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/NCT06029179</url>
    </required_header>
    <id_info>
      <org_study_id>Hyperkalemia treatment in HD</org_study_id>
      <nct_id>NCT06029179</nct_id>
    </id_info>
    <brief_title>SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients</brief_title>
    <official_title>Sodium Zirconium Cyclosilicate Versus Sodium Polystyrene Sulfonate for Treatment of Hyperkalemia in Hemodialysis Patients: A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexandria University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to compare the effects of Sodium Zirconium Cyclosilicate versus Sodium&#xD;
        Polystyrene Sulfonate for treatment of hyperkalemia in patients undergoing regular&#xD;
        hemodialysis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients maintained on regular hemodialysis (HD) have a high risk of hyperkalemia (&gt;5.0&#xD;
        mmol/l). Hyperkalemia is a critical medical condition that can result in arrhythmias and&#xD;
        sudden cardiac death. Treatment of hyperkalemia in HD patients is challenging.&#xD;
  &#xD;
        Therapeutic options for the treatment of hyperkalemia in HD population include potassium&#xD;
        binding resins, such as sodium polystyrene sulfonate (SPS), patiromer, and sodium zirconium&#xD;
        cyclosilicate. There is limited data about the use of these agents in HD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 15, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 15, 2023</primary_completion_date>
    <phase>N/A</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 research is a prospective randomized multicentric clinical trial in which 60 hemodialysis patients will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1.&#xD;
  Group A: 30 patients will receive sodium zirconium cyclosilicate (SZC) 5 g once daily on non-dialysis days (15 gm/week) for 4 weeks.&#xD;
  Group B: 30 patients will receive sodium polystyrene sulfonate 15 g once daily on non-dialysis days (45 gm/week) for 4 weeks.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in serum potassium</measure>
      <time_frame>4 weeks</time_frame>
      <description>By assessing serum K at baseline, 24 hrs after first dose, then weekly after the long interdialytic interval</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in interdialytic weight</measure>
      <time_frame>4 weeks</time_frame>
      <description>By assessing change in interdialytic weight</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gastrointestinal side effects</measure>
      <time_frame>4 weeks</time_frame>
      <description>By reporting any GIT SE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Blood pressure</measure>
      <time_frame>4 weeks</time_frame>
      <description>systolic and diastolic Blood pressure change</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serious adverse events</measure>
      <time_frame>4 weeks</time_frame>
      <description>By reporting any serious adverse events.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Hyperkalemia</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>30 patients will receive sodium zirconium cyclosilicate (SZC)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>30 patients will receive sodium polystyrene sulfonate</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>sodium zirconium cyclosilicate (SZC)</intervention_name>
      <description>30 patients will receive sodium zirconium cyclosilicate (SZC) 5 g once daily on non-dialysis days (15 gm/week) for 4 weeks.</description>
      <arm_group_label>Group A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>sodium polystyrene sulfonate</intervention_name>
      <description>30 patients will receive sodium polystyrene sulfonate 15 g once daily on non-dialysis days (45 gm/week) for 4 weeks.</description>
      <arm_group_label>Group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. ≥3 month of maintenance hemodialysis, 3 times per week for 4 hours.&#xD;
  &#xD;
            2. Adult patients with age above 18 years.&#xD;
  &#xD;
            3. baseline serum potassium level &gt;5 mEq/L.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Gastrointestinal diseases (constipation, bleeding, Hx of endoscopy, chronic diarrhea&#xD;
               or diarrhea in the past month, malabsorption, GIT surgery, ischemic colitis, necrosis,&#xD;
               perforation, ….).&#xD;
  &#xD;
            2. Breast feeding or pregnancy.&#xD;
  &#xD;
            3. Patients who receive medications to treat hyperkalemia 2 weeks before study.&#xD;
  &#xD;
            4. myocardial infarction, acute coronary syndrome, stroke, seizure, or thromboembolic&#xD;
               event within 8 weeks before 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>Mohamed Mamdouh Elsayed, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>lecturer</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Marwa Ahmed Abdelrahman, MD</last_name>
      <role>Study Chair</role>
      <affiliation>consultant</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mohamed Aly Abdelhalim, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Lecturer</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mohamed Mamdouh Elsayed, MD</last_name>
      <phone>00201068055103</phone>
      <email>dr_mohamedmamdouh87@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of Medicine, Aexandria University</name>
        <address>
          <city>Alexandria</city>
          <zip>21526</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Mohamed Mamdouh Elsayed, MD</last_name>
        <phone>00201068055103</phone>
        <email>dr_mohamedmamdouh87@yahoo.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Yusuf AA, Hu Y, Singh B, Menoyo JA, Wetmore JB. Serum Potassium Levels and Mortality in Hemodialysis Patients: A Retrospective Cohort Study. Am J Nephrol. 2016;44(3):179-86. doi: 10.1159/000448341. Epub 2016 Sep 3.</citation>
      <PMID>27592170</PMID>
    </reference>
    <reference>
      <citation>Hoppe LK, Muhlack DC, Koenig W, Carr PR, Brenner H, Schottker B. Association of Abnormal Serum Potassium Levels with Arrhythmias and Cardiovascular Mortality: a Systematic Review and Meta-Analysis of Observational Studies. Cardiovasc Drugs Ther. 2018 Apr;32(2):197-212. doi: 10.1007/s10557-018-6783-0.</citation>
      <PMID>29679302</PMID>
    </reference>
    <reference>
      <citation>Beccari MV, Meaney CJ. Clinical utility of patiromer, sodium zirconium cyclosilicate, and sodium polystyrene sulfonate for the treatment of hyperkalemia: an evidence-based review. Core Evid. 2017 Mar 23;12:11-24. doi: 10.2147/CE.S129555. eCollection 2017. Erratum In: Core Evid. 2019 Feb 27;14:1.</citation>
      <PMID>28356904</PMID>
    </reference>
    <reference>
      <citation>Fried L, Kovesdy CP, Palmer BF. New options for the management of chronic hyperkalemia. Kidney Int Suppl (2011). 2017 Dec;7(3):164-170. doi: 10.1016/j.kisu.2017.09.001. Epub 2017 Nov 17.</citation>
      <PMID>30675431</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Alexandria University</investigator_affiliation>
      <investigator_full_name>Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>Hyperkalemia</keyword>
    <keyword>Hemodialysis</keyword>
    <keyword>Sodium Zirconium Cyclosilicate</keyword>
    <keyword>Sodium Polystyrene Sulfonate</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyperkalemia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Polystyrene sulfonic acid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06029179
  org study id: Hyperkalemia treatment in HD
  nct id: NCT06029179
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to compare the effects of Sodium Zirconium Cyclosilicate versus Sodium
        Polystyrene Sulfonate for treatment of hyperkalemia in patients undergoing regular
        hemodialysis.
