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/NCT06042153</url>
    </required_header>
    <id_info>
      <org_study_id>STU-2022-0786</org_study_id>
      <nct_id>NCT06042153</nct_id>
    </id_info>
    <brief_title>DIALYSIS-TIR Study</brief_title>
    <official_title>Semaglutide for Dialysis-Treated Patients - a Glucose Time in Range Study- DIALYSIS-TIR Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Texas Southwestern Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of North Carolina, Chapel Hill</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Texas Southwestern 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>
        This study will look at control of blood sugar levels in persons with type 2 diabetes&#xD;
        mellitus currently on chronic dialysis. Researchers will compare blood sugar levels in people&#xD;
        taking semaglutide to people taking &quot;dummy&quot; medicine. The treatment participants get will be&#xD;
        decided randomly.&#xD;
  &#xD;
        Participants will need to inject the study medication once a week. The study will last for 1&#xD;
        year and a month. Participants will be asked to wear a sensor that measures blood sugar&#xD;
        levels for a period of 10 days at five different time points during the study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The researchers also have a Data Safety Monitoring Plan in place.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 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>
      <intervention_model_description>This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled, trial comparing semaglutide subcutaneously weekly versus matched placebo</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>The randomization and each dispensation will be performed by blinded study staff using an electronic system coded with the randomization code, to ensure all study personnel remains blinded.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in TIR (70-180 mg/dl)</measure>
      <time_frame>Baseline, 52 weeks</time_frame>
      <description>Measured in percentage by Continuous glucose monitor (CGM)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Time in high range (180-250 mg/dl)</measure>
      <time_frame>Baseline, 52 weeks</time_frame>
      <description>Measured in percentage by Continuous glucose monitor (CGM)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Time in very high range (&gt;250 mg/dl)</measure>
      <time_frame>Baseline, 52 weeks</time_frame>
      <description>Measured in percentage by Continuous glucose monitor (CGM)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Time in low range (54-69 mg/dl)</measure>
      <time_frame>Baseline, 52 weeks</time_frame>
      <description>Measured in percentage by Continuous glucose monitor (CGM)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Time in very low range (&lt;54 mg/dl)</measure>
      <time_frame>Baseline, 52 weeks</time_frame>
      <description>Measured in percentage by Continuous glucose monitor (CGM)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with TIR 70-180 mg/dl for 70% of the day</measure>
      <time_frame>52 weeks</time_frame>
      <description>Measured in percentage by CGM</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with TIR 70-180 mg/dl with more than equal to 5% improvement from baseline</measure>
      <time_frame>52 weeks</time_frame>
      <description>Measured in percentage by CGM</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with Time below range &lt;70 mg/dL for &lt;4% of each day</measure>
      <time_frame>52 weeks</time_frame>
      <description>Measured in percentage by CGM</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with Time below range &lt;54 mg/dL for &lt;1% of each day</measure>
      <time_frame>52 weeks</time_frame>
      <description>Measured in percentage by CGM</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with Time above range &gt;180 mg/dL for &lt;25% of each day</measure>
      <time_frame>52 weeks</time_frame>
      <description>Measured in percentage by CGM</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in haemoglobin A1c (HbA1c)</measure>
      <time_frame>Baseline, 52 weeks</time_frame>
      <description>Measured in percentage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total daily dose of insulin</measure>
      <time_frame>52 weeks</time_frame>
      <description>Measured as units/day</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of oral glucose lowering agents</measure>
      <time_frame>52 weeks</time_frame>
      <description>Measured as count</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with &gt;10 points improvement in % TIR 70-180 mg/dL without an increase in time below range &lt;54 mg/dL of &gt;0.5%</measure>
      <time_frame>52 weeks</time_frame>
      <description>Measured in percentage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with mean glucose &lt;154 mg/dL and &lt;1% time below range &lt;54 mg/dL</measure>
      <time_frame>52 weeks</time_frame>
      <description>Measured in percentage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with Severe hypoglycemia</measure>
      <time_frame>52 weeks</time_frame>
