Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)

Summary

The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC) on arrhythmia-related cardiovascular outcomes in participants on chronic hemodialysis with recurrent hyperkalemia.

Timeline

Start

2021-04-30

Primary completion

2024-03-07

Completion

2024-03-07

Outcome

Missed primary endpoint

Stopped: “The event rate observed in the study continued to be below primary assumptions, so that the completion of the study within a reasonable timeframe was deemed very unlikely.”

paper No treatment effect was observed on the primary composite end point (SZC, 8.8% [119 patients] vs. placebo, 8.9% [119 patients]; hazard ratio 0.98; 95% confidence interval 0.76-1.26) PMID 40618849 ↗

registry p = 0.867; Hazard Ratio (HR) 0.98 (95% CI 0.76 to 1.26) NCT04847232 ↗

Publications

• Fishbane S, Dember LM, Jadoul M, Kovesdy CP, Guzman N, Kordzakhia G, Lisovskaja V, Sekar P, Wessman P, Al-Shurbaji A, Herzog CA. The randomized DIALIZE-Outcomes trial evaluated sodium zirconium cyclosilicate in hemodialysis. Kidney Int. 2025 Oct;108(4):686-694. doi: 10.1016/j.kint.2025.06.016. Epub 2025 Jul 4.
• Fishbane S, Jadoul M, Dember L, Kovesdy CP, Al-Shurbaji A, Lisovskaja V, Sekar P, Katona B, Guzman N, Herzog C. Evaluation of the effect of sodium zirconium cyclosilicate on arrhythmia-related cardiovascular outcomes in patients receiving chronic haemodialysis with hyperkalaemia: protocol for the multicentre, randomised, controlled DIALIZE-Outcomes study. BMJ Open. 2023 May 25;13(5):e071309. doi: 10.1136/bmjopen-2022-071309.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sodium Zirconium Cyclosilicate	Other / unclassified	—	Oral

Indications

No indication recorded.