HyperkalemiaNCT06029179
SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients
A study testing sodium zirconium cyclosilicate (SZC) and sodium polystyrene sulfonate in people with Hyperkalemia, run by Alexandria University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- sodium zirconium cyclosilicate (SZC) and sodium polystyrene sulfonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2024to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sodium Zirconium Cyclosilicate Versus Sodium Polystyrene Sulfonate for Treatment of Hyperkalemia in Hemodialysis Patients: A Randomized Clinical Trial
This study aims to compare the effects of Sodium Zirconium Cyclosilicate versus Sodium Polystyrene Sulfonate for treatment of hyperkalemia in patients undergoing regular hemodialysis.
Read the 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.
- Conditions
- Hyperkalemia
- Being tested
- sodium zirconium cyclosilicate (SZC), sodium polystyrene sulfonate
- Keywords
- Hyperkalemia, Hemodialysis, Sodium Zirconium Cyclosilicate, Sodium Polystyrene Sulfonate
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium zirconium cyclosilicate (SZC)Drug
60 patients will receive sodium zirconium cyclosilicate (SZC) 5 g once daily on non-dialysis days (15 gm/week) for 8 weeks.
sodium polystyrene sulfonateDrug
60 patients will receive sodium polystyrene sulfonate 15 g once daily on non-dialysis days (45 gm/week) for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 60 patients will receive sodium zirconium cyclosilicate (SZC) Receives: Drug: sodium zirconium cyclosilicate (SZC) |
| Group B | Active comparator | 60 patients will receive sodium polystyrene sulfonate Receives: Drug: sodium polystyrene sulfonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum potassium
By assessing serum K at baseline, 24 hrs after first dose, then weekly after the long interdialytic interval
Measured: 8 weeks
Secondary outcomes (4)
Change in interdialytic weight
By assessing change in interdialytic weight
Measured: 8 weeks
Gastrointestinal side effects
By reporting any GIT SE
Measured: 8 weeks
Change in Blood pressure
systolic and diastolic Blood pressure change
Measured: 8 weeks
Serious adverse events
By reporting any serious adverse events.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start15 Jan 2024
- Primary completion15 Oct 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University
- Investigators
- Mohamed Mamdouh Elsayed, MD, Principal investigator, lecturerMarwa Ahmed Abdelrahman, MD, Study chair, consultantMohamed Aly Abdelhalim, MD, Study chair, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029179
- Sponsor's protocol ID
- Hyperkalemia treatment in HD
- Status last verified
- Feb 2025
- First submitted
- 1 Sep 2023
- Last updated
- 11 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27592170Hoppe 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.
PubMed 29679302Beccari 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.
PubMed 28356904Fried 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.
PubMed 30675431Elsayed MM, Abdelrahman MA, Sorour AM, Rizk IG, Hassab MAA. Sodium zirconium cyclosilicate versus sodium polystyrene sulfonate for treatment of hyperkalemia in hemodialysis patients: a randomized clinical trial. BMC Nephrol. 2025 May 6;26(1):227. doi: 10.1186/s12882-025-04129-9.
PubMed 40329202
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Zirconium Cyclosilicate Versus Sodium Polystyrene Sulfonate for Treatment of Hyperkalemia in Hemodialysis Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06029179
- Acronym / sponsor ID
- Hyperkalemia treatment in HD
- Conditions
- Hyperkalemia
- Keywords
- Hyperkalemia, Hemodialysis, Sodium Zirconium Cyclosilicate, Sodium Polystyrene Sulfonate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: sodium zirconium cyclosilicate (SZC)60 patients will receive sodium zirconium cyclosilicate (SZC) |
| Group B | Active comparator | Drug: sodium polystyrene sulfonate60 patients will receive sodium polystyrene sulfonate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Group A |
| sodium polystyrene sulfonate60 patients will receive sodium polystyrene sulfonate 15 g once daily on non-dialysis days (45 gm/week) for 8 weeks. | Drug | Group B |
Primary outcome
Change in serum potassium
Time frame: 8 weeks
By assessing serum K at baseline, 24 hrs after first dose, then weekly after the long interdialytic interval
4 secondary outcomes
Change in interdialytic weight
Time frame: 8 weeks
Gastrointestinal side effects
Time frame: 8 weeks
Change in Blood pressure
Time frame: 8 weeks
Serious adverse events
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Background: PubMed 27592170Yusuf 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.
- Background: PubMed 29679302Hoppe 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.
- Background: PubMed 28356904Beccari 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.
- Background: PubMed 30675431Fried 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.
- Derived from this study: PubMed 40329202Elsayed MM, Abdelrahman MA, Sorour AM, Rizk IG, Hassab MAA. Sodium zirconium cyclosilicate versus sodium polystyrene sulfonate for treatment of hyperkalemia in hemodialysis patients: a randomized clinical trial. BMC Nephrol. 2025 May 6;26(1):227. doi: 10.1186/s12882-025-04129-9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Mamdouh Elsayed, MD principal investigator
lecturer
Marwa Ahmed Abdelrahman, MD study chair
consultant
Mohamed Aly Abdelhalim, MD study chair
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sodium zirconium cyclosilicate (SZC) and sodium polystyrene sulfonate in people with Hyperkalemia, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum potassium (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06029179, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.