<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/NCT03762473</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300001068</org_study_id>
    <nct_id>NCT03762473</nct_id>
  </id_info>
  <brief_title>Conversion to Envarsus Post Kidney Transplant Protects Against BK Infection</brief_title>
  <official_title>Conversion From Tacrolimus to Envarsus in Rapid Metabolizers Post Kidney Transplant Protects Against BK Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess if the use of Envarsus in place of&#xD;
      Tacrolimus-immediate release (IR) in rapid metabolizers post kidney transplant will reduce&#xD;
      incidence of BK infection. Efficacy evaluations will include measurement of urine and serum&#xD;
      BK values at specified time points and review of any biopsy for BK virus nephropathy.&#xD;
      Incidence of rejection, graft failure, and graft dysfunction will also be measured at&#xD;
      specified time points.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a single center prospective case control study. The investigators expect 40% of&#xD;
      patients will develop BK viruria, 20% BK viremia, 5% BK viral nephropathy (BKVN). Patients&#xD;
      will be managed using standard of care for the investigator's center (thymoglobulin&#xD;
      induction, tacrolimus/mycophenolate/prednisone). Target tacrolimus level is 8-12 ng/mL for&#xD;
      the first 6 months post transplant and 6-9 ng/mL thereafter. BK urine/serum is monitored at&#xD;
      1, 3, 6, 9, 2 months post transplant. A population of 100 patients is calculated to show&#xD;
      significant difference for p value &lt; 0.05.&#xD;
&#xD;
      Population:&#xD;
&#xD;
      Study Group: Post transplant patients (kidney transplant alone) with standard of care&#xD;
      immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK&#xD;
      screening at post-transplant month 1, who have a tacrolimus concentration/dose of &lt; 1 and a&#xD;
      steady state therapeutic level will be eligible. Patients who consent will be converted to&#xD;
      Envarsus at 20% reduction in tacrolimus dose.&#xD;
&#xD;
      Control Group: Post transplant patients (kidney transplant alone performed between 10-2016&#xD;
      and time of enrollment) with standard of care immunosuppression, no prior rejection, prior BK&#xD;
      or opportunistic infection, whom had a negative BK screening at post-transplant month 1 and&#xD;
      tacrolimus concentration/dose of &lt; 1 at post-transplant month 1, and BK data available for&#xD;
      months 2, 3, 6, 9,12 post transplant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 9, 2019</start_date>
  <completion_date type="Actual">March 16, 2022</completion_date>
  <primary_completion_date type="Actual">March 16, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participants Will Experience Less BK Infection Episodes Based on Viruria Results.</measure>
    <time_frame>From baseline to 30 days</time_frame>
    <description>The evidence of BK virus infection will be measured by viruria &gt;500 copies.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants Will Experience Less BK Infection Episodes Based on Viremia Results.</measure>
    <time_frame>From baseline to 30 days</time_frame>
    <description>The evidence of BK virus infection will be measured by viremia &gt;500 copies.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.</measure>
    <time_frame>From baseline to 30 days</time_frame>
    <description>The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants Will Experience Less BK Infection Episodes Based on Viruria Results.</measure>
    <time_frame>From baseline to 120 days</time_frame>
    <description>The evidence of BK virus infection will be measured by viruria &gt;500 copies.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants Will Experience Less BK Infection Episodes Based on Viremia Results.</measure>
    <time_frame>From baseline to 120 days</time_frame>
    <description>The evidence of BK virus infection will be measured by viremia &gt;500 copies.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.</measure>
    <time_frame>From baseline to 120 days</time_frame>
    <description>The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants Will Experience Less BK Infection Episodes Based on Viruria Results.</measure>
    <time_frame>From baseline to 210 days</time_frame>
    <description>The evidence of BK virus infection will be measured by viruria &gt;500 copies.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants Will Experience Less BK Infection Episodes Based on Viremia Results.</measure>
    <time_frame>From baseline to 210 days</time_frame>
    <description>The evidence of BK virus infection will be measured by viremia &gt;500 copies.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.</measure>
    <time_frame>From baseline to 210 days</time_frame>
    <description>The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Viruria &gt;500 Copies</measure>
    <time_frame>at 300 days</time_frame>
    <description>Participants will experience less BK infection episodes based on viruria reported with &gt;500 copies.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants Will Experience Less BK Infection Episodes Based on Viremia Results.</measure>
    <time_frame>at 300 days</time_frame>
    <description>The evidence of BK virus infection will be measured by viremia &gt;500 copies.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.</measure>
    <time_frame>at 300 days</time_frame>
    <description>The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.</measure>
    <time_frame>From baseline to 30 days</time_frame>
    <description>Safety will be assessed for all Grade 3 or higher infection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.</measure>
    <time_frame>From baseline to 120 days</time_frame>
    <description>Safety will be assessed for all Grade 3 or higher infection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.</measure>
    <time_frame>From baseline to 210 days</time_frame>
    <description>Safety will be assessed for all Grade 3 or higher infection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.</measure>
