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The randomized DIALIZE-Outcomes trial evaluated sodium zirconium cyclosilicate in hemodialysis

Steven Fishbane1, Laura M Dember2, Michel Jadoul3

  • 1Division of Nephrology, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA.

Kidney International
|July 6, 2025
PubMed

Insights

Sodium zirconium cyclosilicate (SZC) did not reduce cardiovascular events in hemodialysis patients with hyperkalemia, despite effectively controlling serum potassium levels. Further research is needed to clarify its role in managing kidney disease complications.

Area of Science:

  • Nephrology
  • Cardiology
  • Clinical Trials

Background:

  • Maintenance hemodialysis patients often have predialysis hyperkalemia, increasing arrhythmia and cardiovascular risks.
  • The DIALIZE-Outcomes trial investigated sodium zirconium cyclosilicate (SZC) for these outcomes.

Purpose of the Study:

  • To evaluate the efficacy of sodium zirconium cyclosilicate (SZC) in reducing arrhythmia-related cardiovascular events in hemodialysis patients.
  • To assess SZC's effect on serum potassium control and overall cardiovascular safety.

Main Methods:

  • Adult hemodialysis patients with hyperkalemia (serum potassium ≥5.5 mmol/l) were randomized to SZC or placebo.
  • The primary endpoint was a composite of sudden cardiac death, stroke, or arrhythmia-related hospitalizations/interventions.
  • SZC dosage was titrated weekly to achieve normokalemia (4.0-5.0 mmol/l).

Main Results:

  • The trial was terminated early due to low event rates and high discontinuation.
  • SZC showed no significant effect on the primary composite cardiovascular endpoint (HR 0.98; 95% CI 0.76-1.26).
  • SZC significantly improved normokalemia maintenance (74.0% vs. 47.0%; OR 3.36) but had higher rates of hypokalemia (3.0% vs. 1.4%).

Conclusions:

  • Sodium zirconium cyclosilicate (SZC) did not demonstrate a benefit for arrhythmia-related cardiovascular outcomes in this population.
  • Despite its efficacy in serum potassium normalization, SZC's clinical utility for preventing major cardiovascular events remains unproven.
Abstract

Keywords:
cardiovascular diseasechronic kidney diseasehemodialysis

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