Skip to main content
OpenTrials
Completed

NCT Number: NCT06029179

SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperkalemia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Aexandria University

Alexandria, 21526, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Sodium Zirconium Cyclosilicate (SZC)

Drug

60 patients will receive sodium zirconium cyclosilicate (SZC) 5 g once daily on non-dialysis days (15 gm/week) for 8 weeks.

Sodium polystyrene sulfonate

Drug

60 patients will receive sodium polystyrene sulfonate 15 g once daily on non-dialysis days (45 gm/week) for 8 weeks.

Primary outcomes

  1. Change in serum potassium

    Time frame: 8 weeks

    By assessing serum K at baseline, 24 hrs after first dose, then weekly after the long interdialytic interval

Secondary outcomes

  1. Change in interdialytic weight

    Time frame: 8 weeks

    By assessing change in interdialytic weight

  2. Gastrointestinal side effects

    Time frame: 8 weeks

    By reporting any GIT SE

  3. Change in Blood pressure

    Time frame: 8 weeks

    systolic and diastolic Blood pressure change

  4. Serious adverse events

    Time frame: 8 weeks

    By reporting any serious adverse events.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Sodium Zirconium Cyclosilicate Versus Sodium Polystyrene Sulfonate for Treatment of Hyperkalemia in Hemodialysis Patients: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 8, 2023
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.