<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/NCT01672957</url>
  </required_header>
  <id_info>
    <org_study_id>ML27844</org_study_id>
    <nct_id>NCT01672957</nct_id>
  </id_info>
  <brief_title>An Observational Study on Renal Function in Kidney Transplant Participants on Immunosuppressive Therapy Containing Mycophenolate Mofetil</brief_title>
  <acronym>ORANGE</acronym>
  <official_title>Non-interventional Clinical Study With Target of Kidney Function Follow-up in Routine Clinical Practice on De Novo Kidney Transplant Recipients Who Are on CellCept Immunosuppressive Combination Therapy in Routine Clinical Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This observational study will evaluate renal function in participants who underwent renal&#xD;
      allograft transplantation and are started on combined immunosuppressive treatment containing&#xD;
      mycophenolate mofetil (CellCept). Eligible participants will be followed for 12 months&#xD;
      following transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participant sampling method used in the Orange study was consecutive sampling, a&#xD;
      non-probability sampling method where each participant meeting the study's inclusion and&#xD;
      exclusion criteria is selected and enrolled in the study until the pre-set sample size is&#xD;
      achieved.&#xD;
&#xD;
      Thus, in the Orange study de novo kidney transplanted participants, who were on mycophenolate&#xD;
      mofetil immunosuppressive combination therapy in routine clinical practice, were selected in&#xD;
      a consecutive manner (a non-probability sampling method) if they met the inclusion/exclusion&#xD;
      criteria until 128 participants were recruited to the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Creatinine Clearance at 1 Month After Transplantation</measure>
    <time_frame>Month 1</time_frame>
    <description>Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Creatinine Clearance at Month 6 After Transplantation</measure>
    <time_frame>Month 6</time_frame>
    <description>Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Creatinine Clearance at Month 12 After Transplantation</measure>
    <time_frame>Month 12</time_frame>
    <description>Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glomerular Filtration Rate (GFR) at Month 1 After Transplantation</measure>
    <time_frame>Month 1</time_frame>
    <description>GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (&gt;) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (&lt;) 15 mL/min indicates kidney failure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GFR at Month 6 After Transplantation</measure>
    <time_frame>Month 6</time_frame>
    <description>GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is &gt; 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR &lt; 15 mL/min indicates kidney failure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GFR at Month 12 After Transplantation</measure>
    <time_frame>Month 12</time_frame>
    <description>GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is &gt; 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR &lt; 15 mL/min indicates kidney failure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Dose of Mycophenolate Mofetil</measure>
    <time_frame>Baseline, Months 1, 6, and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil</measure>
    <time_frame>Baseline, Months 1, 6, and 12</time_frame>
    <description>Participants could have received more than one other immunosuppressive agents, at the discretion of treating physician. Percentage of participants who received 1 other immunosuppressive agent, 2 other immunosuppressive agents, and 3 other immunosuppressive agents are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Acute Rejection</measure>
    <time_frame>Baseline to Month 1, Months 2 to 6, Months 7 to 12</time_frame>
    <description>Percentage of participants who experienced acute rejection within 1 month of transplantation, Month 2 to Month 6 after transplantation, Month 7 to Month 12 after transplantation are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Graft Survival</measure>
    <time_frame>Months 1, 6, and 12</time_frame>
    <description>Graft survival was defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for &gt;8 weeks), re-transplant or death during the first 12 months after transplantation.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">128</enrollment>
  <condition>Kidney Transplantation</condition>
  <arm_group>
    <arm_group_label>Renal Transplant Participants</arm_group_label>
    <description>Renal transplant participants who will be subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, will be followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurs first. The choice of treatment will be made prior to enrolment by the treating physician. The treatment will be administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mycophenolate Mofetil</intervention_name>
    <description>Protocol does not specify any regimen for treatment. The choice of treatment will be made prior to enrollment by the treating physician.</description>
    <arm_group_label>Renal Transplant Participants</arm_group_label>
    <other_name>CellCept</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Immunosuppressive Therapy</intervention_name>
    <description>Protocol does not specify any particular immunosuppressive drug and regimen for treatment. The choice of immunosuppressive therapy will be made prior to enrollment by the treating physician.</description>
    <arm_group_label>Renal Transplant Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Renal allograft transplant participants initiated on combined immunosuppressive treatment&#xD;
        containing mycophenolate mofetil&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who underwent renal allograft transplantation and are started on combined&#xD;
             immunosuppressive treatment containing mycophenolate mofetil in accordance with the&#xD;
             indication provided by the SmPC of mycophenolate mofetil&#xD;
&#xD;
          -  Date of study enrollment is the date of kidney transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication included in the SmPC for capecitabine (Xeloda) prevailed, like:&#xD;
             Hypersensitivity to active ingredient or any of the excipients of the product;&#xD;
             Pregnancy and lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Budapest</city>
        <zip>1082</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pecs</city>
        <zip>7624</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>August 16, 2016</results_first_submitted>
  <results_first_submitted_qc>August 16, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 11, 2016</results_first_posted>
  <last_update_submitted>August 16, 2016</last_update_submitted>
  <last_update_submitted_qc>August 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycophenolic Acid</mesh_term>
    <mesh_term>Immunosuppressive Agents</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>If Informed Consent Form (ICF) was signed after the transplantation, it was considered as a major protocol violation and reported separately from protocol violation in Participant Flow.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Renal Transplant Participants</title>
          <description>Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil (CellCept), were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC). The study protocol did not specify any treatment regimen.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="128"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Intent-to-treat (ITT) Population</title>
              <participants_list>
                <participants group_id="P1" count="123">All enrolled participants who had no major protocol violation.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>ICF Signed After Transplantation</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>ITT population included all enrolled renal transplant participants who received mycophenolate mofetil containing immunosuppressive combination therapy and had no major protocol violation.</population>
