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/NCT06026787</url>
    </required_header>
    <id_info>
      <org_study_id>MS 419/2023</org_study_id>
      <nct_id>NCT06026787</nct_id>
    </id_info>
    <brief_title>Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome</brief_title>
    <official_title>Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</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>
        Conducted as a randomized controlled clinical trial, this study aims to assess the potential&#xD;
        benefits of incorporating dapagliflozin, an SGLT-2 inhibitor, into the treatment regimen of&#xD;
        patients diagnosed with primary nephrotic syndrome. The primary focus is on examining the&#xD;
        impact of dapagliflozin on two key parameters: proteinuria and estimated glomerular&#xD;
        filtration rate (eGFR).&#xD;
  &#xD;
        The trial involves adult participants who have been definitively diagnosed with primary&#xD;
        nephrotic syndrome through renal biopsy. In conjunction with their standard care, these&#xD;
        participants will receive a daily dose of dapagliflozin at 10 mg. Over a span of six months,&#xD;
        they will undergo comprehensive monthly assessments. These assessments will involve the&#xD;
        collection and analysis of urine samples to quantify proteinuria and perform urinalysis.&#xD;
        Additionally, blood samples will be taken to determine the estimated eGFR, lipid profile,&#xD;
        glycated hemoglobin. Participants will also be encouraged to report any potential side&#xD;
        effects resulting from their medication intake.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Actual">August 1, 2023</completion_date>
    <primary_completion_date type="Actual">August 1, 2023</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proteinuria</measure>
      <time_frame>6 months</time_frame>
      <description>Effect of dapagliflozin on proteinuria</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Estimated GFR</measure>
      <time_frame>6 months</time_frame>
    </primary_outcome>
    <other_outcome>
      <measure>Lipid profile</measure>
      <time_frame>6 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Body Weight</measure>
      <time_frame>6 months</time_frame>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Nephrotic Syndrome</condition>
    <condition>Sodium-Glucose Transporter 2 Inhibitors</condition>
    <arm_group>
      <arm_group_label>Dapagliflozin Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>During the study duration of 6 months, this cohort will be administered a daily dose of 10 mg dapagliflozin in conjunction with the standard of care for primary nephrotic syndrome based on the KDIGO 2021 guidelines. The conventional treatment regimen may encompass immunosuppressive medications, agents that block the renin-angiotensin-aldosterone system (RAAS), statins, and diuretics as deemed necessary.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Arm</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This cohort will exclusively be subjected to the standard of care tailored for primary nephrotic syndrome. This could encompass administration of immunosuppressive drugs, agents targeting the renin-angiotensin-aldosterone system (RAAS), statins, and diuretics as warranted by individual needs.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dapagliflozin 10mg Tab</intervention_name>
      <description>Dapagliflozin 10 mg will be added to the standard of care regimen of primary nephrotic syndrome patients</description>
      <arm_group_label>Dapagliflozin Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  eGFR &gt; 25 mL/min/1.73m2&#xD;
  &#xD;
            -  Evidence of primary nephrotic syndrome by renal biopsy&#xD;
  &#xD;
            -  Non-diabetic kidney disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Nephrotic syndrome secondary to lupus nephritis, AAV, amyloidosis, or secondary&#xD;
               membranous nephropathy&#xD;
  &#xD;
            -  Hepatic impairment [AST or ALT &gt;3 times ULN or total bilirubin &gt;2 times the ULN] at&#xD;
               the time of enrolment&#xD;
  &#xD;
            -  Pregnant or breast-feeding females&#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>Ain Shams University Hospitals</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</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>Nephrotic Syndrome</mesh_term>
      <mesh_term>Nephrosis</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dapagliflozin</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/NCT06026787
  org study id: MS 419/2023
  nct id: NCT06026787
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Conducted as a randomized controlled clinical trial, this study aims to assess the potential
        benefits of incorporating dapagliflozin, an SGLT-2 inhibitor, into the treatment regimen of
        patients diagnosed with primary nephrotic syndrome. The primary focus is on examining the
        impact of dapagliflozin on two key parameters: proteinuria and estimated glomerular
        filtration rate (eGFR).
  
        The trial involves adult participants who have been definitively diagnosed with primary
        nephrotic syndrome through renal biopsy. In conjunction with their standard care, these
        participants will receive a daily dose of dapagliflozin at 10 mg. Over a span of six months,
        they will undergo comprehensive monthly assessments. These assessments will involve the
        collection and analysis of urine samples to quantify proteinuria and perform urinalysis.
        Additionally, blood samples will be taken to determine the estimated eGFR, lipid profile,
        glycated hemoglobin. Participants will also be encouraged to report any potential side
        effects resulting from their medication intake.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Proteinuria
  time frame: 6 months
  description: Effect of dapagliflozin on proteinuria
  measure: Estimated GFR
  time frame: 6 months
  measure: Lipid profile
  time frame: 6 months
  measure: Body Weight
  time frame: 6 months
  arm group label: Dapagliflozin Arm
  arm group type: Experimental
  description: During the study duration of 6 months, this cohort will be administered a daily dose of 10 mg dapagliflozin in conjunction with the standard of care for primary nephrotic syndrome based on the KDIGO 2021 guidelines. The conventional treatment regimen may encompass immunosuppressive medications, agents that block the renin-angiotensin-aldosterone system (RAAS), statins, and diuretics as deemed necessary.
  arm group label: Control Arm
  arm group type: No Intervention
  description: This cohort will exclusively be subjected to the standard of care tailored for primary nephrotic syndrome. This could encompass administration of immunosuppressive drugs, agents targeting the renin-angiotensin-aldosterone system (RAAS), statins, and diuretics as warranted by individual needs.
  intervention type: Drug
  intervention name: Dapagliflozin 10mg Tab
  description: Dapagliflozin 10 mg will be added to the standard of care regimen of primary nephrotic syndrome patients
  arm group label: Dapagliflozin Arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Nephrotic Syndrome
  mesh term: Nephrosis
  mesh term: Syndrome
  mesh term: Dapagliflozin