<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/NCT01666951</url>
  </required_header>
  <id_info>
    <org_study_id>LCP-Tacro 2019</org_study_id>
    <nct_id>NCT01666951</nct_id>
  </id_info>
  <brief_title>Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant</brief_title>
  <official_title>Ph 2 Double-blind, Double-dummy, Multicenter, Prospective, Rand Study of PK of LCP-Tacro™ Tablets Once Daily, Compared to Prograf® Caps, Twice Daily, for Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Veloxis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Veloxis Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets&#xD;
      administered once-daily compared to Prograf capsules administered twice-daily after kidney&#xD;
      transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 2-arm , parallel group, prospective, double-blind, double-dummy,&#xD;
      multicenter,clinical trial to evaluate the pharmacokinetics of LCP-Tacro tablets once daily&#xD;
      in comparison to Prograf capsules twice-daily after kidney transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation</measure>
    <time_frame>1 days</time_frame>
    <description>The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation</measure>
    <time_frame>14 days</time_frame>
    <description>The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation</measure>
    <time_frame>28 days</time_frame>
    <description>The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation</measure>
    <time_frame>1 days</time_frame>
    <description>The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation</measure>
    <time_frame>14 days</time_frame>
    <description>The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation</measure>
    <time_frame>28 days</time_frame>
    <description>The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation</measure>
    <time_frame>1 days</time_frame>
    <description>The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation</measure>
    <time_frame>14 days</time_frame>
    <description>The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation</measure>
    <time_frame>28 days</time_frame>
    <description>The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation</measure>
    <time_frame>14 days</time_frame>
    <description>The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation</measure>
    <time_frame>28 days</time_frame>
    <description>The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.</measure>
    <time_frame>14 days</time_frame>
    <description>At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, &quot;nighttime dipping&quot;) between the two Groups at Days 14.</description>
  </other_outcome>
  <other_outcome>
    <measure>Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.</measure>
    <time_frame>28 days</time_frame>
    <description>At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, &quot;nighttime dipping&quot;) between the two Groups at Day 28.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.</measure>
    <time_frame>14 days</time_frame>
    <description>At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, &quot;nighttime dipping&quot;) between the two Groups at Days 14.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.</measure>
    <time_frame>28 days</time_frame>
    <description>At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, &quot;nighttime dipping&quot;) between the two Groups at Days 28.</description>
  </other_outcome>
  <other_outcome>
    <measure>Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.</measure>
    <time_frame>30 days</time_frame>
    <description>The efficacy is measured by the number of treatment failures defined as all-cause mortality, Graft Failure, Biopsy Proven Acute Rejection (BPAR) and Lost to follow up.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Renal Failure</condition>
  <arm_group>
    <arm_group_label>LCP-Tacro</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prograf</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LCP-Tacro tablets</intervention_name>
    <description>Tacrolimus</description>
    <arm_group_label>LCP-Tacro</arm_group_label>
    <other_name>Prograf</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prograf</intervention_name>
    <description>Tacrolimus</description>
    <arm_group_label>Prograf</arm_group_label>
    <other_name>Prograf Capsules twice daily</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Give written consent&#xD;
&#xD;
          -  Male and female subjects between the ages of 18 and 70 years, inclusive&#xD;
&#xD;
          -  Must be receiving primary or secondary renal allograft from a deceased donor or non-&#xD;
             HLA identical living donor&#xD;
&#xD;
          -  WOCBP must have a negative pregnancy test&#xD;
&#xD;
          -  Must have negative cross-match test and be ABO-compatible&#xD;
&#xD;
          -  Must be able to swallow tablets and capsules&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Recipients of any previous nonrenal or concurrent transplant&#xD;
&#xD;
          -  Have panel reactive antibody &gt;50%&#xD;
&#xD;
          -  Any condition that may affect study drug absorption BMI &lt;18 kg/m2 or &gt; 45 kg/m2&#xD;
&#xD;
          -  History of alcohol abuse with less than 6 months of sobriety&#xD;
&#xD;
          -  History of recreational drug abuse with less than 6 months of documented abstinence&#xD;
&#xD;
          -  Screening 12-lead ECG demonstrating CS abnormalities (including QTc prolongation)&#xD;
&#xD;
          -  WOCBP and are either pregnant, lactating, planning to become pregnant or with a&#xD;
             positive serum or urine pregnancy test&#xD;
&#xD;
          -  Subjects (male or female) with reproductive potential who are unwilling/unable to use&#xD;
             a double-barrier method&#xD;
&#xD;
          -  Oral temperature (prior to study drug dosing) of 38.0ºC or higher&#xD;
&#xD;
          -  CS active infections (eg, those requiring hospitalization, or as judged by the&#xD;
             Investigator)&#xD;
&#xD;
          -  Known hereditary immunodeficiency&#xD;
&#xD;
          -  Malignancies or with a history of malignancies (within the last 5 years) with the&#xD;
             exception of local, noninvasive, fully excised cutaneous basal cell carcinoma,&#xD;
             cutaneous squamous cell carcinoma, or cervical carcinoma in situ&#xD;
&#xD;
          -  Expect to receive within 2 months after randomization, or have received within 3&#xD;
             months prior to screening, any of the following: sirolimus, everolimus, belatacept, or&#xD;
             cyclophosphamide&#xD;
&#xD;
          -  Any psychiatric or medical condition that, in the Investigator's opinion, may put the&#xD;