      <group_list>
        <group group_id="B1">
          <title>Renal Transplant Participants</title>
          <description>Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="123"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.60" spread="13.24"/>
                  </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="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Creatinine Clearance at 1 Month After Transplantation</title>
        <description>Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.</description>
        <time_frame>Month 1</time_frame>
        <population>ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Renal Transplant Participants</title>
            <description>Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Creatinine Clearance at 1 Month After Transplantation</title>
          <description>Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.</description>
          <population>ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.82" spread="18.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Creatinine Clearance at Month 6 After Transplantation</title>
        <description>Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.</description>
        <time_frame>Month 6</time_frame>
        <population>ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Renal Transplant Participants</title>
            <description>Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Creatinine Clearance at Month 6 After Transplantation</title>
          <description>Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.</description>
          <population>ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.38" spread="19.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Creatinine Clearance at Month 12 After Transplantation</title>
        <description>Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.</description>
        <time_frame>Month 12</time_frame>
        <population>ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Renal Transplant Participants</title>
            <description>Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Creatinine Clearance at Month 12 After Transplantation</title>
          <description>Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.</description>
          <population>ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.69" spread="21.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Glomerular Filtration Rate (GFR) at Month 1 After Transplantation</title>
        <description>GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (&gt;) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (&lt;) 15 mL/min indicates kidney failure.</description>
        <time_frame>Month 1</time_frame>
        <population>ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Renal Transplant Participants</title>
            <description>Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Glomerular Filtration Rate (GFR) at Month 1 After Transplantation</title>
          <description>GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (&gt;) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (&lt;) 15 mL/min indicates kidney failure.</description>
          <population>ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.54" spread="33.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>GFR at Month 6 After Transplantation</title>
        <description>GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is &gt; 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR &lt; 15 mL/min indicates kidney failure.</description>
        <time_frame>Month 6</time_frame>
        <population>ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Renal Transplant Participants</title>
            <description>Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>GFR at Month 6 After Transplantation</title>
          <description>GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is &gt; 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR &lt; 15 mL/min indicates kidney failure.</description>
          <population>ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.78" spread="15.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>GFR at Month 12 After Transplantation</title>
        <description>GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is &gt; 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR &lt; 15 mL/min indicates kidney failure.</description>
        <time_frame>Month 12</time_frame>
        <population>ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Renal Transplant Participants</title>
            <description>Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>GFR at Month 12 After Transplantation</title>
          <description>GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is &gt; 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR &lt; 15 mL/min indicates kidney failure.</description>
          <population>ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.</population>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.03" spread="16.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Dose of Mycophenolate Mofetil</title>
        <time_frame>Baseline, Months 1, 6, and 12</time_frame>
        <population>ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.</population>
        <group_list>
          <group group_id="O1">
            <title>Renal Transplant Participants</title>
            <description>Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Dose of Mycophenolate Mofetil</title>
          <population>ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.</population>
          <units>milligrams (mg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=121)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2033.06" spread="357.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (n=119)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1718.49" spread="543.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=88)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1457.39" spread="754.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (n=69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1539.86" spread="669.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil</title>
        <description>Participants could have received more than one other immunosuppressive agents, at the discretion of treating physician. Percentage of participants who received 1 other immunosuppressive agent, 2 other immunosuppressive agents, and 3 other immunosuppressive agents are reported.</description>
        <time_frame>Baseline, Months 1, 6, and 12</time_frame>
        <population>ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.</population>
        <group_list>
          <group group_id="O1">
            <title>Renal Transplant Participants</title>
            <description>Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil</title>
          <description>Participants could have received more than one other immunosuppressive agents, at the discretion of treating physician. Percentage of participants who received 1 other immunosuppressive agent, 2 other immunosuppressive agents, and 3 other immunosuppressive agents are reported.</description>
          <population>ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 Other agent: at baseline (n=121)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Other agent: at Month 1 (n=119)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Other agent: at Month 6 (n=86)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Other agent: at Month 12 (n=69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Other agents: at baseline (n=121)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Other agents: at Month 1 (n=119)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Other agents: at Month 6 (n=86)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Other agents: at Month 12 (n=69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Other agents: at baseline (n=121)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Other agents: at Month 1 (n=119)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Other agents: at Month 6 (n=86)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Other agents: at Month 12 (n=69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Acute Rejection</title>