    <time_frame>at 300 days</time_frame>
    <description>Safety will be assessed for all Grade 3 or higher infection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.</measure>
    <time_frame>From baseline to 30 days</time_frame>
    <description>This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated glomerular filtration rate (GFR) and proteinuria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.</measure>
    <time_frame>From baseline to 120 days</time_frame>
    <description>This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.</measure>
    <time_frame>From baseline to 210 days</time_frame>
    <description>This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.</measure>
    <time_frame>at 300 days</time_frame>
    <description>This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Renal Transplant Infection</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Study Group</intervention_name>
    <description>Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
    <arm_group_label>Study Group</arm_group_label>
    <other_name>tacrolimus extended-release tablets</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Tacrolimus</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years of age at the time of study entry&#xD;
&#xD;
          -  Recipient of a deceased or living donor kidney transplantation&#xD;
&#xD;
          -  Maintenance immunosuppression consisting of tacrolimus/ mycophenolate mofetil&#xD;
             (MMF)/mycophenolic acid (MPA) (≥1000 mg/720 mg daily) ± prednisone (≤10 mg/day)&#xD;
&#xD;
          -  Patient is less than or at 8 weeks post transplant with a negative serum BK Virus&#xD;
             screen at 3-4 weeks post transplant&#xD;
&#xD;
          -  Patient has a tacrolimus drug dose/concentration of &gt; 1 with therapeutic tacrolimus&#xD;
             levels.&#xD;
&#xD;
          -  Women of childbearing potential defined as all women physiologically capable of&#xD;
             becoming pregnant, must have reviewed Mycophenolate Risk Evaluation and Mitigation&#xD;
             Strategy (REMS) and have a negative pregnancy test upon study entry.&#xD;
&#xD;
          -  Female (and male) subjects with reproductive potential must agree to use a highly&#xD;
             effective method of birth control for the duration of the study. Please note that&#xD;
             according to the US product information for MMF/MPA, two reliable forms of&#xD;
             contraception must be used simultaneously unless female sterilization, male&#xD;
             sterilization, post-menopausal status or total abstinence is the chosen method.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability or unwillingness of a patient to give written informed consent or comply&#xD;
             with study protocol&#xD;
&#xD;
          -  History of graft loss from acute rejection within 1 year after any previous kidney&#xD;
             transplant&#xD;
&#xD;
          -  History of previous liver, heart, pancreas, or lung transplant&#xD;
&#xD;
          -  History of cellular rejection of current allograft prior to enrollment.&#xD;
&#xD;
          -  Serum BK virus ≥500 copies/ml by polymerase chain reaction (PCR) at the time of study&#xD;
             entry&#xD;
&#xD;
          -  Female subjects who are pregnant or breast feeding&#xD;
&#xD;
          -  Participation in any other studies with investigational drugs or regimens in the&#xD;
             preceding year from the time of study entry&#xD;
&#xD;
          -  Any condition or prior treatment which, in the opinion of the investigator, precludes&#xD;
             study participation&#xD;
&#xD;
          -  Patients requiring the use of azathioprine or a class of drugs that inhibit the&#xD;
             mammalian target of rapamycin (mTOR inhibitors)&#xD;
&#xD;
          -  Patients with active peptic ulcer disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Graham C Towns, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <results_first_submitted>January 18, 2023</results_first_submitted>
  <results_first_submitted_qc>July 5, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 27, 2023</results_first_posted>
  <last_update_submitted>July 5, 2023</last_update_submitted>
  <last_update_submitted_qc>July 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Graham C. Towns</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Envarsus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tacrolimus</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 5, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03762473/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Study Group</title>
          <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Study Group</title>
          <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</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="43"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="88"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>the patient who died was not included in the statistics</population>
          <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="40"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.19" lower_limit="26" upper_limit="68"/>
                    <measurement group_id="B2" value="50.19" lower_limit="26" upper_limit="68"/>
                    <measurement group_id="B3" value="50.19" lower_limit="26" upper_limit="68"/>
                  </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="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="61"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>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="40"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                  </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="43"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Participants Will Experience Less BK Infection Episodes Based on Viruria Results.</title>
        <description>The evidence of BK virus infection will be measured by viruria &gt;500 copies.</description>
        <time_frame>From baseline to 30 days</time_frame>