             subject at significant risk, may confound the study results, or may interfere&#xD;
             significantly with the subject's participation in the study&#xD;
&#xD;
          -  Clinically symptomatic CHF or documented EJF of less than 45%&#xD;
&#xD;
          -  Significant COPD, pulmonary restrictive disease or significant pulmonary hypertension&#xD;
&#xD;
          -  Enrolled in another investigational drug or device study, or who are less than 30 days&#xD;
             since discontinuing&#xD;
&#xD;
          -  Laboratory variables that are abnormal (outside laboratory reference range) and CS&#xD;
&#xD;
          -  Positive results of any of the following serological tests: human immunodeficiency&#xD;
             virus (HIV)-1 antibody, hepatitis B virus (HBV) surface antigen (HBsAg),&#xD;
             anti-hepatitis B core antibody (HBcAb), and anti-hepatitis C virus (HCV) antibody (HCV&#xD;
             Ab)&#xD;
&#xD;
          -  Subjects who have had primary focal segmental glomerulosclerosis&#xD;
&#xD;
          -  Donor parameters must not include any of the following known conditions:&#xD;
&#xD;
        Donor with positive serological test result for HIV-1, HBV or HCV Donor with history of&#xD;
        malignant disease (current or historical) Cold ischemia time &gt;30 hours Non-heart-beating&#xD;
        donor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Polvino, MD</last_name>
    <role>Study Director</role>
    <affiliation>Veloxis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Investigative Site 000015</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigative Site 000012</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigative Site 00004</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigative Site 000002</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigative Site 000005</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536-0293</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigative Site 000009</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigative Site 000010</name>
      <address>
        <city>Livingston</city>
        <state>New Jersey</state>
        <zip>07039</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigative Site 000011</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigative Site 00006</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigative Site 00008</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigative Site 00003</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigative Site 000013</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigative Site 00001</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <results_first_submitted>May 19, 2015</results_first_submitted>
  <results_first_submitted_qc>June 30, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 7, 2015</results_first_posted>
  <last_update_submitted>June 30, 2015</last_update_submitted>
  <last_update_submitted_qc>June 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tacrolimus</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>LCP-Tacro</title>
          <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
        </group>
        <group group_id="P2">
          <title>Prograf</title>
          <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Not dosed</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The two patients that were randomized but not does (one in eacj treatment arm) are not included in the demographics</population>
      <group_list>
        <group group_id="B1">
          <title>LCP-Tacro</title>
          <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
        </group>
        <group group_id="B2">
          <title>Prograf</title>
          <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="34"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.5" spread="13.92"/>
                    <measurement group_id="B2" value="46.4" spread="11.49"/>
                    <measurement group_id="B3" value="49.0" spread="12.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.</title>
        <description>At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, &quot;nighttime dipping&quot;) between the two Groups at Days 14.</description>
        <time_frame>14 days</time_frame>
        <population>18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.</population>
        <group_list>
          <group group_id="O1">
            <title>LCP-Tacro</title>
            <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
          </group>
          <group group_id="O2">
            <title>Prograf</title>
            <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
          </group>
        </group_list>
        <measure>
          <title>Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.</title>
          <description>At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, &quot;nighttime dipping&quot;) between the two Groups at Days 14.</description>
          <population>18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Daytime SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.96" spread="10,311"/>
                    <measurement group_id="O2" value="131.54" spread="13.835"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nighttime SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.69" spread="9.147"/>
                    <measurement group_id="O2" value="133.38" spread="17.875"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overnight SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.80" spread="10.347"/>
                    <measurement group_id="O2" value="132.54" spread="18.127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.</title>
        <description>At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, &quot;nighttime dipping&quot;) between the two Groups at Day 28.</description>
        <time_frame>28 days</time_frame>
        <population>18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.</population>
        <group_list>
          <group group_id="O1">
            <title>LCP-Tacro</title>
            <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
          </group>
          <group group_id="O2">
            <title>Prograf</title>
            <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
          </group>
        </group_list>
        <measure>
          <title>Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.</title>
          <description>At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, &quot;nighttime dipping&quot;) between the two Groups at Day 28.</description>
          <population>18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Daytime SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139.05" spread="14.722"/>
