Trial · NCT04847232

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

NCT04847232, Phase 3, Terminated, AstraZeneca; results first posted 2025-06-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes). Trials, record NCT04847232. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04847232

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
NCT number: NCT04847232
Status: Terminated
Phases: Phase 3
Enrollment: 2,690 participants, actual
Lead sponsor: AstraZeneca
Conditions: Hyperkalemia
Interventions: Sodium Zirconium Cyclosilicate (SZC), SZC Placebo
First posted: 2021-04-19
Last updated: 2025-06-18
Other registries' IDs: eudract:2020-005561-14
Results first posted: 2025-06-18
Limitations and caveats: Study was terminated early due to lower-than-expected primary event rate and higher than anticipated drop-out rate. Lower number of evaluable events reduces the precision of the primary analysis considerably.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence of the Composite of Cardiac Event Outcomes	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.
Secondary	Normokalemia at 12 Months Post-randomization	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.
Secondary	Incidence of the Composite of Arrhythmia Related Events	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of the Composite of Cardiac Event Outcomes	From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	Full analysis set.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Normokalemia at 12 Months Post-randomization	Randomization to 12-Month Visit	Full analysis set. Only subjects with non-missing S-K value at the 12 month visit included in the analysis.	Participants with event	NUMBER
SECONDARY	Incidence of the Composite of Arrhythmia Related Events	From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	Full analysis set.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Incidence of the Composite of Cardiac Event Outcomes	SZC (Active)	119	Participants
Incidence of the Composite of Cardiac Event Outcomes	Placebo	119	Participants
Normokalemia at 12 Months Post-randomization	SZC (Active)	495	Participants with event
Normokalemia at 12 Months Post-randomization	Placebo	293	Participants with event
Incidence of the Composite of Arrhythmia Related Events	SZC (Active)	74	Participants
Incidence of the Composite of Arrhythmia Related Events	Placebo	65	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SZC (Active)	1,349
Overall Study	STARTED	Placebo	1,341
Overall Study	COMPLETED	SZC (Active)	0
Overall Study	COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	SZC (Active)	1,349
Overall Study	NOT COMPLETED	Placebo	1,341

Source ClinicalTrials.gov

Adverse events1,230

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	SZC (Active)	43	1,348	51
other	Nausea	Gastrointestinal disorders	Placebo	59	1,338	66
other	Vomiting	Gastrointestinal disorders	SZC (Active)	44	1,348	49
other	Vomiting	Gastrointestinal disorders	Placebo	54	1,338	69
other	Pyrexia	General disorders	SZC (Active)	50	1,348	59
other	Pyrexia	General disorders	Placebo	45	1,338	62
other	Covid-19	Infections and infestations	SZC (Active)	145	1,348	153
other	Covid-19	Infections and infestations	Placebo	122	1,338	126
other	Anaemia	Blood and lymphatic system disorders	SZC (Active)	64	1,348	85
other	Anaemia	Blood and lymphatic system disorders	Placebo	44	1,338	55

1 to 10 of 1,230Source ClinicalTrials.gov

See all 1,230 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SZC (Active)	120	1,348
Total, all-cause mortality	Placebo	113	1,338
Total, other adverse events	SZC (Active)	558	1,348
Total, other adverse events	Placebo	616	1,338
Total, serious adverse events	SZC (Active)	521	1,348
Total, serious adverse events	Placebo	503	1,338

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
37230521	DERIVED	PubMed
40618849	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
SZC (Active) vs Placebo: Incidence of the Composite of Cardiac Event Outcomes	Trial comparisons
SZC (Active) vs Placebo: Incidence of the Composite of Arrhythmia Related Events	Trial comparisons
SZC (Active) vs Placebo: deaths from any cause	Trial comparisons
SZC (Active) vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04847232

GET https://conductscience.org/api/trials/v1/NCT04847232/events?page=2

API reference For AI assistants