xml: <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/NCT06034925</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00125967</org_study_id>
      <nct_id>NCT06034925</nct_id>
    </id_info>
    <brief_title>Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients</brief_title>
    <official_title>Randomized Controlled Trial Comparing the Tolerability and Efficacy of Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Takeda</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Medical University of South Carolina</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 find out if there is a difference in how well the standard&#xD;
        MUSC cytomegalovirus (CMV) prevention medicine works, compared to a different medicine, in&#xD;
        preventing CMV infections in kidney transplant recipients who are at risk for this type of&#xD;
        infection, while also assessing the tolerability of these two regimens. The two medication&#xD;
        regimens being compared are Valganciclovir (FDA approved to prevent and treat CMV infection)&#xD;
        vs Maribavir (FDA approved to treat CMV infection) plus Acyclovir (FDA approved to prevent&#xD;
        HSV infection).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Maribavir has been evaluated for the prevention of CMV infection in Phase II and Phase III&#xD;
        trials within allogeneic stem cell transplant recipients. At 6-months post-transplant, the&#xD;
        rates of CMV infection using PCR were not different between treatment and placebo arms,&#xD;
        although the rates of pp65 antigenemia were lower in the Maribavir group. However, these&#xD;
        studies used a low dose of 100mg PO BID. In subsequent studies within solid organ&#xD;
        transplantation, Maribavir dosed at 400 to 1200mg PO BID was equally efficacious to&#xD;
        valganciclovir for the treatment of CMV infection. Of note and importance to this proposal,&#xD;
        the rates of neutropenia were 4-5% in the Maribavir treated patients vs. 15-18% in&#xD;
        Valganciclovir patients. Thus, at an appropriate dose, Maribavir appears to have similar&#xD;
        efficacy to Valganciclovir in treating CMV infection with a significantly reduced incidence&#xD;
        of neutropenia. Currently, there is a lack of randomized controlled trials assessing the&#xD;
        safety and efficacy of adequately dosed (=400mg PO BID) Maribavir for the prevention of CMV&#xD;
        infection in solid organ transplant recipients.&#xD;
  &#xD;
        Aim 1. Assess the incidence of leukopenia in those randomized to Maribavir vs. Valganciclovir&#xD;
        prophylaxis in adult kidney transplant recipients at high-risk of CMV infection.&#xD;
  &#xD;
        Hypothesis 1. The incidence of clinically meaningful leukopenia, defined as a WBC count of &lt;&#xD;
        3,000 cells/mm3 and a reduction in total mycophenolate dose below 1,500 mg/day or&#xD;
        valganciclovir dose below 900mg per day (adjusted for renal function), will be significantly&#xD;
        lower in the Maribavir arm, as compared to the Valganciclovir arm.&#xD;
  &#xD;
        Aim 2. Assess the efficacy of Maribavir vs. Valganciclovir prophylaxis in adult kidney&#xD;
        transplant recipients at high-risk of CMV infection.&#xD;
  &#xD;
        Hypothesis 2. The incidence of CMV infection and disease will be similar between the&#xD;
        Maribavir arm, as compared to the Valganciclovir arm, at 3-, 6-, and 12-months&#xD;
        post-transplant.&#xD;
  &#xD;
        Aim 3. Assess the impact of Maribavir vs. Valganciclovir prophylaxis on healthcare&#xD;
        utilization and costs in adult kidney transplant recipients at high-risk of CMV infection.&#xD;
  &#xD;
        Hypothesis 3. Healthcare utilization will be lower in the Maribavir arm, as compared to the&#xD;
        Valganciclovir arm, at 6- and 12-months post-transplant, driven predominantly by reduced&#xD;
        number of telephone calls, televisits, and laboratory monitoring encounters.&#xD;
  &#xD;
        Exploratory Aim 4. Assess the impact of Maribavir vs. Valganciclovir prophylaxis in adult&#xD;
        kidney transplant recipients at high-risk of CMV infection on patient-reported outcomes for&#xD;
        quality of life and satisfaction.&#xD;
  &#xD;
        Exploratory Aim 5. Assess any differences in leukopenia, efficacy, healthcare utilization and&#xD;
        patient reported outcomes by race and sex in patients randomized to Maribavir vs.&#xD;
        Valganciclovir prophylaxis in adult kidney transplant recipients at high-risk of CMV&#xD;
        infection.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2025</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Compare the proportion of patients that develop leukopenia in those randomized to maribavir versus those randomized to valganciclovir prophylaxis in adult kidney transplant recipients at high-risk of CMV infection.</measure>
      <time_frame>One year following transplant</time_frame>
      <description>Leukopenia is defined as a white blood cell count &lt;3000 cells/mm3</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Compare the proportion of patients that develop cytomegalovirus (CMV) infection in those randomized to maribavir versus those randomized to valganciclovir prophylaxis in adult kidney transplant recipients at high-risk of CMV infection.</measure>
      <time_frame>One year following transplant</time_frame>
      <description>CMV infection is defined as having at least one CMV DNA PCR test of &gt;1000 copies/mL</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Transplant Complication</condition>
    <condition>CMV</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>valganciclovir 900mg once daily</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>maribavir 400mg twice daily</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Maribavir</intervention_name>
      <description>maribavir 400mg twice daily</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Valganciclovir</intervention_name>
      <description>valganciclovir 900mg once daily</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Kidney transplant recipient at study institution&#xD;
  &#xD;
            -  =7 days of transplant&#xD;
  &#xD;
            -  Received at least one dose of rATG induction or patient is D+/R- CMV serostatus&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;18 years at time of transplant&#xD;
  &#xD;
            -  Recipient of pancreas, liver, heart, lung transplant&#xD;
  &#xD;
            -  Recipient of investigational, non-FDA approved medication&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Medical University of South Carolina</name>
        <address>
          <city>Charleston</city>
          <state>South Carolina</state>
          <zip>29425</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
      <investigator_full_name>David J. Taber</investigator_full_name>
      <investigator_title>Professor-Faculty</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Valganciclovir</mesh_term>
      <mesh_term>Maribavir</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06034925
  org study id: Pro00125967
  nct id: NCT06034925
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The purpose of this study is to find out if there is a difference in how well the standard
        MUSC cytomegalovirus (CMV) prevention medicine works, compared to a different medicine, in
        preventing CMV infections in kidney transplant recipients who are at risk for this type of
        infection, while also assessing the tolerability of these two regimens. The two medication
        regimens being compared are Valganciclovir (FDA approved to prevent and treat CMV infection)
        vs Maribavir (FDA approved to treat CMV infection) plus Acyclovir (FDA approved to prevent
        HSV infection).
  Maribavir has been evaluated for the prevention of CMV infection in Phase II and Phase III
        trials within allogeneic stem cell transplant recipients. At 6-months post-transplant, the
        rates of CMV infection using PCR were not different between treatment and placebo arms,
        although the rates of pp65 antigenemia were lower in the Maribavir group. However, these
        studies used a low dose of 100mg PO BID. In subsequent studies within solid organ
        transplantation, Maribavir dosed at 400 to 1200mg PO BID was equally efficacious to
        valganciclovir for the treatment of CMV infection. Of note and importance to this proposal,
        the rates of neutropenia were 4-5% in the Maribavir treated patients vs. 15-18% in
        Valganciclovir patients. Thus, at an appropriate dose, Maribavir appears to have similar
        efficacy to Valganciclovir in treating CMV infection with a significantly reduced incidence
        of neutropenia. Currently, there is a lack of randomized controlled trials assessing the
        safety and efficacy of adequately dosed (=400mg PO BID) Maribavir for the prevention of CMV
        infection in solid organ transplant recipients.
  
