SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients

Alexandria University

Status: Completed

Conditions: Hyperkalemia

Treatments: Drug: sodium polystyrene sulfonate; Drug: sodium zirconium cyclosilicate (SZC)

Study type: Interventional

Funder types: Other

Identifiers

NCT06029179

Hyperkalemia treatment in HD

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Group A

Active Comparator group

Description:

60 patients will receive sodium zirconium cyclosilicate (SZC)

Treatment:

Drug: sodium zirconium cyclosilicate (SZC)

Group B

Active Comparator group

Description:

60 patients will receive sodium polystyrene sulfonate

Treatment:

Drug: sodium polystyrene sulfonate