      <description>Measured in count</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in body weight</measure>
      <time_frame>Baseline, 52 weeks</time_frame>
      <description>Measured in kilograms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in waist circumference</measure>
      <time_frame>Baseline, 52 weeks</time_frame>
      <description>Measured in centimeters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in percentage total body fat</measure>
      <time_frame>Baseline, 52 weeks</time_frame>
      <description>Measured in percentage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in percentage lean mass</measure>
      <time_frame>Baseline, 52 weeks</time_frame>
      <description>Measured in percentage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Inter-dialysis weight gain</measure>
      <time_frame>Baseline, 52 weeks</time_frame>
      <description>Measured in kilograms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants hospitalized</measure>
      <time_frame>52 weeks</time_frame>
      <description>Measured in count</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total number of days spent in hospital</measure>
      <time_frame>52 weeks</time_frame>
      <description>Measured in count</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total score of Diabetes Treatment Satisfaction questionnaire</measure>
      <time_frame>52 weeks</time_frame>
      <description>Patient reported outcomes is assessed by Diabetes Treatment Satisfaction Score questionnaire which assesses patient satisfaction with diabetes treatment. It is composed of eight questions, each of which is scored by patients on a scale ranging from zero (e.g., &quot;very dissatisfied&quot;, &quot;very inconvenient&quot;) to six (e.g., &quot;very satisfied&quot;, &quot;very convenient&quot;). Treatment satisfaction is assessed as the sum of the scores of the six questions on the first factor, with a higher score indicating higher treatment satisfaction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total score of EQ-5D-5L</measure>
      <time_frame>52 weeks</time_frame>
      <description>The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.&#xD;
  The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. Possible scores range from 0-100, where higher score indicate better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total score of Kidney disease QoL short form</measure>
      <time_frame>52 weeks</time_frame>
      <description>The KDQOL-SF is a self-report measure developed for individuals with kidney disease and those on dialysis. It is a shorter version of a measure developed by the same authors. It includes 43 kidney disease-targeted items, such as the effects of the disease of activities of daily living, work status, and social interaction, and 36 items that provide a measure of physical and mental health, and 1 overall health rating item ranging from 0 (&quot;worst possible health&quot;) to 10 (&quot;best possible health.&quot;).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">157</enrollment>
    <condition>Type 2 Diabetes</condition>
    <condition>End Stage Renal Disease on Dialysis</condition>
    <arm_group>
      <arm_group_label>Arm 1 - Semaglutide</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive semaglutide as an adjunct to standard-of-care.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 2- Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will receive placebo (semaglutide) as an adjunct to standard-of-care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Semaglutide</intervention_name>
      <description>Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Subjects will start semaglutide treatment at 0.25 mg; dose will gradually be increased every 4 weeks up to 1.0 mg.</description>
      <arm_group_label>Arm 1 - Semaglutide</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Participants will receive placebo at an equivalent dose to semaglutide.</description>
      <arm_group_label>Arm 2- Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Ability to provide informed consent before any trial-related activities. Trial-related&#xD;
               activities are any procedures that are carried out as a part of trial, including&#xD;
               activities to determine suitability for the trial.&#xD;
  &#xD;
            2. Male or female Adults (age &gt; 18 years at the time of signing the consent)&#xD;
  &#xD;
            3. Type 2 diabetes mellitus diagnosed &gt; 6 months prior to screening&#xD;
  &#xD;
            4. On current chronic treatment with Hemodialysis or Peritoneal dialysis for &gt; 6 months&#xD;
               prior to screening&#xD;
  &#xD;
            5. Current treatment with any glucose lowering pharmacotherapy, at a stable dose for at&#xD;
               least 30 days. DPP-4 Inhibitors will be allowed at study entry and will be stopped at&#xD;
               randomization.&#xD;
  &#xD;
            6. Minimum of 80% valid data on the 10-day Continuous Glucose Monitor download&#xD;
  &#xD;
            7. Time in Range 15 to 60%&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. BMI &lt; 23 kg/m2 at screening&#xD;
  &#xD;
            2. Current (within the past 90 days of screening) use of any GLP-1 RA&#xD;