  Patients maintained on regular hemodialysis (HD) have a high risk of hyperkalemia (>5.0
        mmol/l). Hyperkalemia is a critical medical condition that can result in arrhythmias and
        sudden cardiac death. Treatment of hyperkalemia in HD patients is challenging.
  
        Therapeutic options for the treatment of hyperkalemia in HD population include potassium
        binding resins, such as sodium polystyrene sulfonate (SPS), patiromer, and sodium zirconium
        cyclosilicate. There is limited data about the use of these agents in HD.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This research is a prospective randomized multicentric clinical trial in which 60 hemodialysis patients will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1.
  Group A: 30 patients will receive sodium zirconium cyclosilicate (SZC) 5 g once daily on non-dialysis days (15 gm/week) for 4 weeks.
  Group B: 30 patients will receive sodium polystyrene sulfonate 15 g once daily on non-dialysis days (45 gm/week) for 4 weeks.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in serum potassium
  time frame: 4 weeks
  description: By assessing serum K at baseline, 24 hrs after first dose, then weekly after the long interdialytic interval
  measure: Change in interdialytic weight
  time frame: 4 weeks
  description: By assessing change in interdialytic weight
  measure: Gastrointestinal side effects
  time frame: 4 weeks
  description: By reporting any GIT SE
  measure: Change in Blood pressure
  time frame: 4 weeks
  description: systolic and diastolic Blood pressure change
  measure: Serious adverse events
  time frame: 4 weeks
  description: By reporting any serious adverse events.
  arm group label: Group A
  arm group type: Active Comparator
  description: 30 patients will receive sodium zirconium cyclosilicate (SZC)
  arm group label: Group B
  arm group type: Active Comparator
  description: 30 patients will receive sodium polystyrene sulfonate
  intervention type: Drug
  intervention name: sodium zirconium cyclosilicate (SZC)
  description: 30 patients will receive sodium zirconium cyclosilicate (SZC) 5 g once daily on non-dialysis days (15 gm/week) for 4 weeks.
  arm group label: Group A
  intervention type: Drug
  intervention name: sodium polystyrene sulfonate
  description: 30 patients will receive sodium polystyrene sulfonate 15 g once daily on non-dialysis days (45 gm/week) for 4 weeks.
  arm group label: Group B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mohamed Mamdouh Elsayed, MD
  role: Principal Investigator
  affiliation: lecturer
  last name: Marwa Ahmed Abdelrahman, MD
  role: Study Chair
  affiliation: consultant
  last name: Mohamed Aly Abdelhalim, MD
  role: Study Chair
  affiliation: Lecturer
  last name: Mohamed Mamdouh Elsayed, MD
  phone: 00201068055103
  email: dr_mohamedmamdouh87@yahoo.com
  facility: 
  contact: 
  country: Egypt
  citation: Yusuf AA, Hu Y, Singh B, Menoyo JA, Wetmore JB. Serum Potassium Levels and Mortality in Hemodialysis Patients: A Retrospective Cohort Study. Am J Nephrol. 2016;44(3):179-86. doi: 10.1159/000448341. Epub 2016 Sep 3.
  PMID: 27592170
  citation: Hoppe LK, Muhlack DC, Koenig W, Carr PR, Brenner H, Schottker B. Association of Abnormal Serum Potassium Levels with Arrhythmias and Cardiovascular Mortality: a Systematic Review and Meta-Analysis of Observational Studies. Cardiovasc Drugs Ther. 2018 Apr;32(2):197-212. doi: 10.1007/s10557-018-6783-0.
  PMID: 29679302
  citation: Beccari MV, Meaney CJ. Clinical utility of patiromer, sodium zirconium cyclosilicate, and sodium polystyrene sulfonate for the treatment of hyperkalemia: an evidence-based review. Core Evid. 2017 Mar 23;12:11-24. doi: 10.2147/CE.S129555. eCollection 2017. Erratum In: Core Evid. 2019 Feb 27;14:1.
  PMID: 28356904
  citation: Fried L, Kovesdy CP, Palmer BF. New options for the management of chronic hyperkalemia. Kidney Int Suppl (2011). 2017 Dec;7(3):164-170. doi: 10.1016/j.kisu.2017.09.001. Epub 2017 Nov 17.
  PMID: 30675431
  responsible party type: Principal Investigator
  investigator affiliation: Alexandria University
  investigator full name: Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD
  investigator title: Lecturer
  mesh term: Hyperkalemia
  mesh term: Polystyrene sulfonic acid
  sharing ipd: Undecided