SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients

Not Applicable

Completed

• Conditions: Hyperkalemia
• Interventions: Drug: sodium zirconium cyclosilicate (SZC); Drug: sodium polystyrene sulfonate

• Registration Number: NCT06029179
• Lead Sponsor: Alexandria University

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.

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 Timeline

• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-01
• Study First Posted: 2023-09-08
• Study Start: 2024-01-15
• Primary Completion: 2024-10-15
• Study Completion: 2024-12-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	sodium zirconium cyclosilicate (SZC)	60 patients will receive sodium zirconium cyclosilicate (SZC)
Group B	sodium polystyrene sulfonate	60 patients will receive sodium polystyrene sulfonate

Primary Outcome Measures

Name	Time	Method
Change in serum potassium	8 weeks	By assessing serum K at baseline, 24 hrs after first dose, then weekly after the long interdialytic interval

Secondary Outcome Measures

Name	Time	Method
Change in interdialytic weight	8 weeks	By assessing change in interdialytic weight
Gastrointestinal side effects	8 weeks	By reporting any GIT SE
Change in Blood pressure	8 weeks	systolic and diastolic Blood pressure change
Serious adverse events	8 weeks	By reporting any serious adverse events.

Trial Locations

Locations (1)

Faculty of Medicine, Aexandria University; 🇪🇬 Alexandria, Egypt