  &#xD;
            3. Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia&#xD;
               type 2&#xD;
  &#xD;
            4. Known or suspected hypersensitivity to GLP-1 RA (trial medication(s), excipients, or&#xD;
               related products)&#xD;
  &#xD;
            5. Pregnant, breast-feeding or the intention of becoming pregnant, or not using effective&#xD;
               contraceptive measures&#xD;
  &#xD;
            6. Active weight loss, defined as weight loss of &gt;5% of body weight in the past 3 months&#xD;
  &#xD;
            7. Current participation in other interventional trials or last dose of any&#xD;
               investigational product within 4 half- lives at the time of randomization&#xD;
  &#xD;
            8. Any medical condition which in the judgement of the investigator precludes safe&#xD;
               participation in the trial (includes, but not limited to active neoplasm, severe heart&#xD;
               failure, recent cardiovascular event, severe frailty, planned cardiac or vascular&#xD;
               surgeries on the day of screening etc)&#xD;
  &#xD;
            9. If weight loss is not desired by the participant, or if the provider or investigator&#xD;
               considers intentional weight loss to be detrimental to the health of the participant&#xD;
  &#xD;
           10. Other or secondary forms of diabetes (like type 1 diabetes, pancreatogenic diabetes&#xD;
               mellitus, MODY, LADA, drug induced, etc.)&#xD;
  &#xD;
           11. Current diagnosis of gastroparesis or enteropathywhich in the opinion of investigator&#xD;
               precludes safe treatment with GLP-1 RA.&#xD;
  &#xD;
           12. Hypoglycaemia unawareness, or history of frequent or severe hypoglycaemia (in the&#xD;
               opinion of the investigator)&#xD;
  &#xD;
           13. Personal history of chronic pancreatitis, or acute pancreatitis within 180 days of&#xD;
               screening&#xD;
  &#xD;
           14. Known current uncontrolled or unstable retinopathy (by medical history)&#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>Ildiko Lingvay, MD, MPH, MSCS</last_name>
      <role>Principal Investigator</role>
      <affiliation>UT Southwestern Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marielle Berger-Nagele, MS</last_name>
      <phone>214-648-2363</phone>
      <email>marielle.berger-nagele@utsouthwestern.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ileana Cuevas, PhD</last_name>
      <phone>214-648-2321</phone>
      <email>ileana.cuevas@utsouthwestern.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of North Carolina</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27599</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Alex Kass, MSN, MBA, RN</last_name>
        <phone>984-974-3009</phone>
        <email>alex_kass@med.unc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Klara Klein, MD</last_name>
        <phone>9849743004</phone>
        <email>klara_klein@med.unc.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Klara Klein, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
      <investigator_full_name>Ildiko Lingvay</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Failure, Chronic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06042153
  org study id: STU-2022-0786
  nct id: NCT06042153
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This study will look at control of blood sugar levels in persons with type 2 diabetes
        mellitus currently on chronic dialysis. Researchers will compare blood sugar levels in people
        taking semaglutide to people taking "dummy" medicine. The treatment participants get will be
        decided randomly.
  
        Participants will need to inject the study medication once a week. The study will last for 1
        year and a month. Participants will be asked to wear a sensor that measures blood sugar
        levels for a period of 10 days at five different time points during the study.
  The researchers also have a Data Safety Monitoring Plan in place.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled, trial comparing semaglutide subcutaneously weekly versus matched placebo
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: The randomization and each dispensation will be performed by blinded study staff using an electronic system coded with the randomization code, to ensure all study personnel remains blinded.
  measure: Change in TIR (70-180 mg/dl)
  time frame: Baseline, 52 weeks
  description: Measured in percentage by Continuous glucose monitor (CGM)
  measure: Change in Time in high range (180-250 mg/dl)
  time frame: Baseline, 52 weeks
  description: Measured in percentage by Continuous glucose monitor (CGM)
  measure: Change in Time in very high range (>250 mg/dl)
  time frame: Baseline, 52 weeks
  description: Measured in percentage by Continuous glucose monitor (CGM)
  measure: Change in Time in low range (54-69 mg/dl)
  time frame: Baseline, 52 weeks
  description: Measured in percentage by Continuous glucose monitor (CGM)
  measure: Change in Time in very low range (<54 mg/dl)
  time frame: Baseline, 52 weeks
  description: Measured in percentage by Continuous glucose monitor (CGM)