        <population>data not gathered for this time period.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Will Experience Less BK Infection Episodes Based on Viruria Results.</title>
          <description>The evidence of BK virus infection will be measured by viruria &gt;500 copies.</description>
          <population>data not gathered for this time period.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participants Will Experience Less BK Infection Episodes Based on Viremia Results.</title>
        <description>The evidence of BK virus infection will be measured by viremia &gt;500 copies.</description>
        <time_frame>From baseline to 30 days</time_frame>
        <population>data not gathered for this time period</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Will Experience Less BK Infection Episodes Based on Viremia Results.</title>
          <description>The evidence of BK virus infection will be measured by viremia &gt;500 copies.</description>
          <population>data not gathered for this time period</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.</title>
        <description>The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).</description>
        <time_frame>From baseline to 30 days</time_frame>
        <population>data was not gathered at this time period</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.</title>
          <description>The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).</description>
          <population>data was not gathered at this time period</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participants Will Experience Less BK Infection Episodes Based on Viruria Results.</title>
        <description>The evidence of BK virus infection will be measured by viruria &gt;500 copies.</description>
        <time_frame>From baseline to 120 days</time_frame>
        <population>no data was collected for this time period.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Will Experience Less BK Infection Episodes Based on Viruria Results.</title>
          <description>The evidence of BK virus infection will be measured by viruria &gt;500 copies.</description>
          <population>no data was collected for this time period.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participants Will Experience Less BK Infection Episodes Based on Viremia Results.</title>
        <description>The evidence of BK virus infection will be measured by viremia &gt;500 copies.</description>
        <time_frame>From baseline to 120 days</time_frame>
        <population>data was not collected for this time period.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Will Experience Less BK Infection Episodes Based on Viremia Results.</title>
          <description>The evidence of BK virus infection will be measured by viremia &gt;500 copies.</description>
          <population>data was not collected for this time period.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.</title>
        <description>The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).</description>
        <time_frame>From baseline to 120 days</time_frame>
        <population>data was not collected for this time period.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.</title>
          <description>The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).</description>
          <population>data was not collected for this time period.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participants Will Experience Less BK Infection Episodes Based on Viruria Results.</title>
        <description>The evidence of BK virus infection will be measured by viruria &gt;500 copies.</description>
        <time_frame>From baseline to 210 days</time_frame>
        <population>data was not collected for this time period.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Will Experience Less BK Infection Episodes Based on Viruria Results.</title>
          <description>The evidence of BK virus infection will be measured by viruria &gt;500 copies.</description>
          <population>data was not collected for this time period.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participants Will Experience Less BK Infection Episodes Based on Viremia Results.</title>
        <description>The evidence of BK virus infection will be measured by viremia &gt;500 copies.</description>
        <time_frame>From baseline to 210 days</time_frame>
        <population>data was not collected for this time period.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Will Experience Less BK Infection Episodes Based on Viremia Results.</title>
          <description>The evidence of BK virus infection will be measured by viremia &gt;500 copies.</description>
          <population>data was not collected for this time period.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.</title>
        <description>The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).</description>
        <time_frame>From baseline to 210 days</time_frame>
        <population>data was not collected for this time period.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.</title>
          <description>The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).</description>
          <population>data was not collected for this time period.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Viruria &gt;500 Copies</title>
        <description>Participants will experience less BK infection episodes based on viruria reported with &gt;500 copies.</description>
        <time_frame>at 300 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Viruria &gt;500 Copies</title>
          <description>Participants will experience less BK infection episodes based on viruria reported with &gt;500 copies.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participants Will Experience Less BK Infection Episodes Based on Viremia Results.</title>
        <description>The evidence of BK virus infection will be measured by viremia &gt;500 copies.</description>
        <time_frame>at 300 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Will Experience Less BK Infection Episodes Based on Viremia Results.</title>