        Aim 1. Assess the incidence of leukopenia in those randomized to Maribavir vs. Valganciclovir
        prophylaxis in adult kidney transplant recipients at high-risk of CMV infection.
  
        Hypothesis 1. The incidence of clinically meaningful leukopenia, defined as a WBC count of <
        3,000 cells/mm3 and a reduction in total mycophenolate dose below 1,500 mg/day or
        valganciclovir dose below 900mg per day (adjusted for renal function), will be significantly
        lower in the Maribavir arm, as compared to the Valganciclovir arm.
  
        Aim 2. Assess the efficacy of Maribavir vs. Valganciclovir prophylaxis in adult kidney
        transplant recipients at high-risk of CMV infection.
  
        Hypothesis 2. The incidence of CMV infection and disease will be similar between the
        Maribavir arm, as compared to the Valganciclovir arm, at 3-, 6-, and 12-months
        post-transplant.
  
        Aim 3. Assess the impact of Maribavir vs. Valganciclovir prophylaxis on healthcare
        utilization and costs in adult kidney transplant recipients at high-risk of CMV infection.
  
        Hypothesis 3. Healthcare utilization will be lower in the Maribavir arm, as compared to the
        Valganciclovir arm, at 6- and 12-months post-transplant, driven predominantly by reduced
        number of telephone calls, televisits, and laboratory monitoring encounters.
  
        Exploratory Aim 4. Assess the impact of Maribavir vs. Valganciclovir prophylaxis in adult
        kidney transplant recipients at high-risk of CMV infection on patient-reported outcomes for
        quality of life and satisfaction.
  
        Exploratory Aim 5. Assess any differences in leukopenia, efficacy, healthcare utilization and
        patient reported outcomes by race and sex in patients randomized to Maribavir vs.
        Valganciclovir prophylaxis in adult kidney transplant recipients at high-risk of CMV
        infection.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Compare the proportion of patients that develop leukopenia in those randomized to maribavir versus those randomized to valganciclovir prophylaxis in adult kidney transplant recipients at high-risk of CMV infection.
  time frame: One year following transplant
  description: Leukopenia is defined as a white blood cell count <3000 cells/mm3
  measure: Compare the proportion of patients that develop cytomegalovirus (CMV) infection in those randomized to maribavir versus those randomized to valganciclovir prophylaxis in adult kidney transplant recipients at high-risk of CMV infection.
  time frame: One year following transplant
  description: CMV infection is defined as having at least one CMV DNA PCR test of >1000 copies/mL
  arm group label: Control
  arm group type: Active Comparator
  description: valganciclovir 900mg once daily
  arm group label: Intervention
  arm group type: Experimental
  description: maribavir 400mg twice daily
  intervention type: Drug
  intervention name: Maribavir
  description: maribavir 400mg twice daily
  arm group label: Intervention
  intervention type: Drug
  intervention name: Valganciclovir
  description: valganciclovir 900mg once daily
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Medical University of South Carolina
  investigator full name: David J. Taber
  investigator title: Professor-Faculty
  mesh term: Valganciclovir
  mesh term: Maribavir