SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients

NCT06029179 | Completed

• 1 other identifier: Hyperkalemia treatment in HD
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperkalemia

Keywords

Hyperkalemia; Hemodialysis; Sodium Zirconium Cyclosilicate; Sodium Polystyrene Sulfonate

Outcome Measures

Primary Outcomes (1)

• Change in serum potassium

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

  8 weeks

Secondary Outcomes (4)

• Change in interdialytic weight

  8 weeks

• Gastrointestinal side effects

  8 weeks

• Change in Blood pressure

  8 weeks

• Serious adverse events

  8 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

60 patients will receive sodium zirconium cyclosilicate (SZC)

Drug: sodium zirconium cyclosilicate (SZC)

Group B

ACTIVE COMPARATOR

60 patients will receive sodium polystyrene sulfonate

Drug: sodium polystyrene sulfonate

Interventions

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.

Group A

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.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine, Aexandria University

Alexandria, 21526, Egypt

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 28356904 BACKGROUND

• 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 BACKGROUND

• Elsayed MM, Abdelrahman MA, Sorour AM, Rizk IG, Hassab MAA. Sodium zirconium cyclosilicate versus sodium polystyrene sulfonate for treatment of hyperkalemia in hemodialysis patients: a randomized clinical trial. BMC Nephrol. 2025 May 6;26(1):227. doi: 10.1186/s12882-025-04129-9.

  PMID: 40329202 DERIVED

MeSH Terms

Conditions

Hyperkalemia

Interventions

sodium zirconium cyclosilicate; polystyrene sulfonic acid

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mohamed Mamdouh Elsayed, MD

  lecturer

  PRINCIPAL INVESTIGATOR

• Marwa Ahmed Abdelrahman, MD

  consultant

  STUDY CHAIR

• Mohamed Aly Abdelhalim, MD

  Lecturer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This research is a prospective randomized multicentric clinical trial in which 120 hemodialysis patients will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1. * Group A: 60 patients will receive sodium zirconium cyclosilicate (SZC) 5 g once daily on non-dialysis days (15 gm/week) for 8 weeks. * Group B: 60 patients will receive sodium polystyrene sulfonate 15 g once daily on non-dialysis days (45 gm/week) for 8 weeks.

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: January 15, 2024
• Primary Completion: October 15, 2024
• Study Completion: December 15, 2024
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

EG (1)