SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients

Hyperkalemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029179
• Other study ID #: Hyperkalemia treatment in HD
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: June 15, 2024

Study information

• Verified date: March 2024
• Source: Alexandria University
• Contact: Mohamed Mamdouh Elsayed, MD
• Phone: 00201068055103
• Email: dr_mohamedmamdouh87[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperkalemia

Intervention

Drug:
• sodium zirconium cyclosilicate (SZC)
30 patients will receive sodium zirconium cyclosilicate (SZC) 5 g once daily on non-dialysis days (15 gm/week) for 4 weeks.
• sodium polystyrene sulfonate
30 patients will receive sodium polystyrene sulfonate 15 g once daily on non-dialysis days (45 gm/week) for 4 weeks.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Aexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. Erratum In: Core Evid. 2019 Feb 27;14:1. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in interdialytic weight	By assessing change in interdialytic weight	4 weeks
Secondary	Gastrointestinal side effects	By reporting any GIT SE	4 weeks
Secondary	Change in Blood pressure	systolic and diastolic Blood pressure change	4 weeks
Secondary	Serious adverse events	By reporting any serious adverse events.	4 weeks