Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
TerminatedPhase 3Results postedLast updated 18 June 2025
What this trial tests
Phase 3 trial testing Sodium Zirconium Cyclosilicate (SZC) in Hyperkalemia in 2,690 participants. Terminated before completion.
Adults 18 to 130, any sex, with Hyperkalemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of the Composite of Cardiac Event OutcomesPrimary· From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Incidence of the composite endpoint of SCD, all stroke, or hospitalization/intervention/emergency department (ED) visit due to arrhythmias is analyzed based on Cox regression model with treatment and region as covariates. Patients with no events are censored at final clinical assessment, death, or disposition event.
Group
Value
95% CI
SZC (Active)
119
Placebo
119
Normokalemia at 12 Months Post-randomizationSecondary· Randomization to 12-Month Visit
Logistic regression analysis of whether a subject is Normokalemic (S-K of 4.0 - 5.5 mmol/L ) after the LIDI at the 12-month visit.
Group
Value
95% CI
SZC (Active)
495
Placebo
293
Incidence of the Composite of Arrhythmia Related EventsSecondary· From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Incidence of the composite endpoint of hospitalization, intervention, emergency department (ED) visit due to arrhythmias is analyzed based on Cox regression model with treatment and region as covariates. Patients with no events are censored at final clinical assessment, death, or disposition event.
Group
Value
95% CI
SZC (Active)
74
Placebo
65
Adverse events — posted to ClinicalTrials.gov
Time frame: From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase).
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Other trials of Sodium Zirconium Cyclosilicate (SZC)
Trials testing the same drug.
NCT06736184 — the Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients
· Phase 4
· not yet recruiting
NCT05347693 — Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study
· Phase 4
· completed
NCT05056727 — A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Particip
· Phase 3
· terminated
NCT04997161 — Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia
· Phase 4
· terminated
Other recruiting trials for Hyperkalemia
Currently open trials in the same condition.
NCT06366230 — Adding Urea to the Final Dialysis Fluid
· Phase 1, PHASE2
· recruiting
NCT06884267 — Hyperkalemia Quality Improvement Program (HK-QIP) Study
· NA
· recruiting
NCT06940414 — Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in Community
· recruiting
NCT05766839 — Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age
· Phase 2
· recruiting
NCT06365684 — Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4
· Phase 4
· recruiting
Other AstraZeneca trials
Trials by the same sponsor.
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NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis
· NA
· not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec
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NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 18 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04847232.