        <description>Percentage of participants who experienced acute rejection within 1 month of transplantation, Month 2 to Month 6 after transplantation, Month 7 to Month 12 after transplantation are reported.</description>
        <time_frame>Baseline to Month 1, Months 2 to 6, Months 7 to 12</time_frame>
        <population>Safety population included all enrolled renal transplant participants who received mycophenolate mofetil containing immunosuppressive combination therapy (safety population=128). Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.</population>
        <group_list>
          <group group_id="O1">
            <title>Renal Transplant Participants</title>
            <description>Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Acute Rejection</title>
          <description>Percentage of participants who experienced acute rejection within 1 month of transplantation, Month 2 to Month 6 after transplantation, Month 7 to Month 12 after transplantation are reported.</description>
          <population>Safety population included all enrolled renal transplant participants who received mycophenolate mofetil containing immunosuppressive combination therapy (safety population=128). Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Month 1 (n=127)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Months 2 to 6 (n=124)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Months 7 to 12 (n=111)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Graft Survival</title>
        <description>Graft survival was defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for &gt;8 weeks), re-transplant or death during the first 12 months after transplantation.</description>
        <time_frame>Months 1, 6, and 12</time_frame>
        <population>Safety population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.</population>
        <group_list>
          <group group_id="O1">
            <title>Renal Transplant Participants</title>
            <description>Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Graft Survival</title>
          <description>Graft survival was defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for &gt;8 weeks), re-transplant or death during the first 12 months after transplantation.</description>
          <population>Safety population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (n=127)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 (n=123)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (n=111)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Baseline up to Month 12</time_frame>
      <desc>Safety population.</desc>
      <group_list>
        <group group_id="E1">
          <title>Renal Transplant Participants</title>
          <description>Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Kidney transplant rejection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Transplant rejection</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Postoperative abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Complications of transplanted kidney</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Perirenal haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Ureteric anastomosis complication</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Pyelocaliectasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Ureteral disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Varicocele</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiration abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="128"/>
              </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>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800-821-8590</phone>
      <email>genentech@druginfo.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01672957
org study id: ML27844
nct id: NCT01672957
lead sponsor: 
This observational study will evaluate renal function in participants who underwent renal
      allograft transplantation and are started on combined immunosuppressive treatment containing
      mycophenolate mofetil (CellCept). Eligible participants will be followed for 12 months
      following transplantation.
The participant sampling method used in the Orange study was consecutive sampling, a
      non-probability sampling method where each participant meeting the study's inclusion and
      exclusion criteria is selected and enrolled in the study until the pre-set sample size is
      achieved.

      Thus, in the Orange study de novo kidney transplanted participants, who were on mycophenolate
      mofetil immunosuppressive combination therapy in routine clinical practice, were selected in
      a consecutive manner (a non-probability sampling method) if they met the inclusion/exclusion
      criteria until 128 participants were recruited to the study.
observational model: Cohort
time perspective: Prospective
measure: Creatinine Clearance at 1 Month After Transplantation
time frame: Month 1
description: Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
measure: Creatinine Clearance at Month 6 After Transplantation
time frame: Month 6
description: Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
measure: Creatinine Clearance at Month 12 After Transplantation
time frame: Month 12
description: Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
measure: Glomerular Filtration Rate (GFR) at Month 1 After Transplantation
time frame: Month 1
description: GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (<) 15 mL/min indicates kidney failure.
measure: GFR at Month 6 After Transplantation
time frame: Month 6
description: GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure.
measure: GFR at Month 12 After Transplantation
time frame: Month 12
description: GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure.
measure: Mean Dose of Mycophenolate Mofetil
time frame: Baseline, Months 1, 6, and 12
measure: Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil
time frame: Baseline, Months 1, 6, and 12
description: Participants could have received more than one other immunosuppressive agents, at the discretion of treating physician. Percentage of participants who received 1 other immunosuppressive agent, 2 other immunosuppressive agents, and 3 other immunosuppressive agents are reported.
measure: Percentage of Participants With Acute Rejection
time frame: Baseline to Month 1, Months 2 to 6, Months 7 to 12
description: Percentage of participants who experienced acute rejection within 1 month of transplantation, Month 2 to Month 6 after transplantation, Month 7 to Month 12 after transplantation are reported.
measure: Percentage of Participants With Graft Survival
time frame: Months 1, 6, and 12
description: Graft survival was defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), re-transplant or death during the first 12 months after transplantation.
arm group label: Renal Transplant Participants
description: Renal transplant participants who will be subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, will be followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurs first. The choice of treatment will be made prior to enrolment by the treating physician. The treatment will be administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC).
intervention type: Drug
intervention name: Mycophenolate Mofetil
description: Protocol does not specify any regimen for treatment. The choice of treatment will be made prior to enrollment by the treating physician.
arm group label: Renal Transplant Participants
other name: CellCept
intervention type: Drug
intervention name: Immunosuppressive Therapy
description: Protocol does not specify any particular immunosuppressive drug and regimen for treatment. The choice of immunosuppressive therapy will be made prior to enrollment by the treating physician.
arm group label: Renal Transplant Participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
country: Hungary
responsible party type: Sponsor
mesh term: Mycophenolic Acid
mesh term: Immunosuppressive Agents
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 