SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients

• Sponsor: Alexandria University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06029179
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 2
• Patients Per Site Per Month: 29.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperkalemia	Drug: sodium zirconium cyclosilicate (SZC); Drug: sodium polystyrene sulfonate	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: Sodium Zirconium Cyclosilicate Versus Sodium Polystyrene Sulfonate for Treatment of Hyperkalemia in Hemodialysis Patients: A Randomized Clinical Trial
• Anticipated Study Start Date: Oct 15, 2023
• Anticipated Primary Completion Date: Nov 15, 2023
• Anticipated Study Completion Date: Dec 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in serum potassium [4 weeks]

   By assessing serum K at baseline, 24 hrs after first dose, then weekly after the long interdialytic interval

Secondary Outcome Measures

1. Change in interdialytic weight [4 weeks]

   By assessing change in interdialytic weight

2. Gastrointestinal side effects [4 weeks]

   By reporting any GIT SE

3. Change in Blood pressure [4 weeks]

   systolic and diastolic Blood pressure change

4. Serious adverse events [4 weeks]

   By reporting any serious adverse events.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Aexandria University	Alexandria		Egypt	21526

Sponsors and Collaborators

• Alexandria University

Investigators

• Principal Investigator: Mohamed Mamdouh Elsayed, MD, lecturer
• Study Chair: Marwa Ahmed Abdelrahman, MD, consultant
• Study Chair: Mohamed Aly Abdelhalim, MD, Lecturer

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Lecturer, Alexandria University
• ClinicalTrials.gov Identifier: NCT06029179
• Other Study ID Numbers: Hyperkalemia treatment in HD
• First Posted: Sep 8, 2023
• Last Update Posted: Sep 11, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Lecturer, Alexandria University: Hyperkalemia; Hemodialysis; Sodium Zirconium Cyclosilicate; Sodium Polystyrene Sulfonate
• Additional relevant MeSH terms: Hyperkalemia; Polystyrene sulfonic acid

Study Results

No Results Posted as of Sep 11, 2023