          <description>The evidence of BK virus infection will be measured by viremia &gt;500 copies.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.</title>
        <description>The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).</description>
        <time_frame>at 300 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.</title>
          <description>The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.</title>
        <description>Safety will be assessed for all Grade 3 or higher infection</description>
        <time_frame>From baseline to 30 days</time_frame>
        <population>data was not collected for this time period.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.</title>
          <description>Safety will be assessed for all Grade 3 or higher infection</description>
          <population>data was not collected for this time period.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.</title>
        <description>Safety will be assessed for all Grade 3 or higher infection</description>
        <time_frame>From baseline to 120 days</time_frame>
        <population>data was not collected for this time period.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.</title>
          <description>Safety will be assessed for all Grade 3 or higher infection</description>
          <population>data was not collected for this time period.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.</title>
        <description>Safety will be assessed for all Grade 3 or higher infection</description>
        <time_frame>From baseline to 210 days</time_frame>
        <population>data was not collected for this time period.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.</title>
          <description>Safety will be assessed for all Grade 3 or higher infection</description>
          <population>data was not collected for this time period.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.</title>
        <description>Safety will be assessed for all Grade 3 or higher infection</description>
        <time_frame>at 300 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.</title>
          <description>Safety will be assessed for all Grade 3 or higher infection</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.</title>
        <description>This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated glomerular filtration rate (GFR) and proteinuria</description>
        <time_frame>From baseline to 30 days</time_frame>
        <population>data was not collected for this time period.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.</title>
          <description>This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated glomerular filtration rate (GFR) and proteinuria</description>
          <population>data was not collected for this time period.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.</title>
        <description>This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria</description>
        <time_frame>From baseline to 120 days</time_frame>
        <population>data was not collected for this time period.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.</title>
          <description>This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria</description>
          <population>data was not collected for this time period.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.</title>
        <description>This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria</description>
        <time_frame>From baseline to 210 days</time_frame>
        <population>data was not collected for this time period.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.</title>
          <description>This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria</description>
          <population>data was not collected for this time period.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.</title>
        <description>This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria</description>
        <time_frame>at 300 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.</title>
          <description>This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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>at 300 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Study Group</title>
          <description>Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of &lt; 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.&#xD;
Study Group: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.&#xD;
Control Group: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of &lt; 1 at month 1, and BK data available and month 2,3, 6,9,12.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </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>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Graham Towns, MD</name_or_title>
      <organization>University of Alabama at Birmingham</organization>
      <phone>(205)934-1801</phone>
      <email>gtowns@uabmc.edu</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/NCT03762473
org study id: IRB-300001068
nct id: NCT03762473
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to assess if the use of Envarsus in place of
      Tacrolimus-immediate release (IR) in rapid metabolizers post kidney transplant will reduce
      incidence of BK infection. Efficacy evaluations will include measurement of urine and serum
      BK values at specified time points and review of any biopsy for BK virus nephropathy.
      Incidence of rejection, graft failure, and graft dysfunction will also be measured at
      specified time points.
This will be a single center prospective case control study. The investigators expect 40% of
      patients will develop BK viruria, 20% BK viremia, 5% BK viral nephropathy (BKVN). Patients
      will be managed using standard of care for the investigator's center (thymoglobulin
      induction, tacrolimus/mycophenolate/prednisone). Target tacrolimus level is 8-12 ng/mL for
      the first 6 months post transplant and 6-9 ng/mL thereafter. BK urine/serum is monitored at
      1, 3, 6, 9, 2 months post transplant. A population of 100 patients is calculated to show
      significant difference for p value < 0.05.