  measure: Proportion of participants with TIR 70-180 mg/dl for 70% of the day
  time frame: 52 weeks
  description: Measured in percentage by CGM
  measure: Proportion of participants with TIR 70-180 mg/dl with more than equal to 5% improvement from baseline
  time frame: 52 weeks
  description: Measured in percentage by CGM
  measure: Proportion of participants with Time below range <70 mg/dL for <4% of each day
  time frame: 52 weeks
  description: Measured in percentage by CGM
  measure: Proportion of participants with Time below range <54 mg/dL for <1% of each day
  time frame: 52 weeks
  description: Measured in percentage by CGM
  measure: Proportion of participants with Time above range >180 mg/dL for <25% of each day
  time frame: 52 weeks
  description: Measured in percentage by CGM
  measure: Change in haemoglobin A1c (HbA1c)
  time frame: Baseline, 52 weeks
  description: Measured in percentage
  measure: Total daily dose of insulin
  time frame: 52 weeks
  description: Measured as units/day
  measure: Number of oral glucose lowering agents
  time frame: 52 weeks
  description: Measured as count
  measure: Proportion of participants with >10 points improvement in % TIR 70-180 mg/dL without an increase in time below range <54 mg/dL of >0.5%
  time frame: 52 weeks
  description: Measured in percentage
  measure: Proportion of participants with mean glucose <154 mg/dL and <1% time below range <54 mg/dL
  time frame: 52 weeks
  description: Measured in percentage
  measure: Number of participants with Severe hypoglycemia
  time frame: 52 weeks
  description: Measured in count
  measure: Change in body weight
  time frame: Baseline, 52 weeks
  description: Measured in kilograms
  measure: Change in waist circumference
  time frame: Baseline, 52 weeks
  description: Measured in centimeters
  measure: Change in percentage total body fat
  time frame: Baseline, 52 weeks
  description: Measured in percentage
  measure: Change in percentage lean mass
  time frame: Baseline, 52 weeks
  description: Measured in percentage
  measure: Change in Inter-dialysis weight gain
  time frame: Baseline, 52 weeks
  description: Measured in kilograms
  measure: Number of participants hospitalized
  time frame: 52 weeks
  description: Measured in count
  measure: Total number of days spent in hospital
  time frame: 52 weeks
  description: Measured in count
  measure: Total score of Diabetes Treatment Satisfaction questionnaire
  time frame: 52 weeks
  description: Patient reported outcomes is assessed by Diabetes Treatment Satisfaction Score questionnaire which assesses patient satisfaction with diabetes treatment. It is composed of eight questions, each of which is scored by patients on a scale ranging from zero (e.g., "very dissatisfied", "very inconvenient") to six (e.g., "very satisfied", "very convenient"). Treatment satisfaction is assessed as the sum of the scores of the six questions on the first factor, with a higher score indicating higher treatment satisfaction.
  measure: Total score of EQ-5D-5L
  time frame: 52 weeks
  description: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
  The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. Possible scores range from 0-100, where higher score indicate better outcome
  measure: Total score of Kidney disease QoL short form
  time frame: 52 weeks
  description: The KDQOL-SF is a self-report measure developed for individuals with kidney disease and those on dialysis. It is a shorter version of a measure developed by the same authors. It includes 43 kidney disease-targeted items, such as the effects of the disease of activities of daily living, work status, and social interaction, and 36 items that provide a measure of physical and mental health, and 1 overall health rating item ranging from 0 ("worst possible health") to 10 ("best possible health.").
  arm group label: Arm 1 - Semaglutide
  arm group type: Experimental
  description: Participants will receive semaglutide as an adjunct to standard-of-care.
  arm group label: Arm 2- Placebo
  arm group type: Placebo Comparator
  description: Participants will receive placebo (semaglutide) as an adjunct to standard-of-care.
  intervention type: Drug
  intervention name: Semaglutide
  description: Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Subjects will start semaglutide treatment at 0.25 mg; dose will gradually be increased every 4 weeks up to 1.0 mg.
  arm group label: Arm 1 - Semaglutide
  intervention type: Drug
  intervention name: Placebo
  description: Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Participants will receive placebo at an equivalent dose to semaglutide.
  arm group label: Arm 2- Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ildiko Lingvay, MD, MPH, MSCS
  role: Principal Investigator
  affiliation: UT Southwestern Medical Center
  last name: Marielle Berger-Nagele, MS
  phone: 214-648-2363
  email: marielle.berger-nagele@utsouthwestern.edu
  last name: Ileana Cuevas, PhD
  phone: 214-648-2321
  email: ileana.cuevas@utsouthwestern.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Texas Southwestern Medical Center
  investigator full name: Ildiko Lingvay
  investigator title: Professor
  mesh term: Kidney Failure, Chronic
  sharing ipd: No