<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/NCT04473924</url>
  </required_header>
  <id_info>
    <org_study_id>20-31500</org_study_id>
    <nct_id>NCT04473924</nct_id>
  </id_info>
  <brief_title>Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk</brief_title>
  <acronym>STIFLE-RISK</acronym>
  <official_title>Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</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>
      Infections are common and associated with poor outcomes as well as high financial costs after&#xD;
      kidney transplantation. Identifying and implementing strategies to reduce infections after&#xD;
      kidney transplantation is important for improving patient outcomes. This study seeks to&#xD;
      determine the feasibility of body surface area-based dosing of mycophenolate compared to&#xD;
      standard dosing of mycophenolate in a pilot randomized controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study has never started as sponsor did not approve for funding.&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2022</start_date>
  <completion_date type="Anticipated">May 2023</completion_date>
  <primary_completion_date type="Anticipated">January 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Enrollment rate in a trial of BSA-based vs. fixed dosing of mycophenolate</measure>
    <time_frame>6 months</time_frame>
    <description>Assess the ratio of participants screened to enrolled into the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of a trial of BSA-based vs. fixed dosing of mycophenolate</measure>
    <time_frame>6 months</time_frame>
    <description>Assess the rate of dropout from the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate</measure>
    <time_frame>6 months</time_frame>
    <description>Collect pilot data on number of overall hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate</measure>
    <time_frame>6 months</time_frame>
    <description>Collect pilot data on infectious-related hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate</measure>
    <time_frame>6 months</time_frame>
    <description>Collect pilot data on incidence of leukopenia</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Infection</condition>
  <condition>Transplant;Failure,Kidney</condition>
  <arm_group>
    <arm_group_label>Body surface area-based mycophenolate dosing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention group will receive mycophenolate mofetil 750 mg/m^2/day divided into twice daily dosing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard (fixed) dosing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active comparator group will receive standard fixed dosing of mycophenolate mofetil 1000 mg twice daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mycophenolate Mofetil</intervention_name>
    <description>Body surface area-based dosing of mycophenolate</description>
    <arm_group_label>Body surface area-based mycophenolate dosing</arm_group_label>
    <other_name>Cellcept</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mycophenolate Mofetil</intervention_name>
    <description>Standard (fixed) dosing of mycophenolate</description>
    <arm_group_label>Standard (fixed) dosing</arm_group_label>
    <other_name>Cellcept</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult transplant recipients ≥18 years of age who have a functional allograft and have&#xD;
             undergone kidney transplantation between six months and two years prior to study&#xD;
             enrollment&#xD;
&#xD;
          -  Receiving mycophenolate mofetil for maintenance transplant immunosuppression at the&#xD;
             time of the screening visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of rejection on routine six month post-transplant biopsy&#xD;
&#xD;
          -  Prior intolerance to mycophenolate mofetil necessitating drug discontinuation&#xD;
&#xD;
          -  Are or are planning to become pregnant, due to inability to take mycophenolate&#xD;
&#xD;
          -  Are marginally housed, due to concerns regarding routine follow-up&#xD;
&#xD;
          -  Are actively participating in a different interventional trial that may affect&#xD;
             immunosuppression dosing&#xD;
&#xD;
          -  Are unwilling to consent to participate&#xD;
&#xD;
          -  Institutionalized individuals or prisoners&#xD;
&#xD;
          -  Are actively abusing illicit drugs or alcohol&#xD;
&#xD;
          -  Have a history of poor or doubtful compliance (e.g., frequently missed appointments)&#xD;
&#xD;
          -  Have cognitive impairment prohibiting participation in the study&#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>Elaine Ku, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>May 2, 2022</last_update_submitted>
  <last_update_submitted_qc>May 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycophenolic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04473924
org study id: 20-31500
nct id: NCT04473924
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Infections are common and associated with poor outcomes as well as high financial costs after
      kidney transplantation. Identifying and implementing strategies to reduce infections after
      kidney transplantation is important for improving patient outcomes. This study seeks to
      determine the feasibility of body surface area-based dosing of mycophenolate compared to
      standard dosing of mycophenolate in a pilot randomized controlled trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Enrollment rate in a trial of BSA-based vs. fixed dosing of mycophenolate
time frame: 6 months
description: Assess the ratio of participants screened to enrolled into the study
measure: Feasibility of a trial of BSA-based vs. fixed dosing of mycophenolate
time frame: 6 months
description: Assess the rate of dropout from the study
measure: Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate
time frame: 6 months
description: Collect pilot data on number of overall hospitalizations
measure: Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate
time frame: 6 months
description: Collect pilot data on infectious-related hospitalizations
measure: Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate
time frame: 6 months
description: Collect pilot data on incidence of leukopenia
arm group label: Body surface area-based mycophenolate dosing
arm group type: Experimental
description: Intervention group will receive mycophenolate mofetil 750 mg/m^2/day divided into twice daily dosing.
arm group label: Standard (fixed) dosing
arm group type: Active Comparator
description: Active comparator group will receive standard fixed dosing of mycophenolate mofetil 1000 mg twice daily.
intervention type: Drug
intervention name: Mycophenolate Mofetil
description: Body surface area-based dosing of mycophenolate
arm group label: Body surface area-based mycophenolate dosing
other name: Cellcept
intervention type: Drug
intervention name: Mycophenolate Mofetil
description: Standard (fixed) dosing of mycophenolate
arm group label: Standard (fixed) dosing
other name: Cellcept
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elaine Ku, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Mycophenolic Acid
sharing ipd: No