SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients
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ClinicalTrials.gov Identifier: NCT06029179 |
Recruitment Status :
Recruiting
First Posted : September 8, 2023
Last Update Posted : March 18, 2024
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Condition or disease | Intervention/treatment | Phase |
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Hyperkalemia | Drug: sodium zirconium cyclosilicate (SZC) Drug: sodium polystyrene sulfonate | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated 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.
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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 |
Actual Study Start Date : | January 15, 2024 |
Estimated Primary Completion Date : | May 15, 2024 |
Estimated Study Completion Date : | June 15, 2024 |
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Arm | Intervention/treatment |
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Active Comparator: Group A
30 patients will receive sodium zirconium cyclosilicate (SZC)
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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
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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. |
- Change in serum potassium [ Time Frame: 4 weeks ]By assessing serum K at baseline, 24 hrs after first dose, then weekly after the long interdialytic interval
- Change in interdialytic weight [ Time Frame: 4 weeks ]By assessing change in interdialytic weight
- Gastrointestinal side effects [ Time Frame: 4 weeks ]By reporting any GIT SE
- Change in Blood pressure [ Time Frame: 4 weeks ]systolic and diastolic Blood pressure change
- Serious adverse events [ Time Frame: 4 weeks ]By reporting any serious adverse events.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≥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.
Exclusion Criteria:
- 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.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06029179
Contact: Mohamed Mamdouh Elsayed, MD | 00201068055103 | dr_mohamedmamdouh87@yahoo.com |
Egypt | |
Faculty of Medicine, Aexandria University | Recruiting |
Alexandria, Egypt, 21526 | |
Contact: Mohamed Mamdouh Elsayed, MD 00201068055103 dr_mohamedmamdouh87@yahoo.com |
Principal Investigator: | Mohamed Mamdouh Elsayed, MD | lecturer | |
Study Chair: | Marwa Ahmed Abdelrahman, MD | consultant | |
Study Chair: | Mohamed Aly Abdelhalim, MD | Lecturer |
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: | September 8, 2023 Key Record Dates |
Last Update Posted: | March 18, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hyperkalemia Hemodialysis Sodium Zirconium Cyclosilicate Sodium Polystyrene Sulfonate |
Hyperkalemia Water-Electrolyte Imbalance Metabolic Diseases Polystyrene sulfonic acid |
Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |