SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hyperkalemia

Intervention / Treatment
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* Drug: sodium zirconium cyclosilicate (SZC)
* Drug: sodium polystyrene sulfonate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>30 patients will receive sodium zirconium cyclosilicate (SZC) | Drug: sodium zirconium cyclosilicate (SZC)<br>* 30 patients will receive sodium zirconium cyclosilicate (SZC) 5 g once daily on non-dialysis days (15 gm/week) for 4 weeks.<br>|
| Active Comparator: Group B<br>30 patients will receive sodium polystyrene sulfonate | Drug: sodium polystyrene sulfonate<br>* 30 patients will receive sodium polystyrene sulfonate 15 g once daily on non-dialysis days (45 gm/week) for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperkalemia, Hemodialysis, Sodium Zirconium Cyclosilicate, Sodium Polystyrene Sulfonate