                    <measurement group_id="O2" value="130.84" spread="15.754"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nighttime SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137.18" spread="13.283"/>
                    <measurement group_id="O2" value="129.09" spread="16.447"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overnight SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="136.11" spread="13.539"/>
                    <measurement group_id="O2" value="127.70" spread="16.599"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
        <description>The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.</description>
        <time_frame>1 days</time_frame>
        <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
        <group_list>
          <group group_id="O1">
            <title>LCP-Tacro</title>
            <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
          </group>
          <group group_id="O2">
            <title>Prograf</title>
            <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
          <description>The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.</description>
          <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
          <units>ng*hr/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="382.72" spread="233.84"/>
                    <measurement group_id="O2" value="147.82" spread="85.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
        <description>The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.</description>
        <time_frame>14 days</time_frame>
        <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
        <group_list>
          <group group_id="O1">
            <title>LCP-Tacro</title>
            <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
          </group>
          <group group_id="O2">
            <title>Prograf</title>
            <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
          <description>The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.</description>
          <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
          <units>ng*hr/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="371.43" spread="133.85"/>
                    <measurement group_id="O2" value="244.63" spread="66.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
        <description>The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.</description>
        <time_frame>28 days</time_frame>
        <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
        <group_list>
          <group group_id="O1">
            <title>LCP-Tacro</title>
            <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
          </group>
          <group group_id="O2">
            <title>Prograf</title>
            <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
          <description>The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.</description>
          <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
          <units>ng*hr/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="357.39" spread="146.64"/>
                    <measurement group_id="O2" value="205.79" spread="36.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
        <description>The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.</description>
        <time_frame>1 days</time_frame>
        <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
        <group_list>
          <group group_id="O1">
            <title>LCP-Tacro</title>
            <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
          </group>
          <group group_id="O2">
            <title>Prograf</title>
            <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
          <description>The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.</description>
          <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cmax</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.68" spread="20.51"/>
                    <measurement group_id="O2" value="12.97" spread="7.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.32" spread="8.89"/>
                    <measurement group_id="O2" value="5.72" spread="5.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
        <description>The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.</description>
        <time_frame>14 days</time_frame>
        <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
        <group_list>
          <group group_id="O1">
            <title>LCP-Tacro</title>
            <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
          </group>
          <group group_id="O2">
            <title>Prograf</title>
            <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
          <description>The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.</description>
          <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cmax</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.08" spread="14.27"/>
                    <measurement group_id="O2" value="18.98" spread="6.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.11" spread="2.86"/>
                    <measurement group_id="O2" value="7.54" spread="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
        <description>The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.</description>
        <time_frame>28 days</time_frame>
        <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
        <group_list>
          <group group_id="O1">
            <title>LCP-Tacro</title>
            <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
          </group>
          <group group_id="O2">
            <title>Prograf</title>
            <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
          <description>The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.</description>
          <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cmax</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.51" spread="18.74"/>
                    <measurement group_id="O2" value="17.38" spread="4.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.31" spread="3.44"/>
                    <measurement group_id="O2" value="6.75" spread="2.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
        <description>The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.</description>
        <time_frame>1 days</time_frame>
        <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
        <group_list>
          <group group_id="O1">
            <title>LCP-Tacro</title>
            <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
          </group>
          <group group_id="O2">
            <title>Prograf</title>
            <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
          <description>The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.</description>
          <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.26" spread="7.49"/>
                    <measurement group_id="O2" value="7.39" spread="6.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
        <description>The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.</description>
        <time_frame>14 days</time_frame>
        <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
        <group_list>
          <group group_id="O1">
            <title>LCP-Tacro</title>
            <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
          </group>
          <group group_id="O2">
            <title>Prograf</title>
            <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
          <description>The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.</description>
          <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.03" spread="5.69"/>
                    <measurement group_id="O2" value="5.03" spread="5.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
        <description>The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.</description>
        <time_frame>28 days</time_frame>
        <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
        <group_list>
          <group group_id="O1">
            <title>LCP-Tacro</title>
            <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
          </group>
          <group group_id="O2">
            <title>Prograf</title>
            <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
          <description>The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.</description>
          <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.69" spread="4.11"/>
                    <measurement group_id="O2" value="7.69" spread="6.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
        <description>The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.</description>
        <time_frame>14 days</time_frame>
        <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
        <group_list>
          <group group_id="O1">
            <title>LCP-Tacro</title>
            <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
          </group>
          <group group_id="O2">
            <title>Prograf</title>
            <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
          <description>The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.</description>
          <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
          <units>Percentage of fluctuation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126.86" spread="57.65"/>
                    <measurement group_id="O2" value="114.73" spread="52.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
        <description>The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.</description>
        <time_frame>28 days</time_frame>
        <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
        <group_list>
          <group group_id="O1">
            <title>LCP-Tacro</title>
            <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
          </group>
          <group group_id="O2">
            <title>Prograf</title>
            <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation</title>
          <description>The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.</description>
          <population>The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.</population>
          <units>Percentage of fluctuation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144.78" spread="84.63"/>
                    <measurement group_id="O2" value="131.4" spread="75.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.</title>
        <description>At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, &quot;nighttime dipping&quot;) between the two Groups at Days 14.</description>
        <time_frame>14 days</time_frame>
        <population>18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.</population>
        <group_list>
          <group group_id="O1">
            <title>LCP-Tacro</title>
            <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
          </group>
          <group group_id="O2">
            <title>Prograf</title>
            <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.</title>
          <description>At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, &quot;nighttime dipping&quot;) between the two Groups at Days 14.</description>
          <population>18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Night:Day ratio SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.99" spread="0.035"/>
                    <measurement group_id="O2" value="1.01" spread="0.057"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overnight:Day Ratio SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="0.053"/>
                    <measurement group_id="O2" value="1.01" spread="0.057"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.</title>
        <description>At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, &quot;nighttime dipping&quot;) between the two Groups at Days 28.</description>
        <time_frame>28 days</time_frame>
        <population>18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.</population>
        <group_list>
          <group group_id="O1">
            <title>LCP-Tacro</title>
            <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
          </group>
          <group group_id="O2">
            <title>Prograf</title>
            <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.</title>
          <description>At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, &quot;nighttime dipping&quot;) between the two Groups at Days 28.</description>
          <population>18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Night:Day ratio SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.99" spread="0.035"/>
                    <measurement group_id="O2" value="0.98" spread="0.067"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overnight:Day Ratio SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.99" spread="0.064"/>
                    <measurement group_id="O2" value="0.98" spread="0.067"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.</title>
        <description>The efficacy is measured by the number of treatment failures defined as all-cause mortality, Graft Failure, Biopsy Proven Acute Rejection (BPAR) and Lost to follow up.</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>LCP-Tacro</title>
            <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
          </group>
          <group group_id="O2">
            <title>Prograf</title>
            <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.</title>
