<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/NCT02991768</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00140436</org_study_id>
    <nct_id>NCT02991768</nct_id>
  </id_info>
  <brief_title>Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients</brief_title>
  <official_title>Budesonide for Mycophenolic Acid (MPA)-Induced Diarrhea in Renal Transplant Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pooja Budhiraja, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</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 learn if using a Entocort (budesonide) to treat diarrhea will&#xD;
      be effective and safe for kidney transplant patients, allowing them to continue with MPA&#xD;
      medication.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Enrollment not continued&#xD;
  </why_stopped>
  <start_date type="Actual">January 27, 2017</start_date>
  <completion_date type="Actual">April 26, 2019</completion_date>
  <primary_completion_date type="Actual">April 26, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete remission of diarrhea</measure>
    <time_frame>Week 8</time_frame>
    <description>Measured using symptom diary. Complete remission (CR) is defined as a mean of &lt;3 stools/day and a mean of &lt;1 watery stool per day without use of anti-diarrheal drugs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Gastrointestinal Symptom Rating Scale (GSRS)</measure>
    <time_frame>Change from Baseline to Week 8</time_frame>
    <description>GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. The GSRS consists of 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gastrointestinal Symptom Rating Scale (GSRS)</measure>
    <time_frame>Change from Baseline to Week 16</time_frame>
    <description>GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. The GSRS consists of 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gastrointestinal Quality of Life Index (GIQLI)</measure>
    <time_frame>Change from Baseline to Week 8</time_frame>
    <description>The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 subscales (GI symptoms, emotional status, physical functions, social functions, and stress of medical treatment), producing a total score of the 36 items. Lower scores represent more dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gastrointestinal Quality of Life Index (GIQLI)</measure>
    <time_frame>Change from Baseline to Week 16</time_frame>
    <description>The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 subscales (GI symptoms, emotional status, physical functions, social functions, and stress of medical treatment), producing a total score of the 36 items. Lower scores represent more dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MPA Dose</measure>
    <time_frame>Change from Baseline to Week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MPA Dose</measure>
    <time_frame>Change from Baseline to Week 16</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Diarrhea</condition>
  <arm_group>
    <arm_group_label>Entocort EC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will take 6mg matching placebo pill daily for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Entocort</intervention_name>
    <description>A corticosteroid that decreases levels of inflammatory cytokines.</description>
    <arm_group_label>Entocort EC</arm_group_label>
    <other_name>budesonide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Placebo is matched to the study drug.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Kidney transplant recipients &gt; 1 months post-transplant,&#xD;
&#xD;
          -  No history of chronic diarrhea pre-transplant,&#xD;
&#xD;
          -  &gt;3 watery/soft stools after transplant on at least 4 days in the week without&#xD;
             anti-diarrheal for at least 2 weeks or using anti-diarrheals for at least 4 days in&#xD;
             the week &gt; 2 weeks&#xD;
&#xD;
          -  Subjects on at least 180mg twice a day of mycophenolate-sodium or 250 mg twice a day&#xD;
             of cellcept&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of any known colonic diseases (i.e. Crohn's disease, ulcerative colitis,&#xD;
             ischemic colitis, Celiac disease), partial colonic resection, small bowel resection,&#xD;
             history of cholecystectomy, Irritable Bowel Syndrome, fecal Incontinence, Bacterial&#xD;
             overgrowth, infectious diarrhea (c difficle, cryptospora, giardia, isospora, Human&#xD;
             Immunodeficiency Virus), Cytomegalovirus colitis&#xD;
&#xD;
          -  Subjects with recent acute rejection treated with high dose steroids&#xD;
&#xD;
          -  Subjects taking Boswellia serrata extract, over-the-counter herbs, cholestyramine,&#xD;
             nonsteroidal salicylates (other than daily ASA)&#xD;
&#xD;
          -  Subjects with active malignancy, liver cirrhosis, active peptic ulcer disease, known&#xD;
             intolerance or resistance to budesonide, pregnancy, breast-feeding, mental retardation&#xD;
&#xD;
          -  Unable to provide informed consent&#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>Pooja Budhiraja, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>May 16, 2019</last_update_submitted>
  <last_update_submitted_qc>May 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
    <investigator_full_name>Pooja Budhiraja, MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Budesonide</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02991768
org study id: STUDY00140436
nct id: NCT02991768
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to learn if using a Entocort (budesonide) to treat diarrhea will
      be effective and safe for kidney transplant patients, allowing them to continue with MPA
      medication.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Complete remission of diarrhea
time frame: Week 8
description: Measured using symptom diary. Complete remission (CR) is defined as a mean of <3 stools/day and a mean of <1 watery stool per day without use of anti-diarrheal drugs.
measure: Change in Gastrointestinal Symptom Rating Scale (GSRS)
time frame: Change from Baseline to Week 8
description: GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. The GSRS consists of 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).
measure: Change in Gastrointestinal Symptom Rating Scale (GSRS)
time frame: Change from Baseline to Week 16
description: GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. The GSRS consists of 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).
measure: Change in Gastrointestinal Quality of Life Index (GIQLI)
time frame: Change from Baseline to Week 8
description: The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 subscales (GI symptoms, emotional status, physical functions, social functions, and stress of medical treatment), producing a total score of the 36 items. Lower scores represent more dysfunction.
measure: Change in Gastrointestinal Quality of Life Index (GIQLI)
time frame: Change from Baseline to Week 16
description: The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 subscales (GI symptoms, emotional status, physical functions, social functions, and stress of medical treatment), producing a total score of the 36 items. Lower scores represent more dysfunction.
measure: MPA Dose
time frame: Change from Baseline to Week 8
measure: MPA Dose
time frame: Change from Baseline to Week 16
arm group label: Entocort EC
arm group type: Experimental
description: Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will take 6mg matching placebo pill daily for 8 weeks.
intervention type: Drug
intervention name: Entocort
description: A corticosteroid that decreases levels of inflammatory cytokines.
arm group label: Entocort EC
other name: budesonide
intervention type: Drug
intervention name: Placebos
description: Placebo is matched to the study drug.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pooja Budhiraja, MD
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kansas Medical Center
investigator full name: Pooja Budhiraja, MD
investigator title: Assistant Professor
mesh term: Diarrhea
mesh term: Budesonide