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.

Patients with kidney failure receiving chronic haemodialysis have elevated risk of arrhythmias potentially increasing the likelihood of sudden cardiac death, stroke and hospitalisation. The DIALIZE study (NCT03303521) demonstrated that sodium zirconium cyclosilicate (SZC) was an efficacious and well-tolerated treatment for predialysis hyperkalaemia in patients undergoing haemodialysis. The DIALIZE-Outcomes study evaluates the effect of SZC on sudden cardiac death and arrhythmia-related cardiovascular outcomes in patients receiving chronic haemodialysis with recurrent hyperkalaemia. International, multicentre, randomised, double-blind, placebo-controlled study conducted at 357 study sites across 25 countries. Adults (≥18 years) receiving chronic haemodialysis three times per week with recurrent predialysis serum potassium (K Approval was obtained from the relevant institutional review board/independent ethics committee from each participating site (approving bodies in supplementary information). The results will be submitted to a peer-reviewed journal. EudraCT 2020-005561-14 and clinicaltrials.gov identifier NCT04847232.

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Competing interests: SF received research support and consulting fees from AstraZeneca. MJ received research support and consulting fees from AstraZeneca and consulting fees from Vifor Fresenius Medical Care Renal Pharma. LD received consulting fees from AstraZeneca, Cara Therapeutics,CSL Behring, Merck and Vertex, and received compensation from the National Kidney Foundation for her role as a Deputy Editor of the American Journal of Kidney Diseases. CPK received consulting fees from Abbott, Akebia, AstraZeneca, Bayer, Boehringer Ingelheim, CSL Behring, GSK, Rockwell and Vifor. AA-S, VL, PS, BK and NG are employees of, and hold or may hold stock in, AstraZeneca. CH received personal fees (consultancy) from AstraZeneca, Bayer, Bristol Myers Squibb, DiaMedica, FibroGen, Merck, NxStage, Pfizer, Relypsa and the University of Oxford; grants from the University of British Columbia, Bristol Myers Squibb and the National Institutes of Health (National Institute of Diabetes and Digestive and Kidney Diseases and National Heart, Lung, and Blood Institute); and author royalties from UpToDate. CH reports stock ownership in Johnson & Johnson, Merck and Pfizer and is employed by Hennepin Healthcare.