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SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT06029179
Recruitment Status : Recruiting
First Posted : September 8, 2023
Last Update Posted : March 18, 2024
Sponsor:
Information provided by (Responsible Party):
Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University

Study Description
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Brief Summary:
This study aims to compare the effects of Sodium Zirconium Cyclosilicate versus Sodium Polystyrene Sulfonate for treatment of hyperkalemia in patients undergoing regular hemodialysis.

Condition or disease Intervention/treatment Phase
Hyperkalemia Drug: sodium zirconium cyclosilicate (SZC) Drug: sodium polystyrene sulfonate Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sodium Zirconium Cyclosilicate Versus Sodium Polystyrene Sulfonate for Treatment of Hyperkalemia in Hemodialysis Patients: A Randomized Clinical Trial
Actual Study Start Date : January 15, 2024
Estimated Primary Completion Date : May 15, 2024
Estimated Study Completion Date : June 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group A
30 patients will receive sodium zirconium cyclosilicate (SZC)
 Drug: sodium zirconium cyclosilicate (SZC)
30 patients will receive sodium zirconium cyclosilicate (SZC) 5 g once daily on non-dialysis days (15 gm/week) for 4 weeks.
Active Comparator: Group B
30 patients will receive sodium polystyrene sulfonate
 Drug: sodium polystyrene sulfonate
30 patients will receive sodium polystyrene sulfonate 15 g once daily on non-dialysis days (45 gm/week) for 4 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Change in serum potassium [ Time Frame: 4 weeks ]
    By assessing serum K at baseline, 24 hrs after first dose, then weekly after the long interdialytic interval


Secondary Outcome Measures :
  1. Change in interdialytic weight [ Time Frame: 4 weeks ]
    By assessing change in interdialytic weight

  2. Gastrointestinal side effects [ Time Frame: 4 weeks ]
    By reporting any GIT SE

  3. Change in Blood pressure [ Time Frame: 4 weeks ]
    systolic and diastolic Blood pressure change

  4. Serious adverse events [ Time Frame: 4 weeks ]
    By reporting any serious adverse events.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥3 month of maintenance hemodialysis, 3 times per week for 4 hours.
  2. Adult patients with age above 18 years.
  3. baseline serum potassium level >5 mEq/L.

Exclusion Criteria:

  1. Gastrointestinal diseases (constipation, bleeding, Hx of endoscopy, chronic diarrhea or diarrhea in the past month, malabsorption, GIT surgery, ischemic colitis, necrosis, perforation, ….).
  2. Breast feeding or pregnancy.
  3. Patients who receive medications to treat hyperkalemia 2 weeks before study.
  4. myocardial infarction, acute coronary syndrome, stroke, seizure, or thromboembolic event within 8 weeks before study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06029179


Contacts
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Contact: Mohamed Mamdouh Elsayed, MD 00201068055103 dr_mohamedmamdouh87@yahoo.com

Locations
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Egypt
Faculty of Medicine, Aexandria University Recruiting
Alexandria, Egypt, 21526
Contact: Mohamed Mamdouh Elsayed, MD    00201068055103    dr_mohamedmamdouh87@yahoo.com   
Sponsors and Collaborators
Alexandria University
Investigators
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Principal Investigator: Mohamed Mamdouh Elsayed, MD lecturer
Study Chair: Marwa Ahmed Abdelrahman, MD consultant
Study Chair: Mohamed Aly Abdelhalim, MD Lecturer
More Information
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Publications:

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Responsible Party: Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Lecturer, Alexandria University
ClinicalTrials.gov Identifier: NCT06029179    
Other Study ID Numbers: Hyperkalemia treatment in HD
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: March 18, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University:
Hyperkalemia
Hemodialysis
Sodium Zirconium Cyclosilicate
Sodium Polystyrene Sulfonate
Additional relevant MeSH terms:
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Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases
Polystyrene sulfonic acid
 Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action