Sodium Zirconium Cyclosilicate among Individuals with Hyperkalemia: A 12-Month Phase 3 Study
Open accessAbstract
Background and objectives: Oral sodium zirconium cyclosilicate (formerly ZS-9) binds and removes potassium via the gastrointestinal tract. Sodium zirconium cyclosilicate–associated restoration and maintenance of normokalemia and adverse events were evaluated in a two-part, open label, phase 3 trial. Design, setting, participants, & measurements: In the correction phase, adult outpatients with plasma potassium ≥5.1 mmol/L (i-STAT Point-of-Care) received sodium zirconium cyclosilicate 10 g three times daily for 24–72 hours until normokalemic (potassium =3.5–5.0 mmol/L). Qualifying participants entered the ≤12-month maintenance phase and received sodium zirconium cyclosilicate 5 g once daily titrated to maintain normokalemia without dietary or medication restrictions. Prespecified primary end points were restoration of normal serum potassium values (3.5–5.0 mmol/L) during the correction phase and maintenance of serum potassium ≤5.1 mmol/L during the maintenance phase. Adverse events were assessed throughout. Results: Of 751 participants, 746 (99%) achieved normokalemia during the correction phase (mean serum potassium =4.8 mmol/L; 95% confidence interval, 4.7 to 4.8) and entered the maintenance phase; 466 (63%) participants completed the 12-month trial. Participants were predominantly white, men, and age ≥65 years old; 74% had an eGFR<60 ml/min per 1.73 m 2 , and 65% used renin-angiotensin-aldosterone system inhibitors. Mean time on sodium zirconium cyclosilicate was 286 days. Mean daily sodium zirconium cyclosilicate dose was 7.2 g (SD=2.6). Over months 3–12, mean serum potassium was 4.7 mmol/L (95% confidence interval, 4.6 to 4.7); mean serum potassium values ≤5.1 and ≤5.5 mmol/L were achieved by 88% and 99% of participants, respectively. Of 483 renin-angiotensin-aldosterone system inhibitor users at baseline, 87% continued or had their dose increased; 11% discontinued. Among 263 renin-angiotensin-aldosterone system inhibitor–naïve participants, 14% initiated renin-angiotensin-aldosterone system inhibitor therapy. Overall, 489 (66%) participants experienced adverse events during the maintenance phase, and 22% experienced a serious adverse event. Of eight (1%) deaths, none were considered related to sodium zirconium cyclosilicate. Nine (1%) and 34 (5%) participants experienced serum potassium <3.0 and 3.0–3.4 mmol/L, respectively. Conclusions: After achieving normokalemia, individualized once daily sodium zirconium cyclosilicate was associated with maintenance of normokalemia without substantial renin-angiotensin-aldosterone system inhibitor changes for ≤12 months.
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Clinical outcomes were not evaluated in the studies of potassium binders.
“However, clinical outcomes were not evaluated;”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [84]
The Study End Points section lists serum potassium measures as the primary endpoints, supporting the narrower point that clinical outcomes were not evaluated as efficacy endpoints. But the Safety section reports deaths and heart-failure hospitalizations, so the unqualified statement that clinical outcomes were not evaluated overstates what this study did. (LLM, conf=0.84)
Experimental — accuracy not yet measuredEfficacy and safety data beyond 1 year of treatment with potassium binders are not available.
“ef fi cacy and safety data beyond 1 year of treatment are not available;”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [84]
The Discussion reports efficacy and tolerability findings for sodium zirconium cyclosilicate treatment for up to 12 months. It does not state that efficacy and safety data beyond one year are unavailable for potassium binders generally; the study’s one-year duration alone does not establish that broader claim. No page number is provided in our copy. (LLM, conf=0.79)
Experimental — accuracy not yet measuredTreatment with potassium binders, such as patiromer or sodium zirconium cyclosilicate, has been used to treat hyperkalemia associated with RAS blockade therapy for up to 12 months.
“Treatment with potassium binders, such as patiromer or sodium zirconium cyclosilicate, where each has been used to treat hyperkalemia associated with RAS blockade therapy for up to 12 months. 83,84”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [84]
The Discussion reports that sodium zirconium cyclosilicate maintained normokalemia for up to 12 months without RAAS-inhibitor medication restrictions. The paper mentions patiromer as a treatment for hyperkalemia and cites a study of patients receiving RAAS inhibitors, but our copy does not establish 12-month patiromer use. (LLM, conf=0.88)
Experimental — accuracy not yet measuredBoth studies demonstrated the effectiveness of achieving normokalemia and that treatment with RAS blockade agents can be continued without treatment-related serious adverse effects.
“Both studies demonstrated the effectiveness of achieving normokalemia and that treatment with RAS blockade agents can be continued without treatment-related serious adverse effects.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [84]
The Discussion reports restoration and maintenance of normokalemia, with 74% of participants maintaining and 13% increasing their baseline RAAS-inhibitor dose. The Safety section reports serious adverse events in 22% of participants but does not establish that none were treatment-related; it says only that none of the eight deaths were considered related to SZC. This paper also reports one study, so it cannot by itself establish the claim about both studies. (LLM, conf=0.84)
Experimental — accuracy not yet measured
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- Authors
- Spinowitz, B. S., Fishbane, S., Pergola, P. E., Roger, S. D., Lerma, E. V., Butler, J., von Haehling, S., Adler, S. H., Zhao, J., Singh, B., Lavin, P. T., McCullough, P. A., Kosiborod, M., Packham, D. K., & on behalf of the ZS-005 Study Investigators
- Affiliations
- New York Hospital Queens (US)
- Hofstra University (US)
- Renal Associates PA, San Antonio, Texas;
- Gosford Hospital (AU)
- University of Illinois Chicago (US)
- University of Mississippi (US)
- Department of Cardiology and Pneumology, University Medical Center Göttingen, Göttingen, Germany;
- AstraZeneca (United States) (US)
- University of California, Irvine (US)
- Boston Biostatistics Research Foundation, Framingham, Massachusetts;
- Baylor University Medical Center (US)
- The George Institute for Global Health (AU)
- The University of Melbourne (AU)
- Corresponding author
- Spinowitz, Bruce S.
- ORCID
- Venue
- Clinical Journal of the American Society of Nephrology
- Published
- 2019-05-20
- Volume
- 14
- Issue
- 6
- Pages
- 798-809
- ISSN
- 1555-9041 (ISSN-L)
- 1555-905X
- PMC
- PMC6556727
- OpenAlex
- W2946005791
- Cited by
- 198
- References
- 27
- Citations by year
- 2026: 17 · 2025: 27 · 2024: 33 · 2023: 35 · 2022: 17 · 2021: 28 · 2020: 24 · 2019: 17
- FWCI
- 15.81
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Clinical Journal of the American Society of Nephrology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- GoeScholar The Publication Server of the Georg-August-Universität Göttingen (Georg-August-Universität Göttingen) (submittedVersion, cc-by)
- GoeScholar The Publication Server of the Georg-August-Universität Göttingen (Georg-August-Universität Göttingen) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Potassium and Related Disorders
- Health Sciences › Medicine › Nephrology › Parathyroid Disorders and Treatments
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal Regulation and Hypertension
- Keywords
- hyperkalemia, potassium homeostasis, renin-angiotensin-aldosterone system inhibitors, adverse events, hypokalemia, serum potassium, maintenance therapy, drug safety, renal potassium excretion, sodium zirconium cyclosilicate
- MeSH terms
- Adult, Aged, Humans, Hyperkalemia, Male, Potassium, Renin-Angiotensin System, Silicates
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