          <description>The efficacy is measured by the number of treatment failures defined as all-cause mortality, Graft Failure, Biopsy Proven Acute Rejection (BPAR) and Lost to follow up.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All-cause mortality</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Graft Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BPAR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lost to follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>LCP-Tacro</title>
          <description>LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)&#xD;
LCP-Tacro tablets: Tacrolimus</description>
        </group>
        <group group_id="E2">
          <title>Prograf</title>
          <description>Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)&#xD;
Prograf: Tacrolimus</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Atrial Fibrilation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Kidney transplant rejection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pelvic Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal INjury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Atrial fibrilation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Sinus Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperparathyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="17"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site realted reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Exercise tolerance decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Kidney transplant rejection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Oral Candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pelvic abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Vulvovaginal myotic infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Incision site erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Incision site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Incision site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Seroma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Drug level increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Oxygen saturation decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Polyomavirus test positive</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Vitamin D decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hypovitaminosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Vimatin D deficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lung neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Thyroid neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Perinephric effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pyelocaliectasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Renal injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Penile pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Christina Sylvest</name_or_title>
      <organization>Veloxis Pharmaceuticals</organization>
      <phone>+4520553877</phone>
      <email>csy@veloxis.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01666951
org study id: LCP-Tacro 2019
nct id: NCT01666951
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets
      administered once-daily compared to Prograf capsules administered twice-daily after kidney
      transplantation.
This is a 2-arm , parallel group, prospective, double-blind, double-dummy,
      multicenter,clinical trial to evaluate the pharmacokinetics of LCP-Tacro tablets once daily
      in comparison to Prograf capsules twice-daily after kidney transplantation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
time frame: 1 days
description: The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.
measure: Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
time frame: 14 days
description: The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.
measure: Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
time frame: 28 days
description: The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.
measure: Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
time frame: 1 days
description: The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.
measure: Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
time frame: 14 days
description: The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.
measure: Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
time frame: 28 days
description: The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.
measure: Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
time frame: 1 days
description: The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.
measure: Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
time frame: 14 days
description: The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.
measure: Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
time frame: 28 days
description: The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.
measure: Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
time frame: 14 days
description: The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.
measure: Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
time frame: 28 days
description: The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.
measure: Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.
time frame: 14 days
description: At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.
measure: Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.
time frame: 28 days
description: At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Day 28.
measure: Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.
time frame: 14 days
description: At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.
measure: Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.
time frame: 28 days
description: At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 28.
measure: Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.
time frame: 30 days
description: The efficacy is measured by the number of treatment failures defined as all-cause mortality, Graft Failure, Biopsy Proven Acute Rejection (BPAR) and Lost to follow up.
arm group label: LCP-Tacro
arm group type: Experimental
description: LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
arm group label: Prograf
arm group type: Active Comparator
description: Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
intervention type: Drug
intervention name: LCP-Tacro tablets
description: Tacrolimus
arm group label: LCP-Tacro
other name: Prograf
intervention type: Drug
intervention name: Prograf
description: Tacrolimus
arm group label: Prograf
other name: Prograf Capsules twice daily
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: William Polvino, MD
role: Study Director
affiliation: Veloxis Pharmaceuticals
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Tacrolimus
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 