SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-12-15

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.

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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.

Conditions

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Hyperkalemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

60 patients will receive sodium zirconium cyclosilicate (SZC)

Group Type ACTIVE_COMPARATOR

sodium zirconium cyclosilicate (SZC)

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

sodium polystyrene sulfonate

Intervention Type DRUG

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

Interventions

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sodium zirconium cyclosilicate (SZC)

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

Intervention Type DRUG

sodium polystyrene sulfonate

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No