SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients

March 15, 2024 updated by: Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt, 21526
        • Recruiting
        • Faculty of Medicine, Aexandria University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in interdialytic weight
Time Frame: 4 weeks
By assessing change in interdialytic weight
4 weeks
Gastrointestinal side effects
Time Frame: 4 weeks
By reporting any GIT SE
4 weeks
Change in Blood pressure
Time Frame: 4 weeks
systolic and diastolic Blood pressure change
4 weeks
Serious adverse events
Time Frame: 4 weeks
By reporting any serious adverse events.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Mohamed Mamdouh Elsayed, MD, lecturer
  • Study Chair: Marwa Ahmed Abdelrahman, MD, Consultant
  • Study Chair: Mohamed Aly Abdelhalim, MD, lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

May 15, 2024

Study Completion (Estimated)

June 15, 2024

Study Registration Dates

First Submitted

September 1, 2023

First Submitted That Met QC Criteria

September 1, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hyperkalemia treatment in HD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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