      Population:

      Study Group: Post transplant patients (kidney transplant alone) with standard of care
      immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK
      screening at post-transplant month 1, who have a tacrolimus concentration/dose of < 1 and a
      steady state therapeutic level will be eligible. Patients who consent will be converted to
      Envarsus at 20% reduction in tacrolimus dose.

      Control Group: Post transplant patients (kidney transplant alone performed between 10-2016
      and time of enrollment) with standard of care immunosuppression, no prior rejection, prior BK
      or opportunistic infection, whom had a negative BK screening at post-transplant month 1 and
      tacrolimus concentration/dose of < 1 at post-transplant month 1, and BK data available for
      months 2, 3, 6, 9,12 post transplant.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Participants Will Experience Less BK Infection Episodes Based on Viruria Results.
time frame: From baseline to 30 days
description: The evidence of BK virus infection will be measured by viruria >500 copies.
measure: Participants Will Experience Less BK Infection Episodes Based on Viremia Results.
time frame: From baseline to 30 days
description: The evidence of BK virus infection will be measured by viremia >500 copies.
measure: Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.
time frame: From baseline to 30 days
description: The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).
measure: Participants Will Experience Less BK Infection Episodes Based on Viruria Results.
time frame: From baseline to 120 days
description: The evidence of BK virus infection will be measured by viruria >500 copies.
measure: Participants Will Experience Less BK Infection Episodes Based on Viremia Results.
time frame: From baseline to 120 days
description: The evidence of BK virus infection will be measured by viremia >500 copies.
measure: Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.
time frame: From baseline to 120 days
description: The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).
measure: Participants Will Experience Less BK Infection Episodes Based on Viruria Results.
time frame: From baseline to 210 days
description: The evidence of BK virus infection will be measured by viruria >500 copies.
measure: Participants Will Experience Less BK Infection Episodes Based on Viremia Results.
time frame: From baseline to 210 days
description: The evidence of BK virus infection will be measured by viremia >500 copies.
measure: Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.
time frame: From baseline to 210 days
description: The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).
measure: Number of Participants With Viruria >500 Copies
time frame: at 300 days
description: Participants will experience less BK infection episodes based on viruria reported with >500 copies.
measure: Participants Will Experience Less BK Infection Episodes Based on Viremia Results.
time frame: at 300 days
description: The evidence of BK virus infection will be measured by viremia >500 copies.
measure: Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.
time frame: at 300 days
description: The evidence of BK virus infection will be measured by nephropathy as defined by Banff classification (sv 40 positivity with or without tubulitis or if/ta).
measure: Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.
time frame: From baseline to 30 days
description: Safety will be assessed for all Grade 3 or higher infection
measure: Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.
time frame: From baseline to 120 days
description: Safety will be assessed for all Grade 3 or higher infection
measure: Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.
time frame: From baseline to 210 days
description: Safety will be assessed for all Grade 3 or higher infection
measure: Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.
time frame: at 300 days
description: Safety will be assessed for all Grade 3 or higher infection
measure: Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.
time frame: From baseline to 30 days
description: This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated glomerular filtration rate (GFR) and proteinuria
measure: Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.
time frame: From baseline to 120 days
description: This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria
measure: Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.
time frame: From baseline to 210 days
description: This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria
measure: Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.
time frame: at 300 days
description: This assessment will include incidence of rejection, graft failure, graft dysfunction as defined by a 15% decrease in estimated GFR and proteinuria
arm group label: Study Group
arm group type: Experimental
description: Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of < 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.
arm group label: Control Group
arm group type: Active Comparator
description: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of < 1 at month 1, and BK data available and month 2,3, 6,9,12.
intervention type: Drug
intervention name: Study Group
description: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.
arm group label: Study Group
other name: tacrolimus extended-release tablets
intervention type: Drug
intervention name: Control Group
description: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of < 1 at month 1, and BK data available and month 2,3, 6,9,12.
arm group label: Control Group
other name: Tacrolimus
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Graham C Towns, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Graham C. Towns
investigator title: Principal Investigator
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Tacrolimus
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 