg, PhD
role: Study Chair
affiliation: University of Oslo
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: University of Oslo School of Pharmacy
investigator full name: Anders Åsberg
investigator title: Professor
mesh term: Kidney Failure, Chronic
mesh term: Tacrolimus