Trial Outcomes & Findings for Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes) (NCT NCT04847232)

Last Updated: 2025-06-18

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

2690 participants

Primary outcome timeframe

From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)

Results posted on

2025-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	SZC (Active) 5 g SZC QD to 15 g SZC QD	Placebo SZC Placebo
Overall Study STARTED	1349	1341
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1349	1341

Reasons for withdrawal

Reasons for withdrawal
Measure	SZC (Active) 5 g SZC QD to 15 g SZC QD	Placebo SZC Placebo
Overall Study Death	123	115
Overall Study Lost to Follow-up	3	10
Overall Study Withdrawal by Subject	73	101
Overall Study Subcategories under "Other" not reported.	1150	1115

Baseline Characteristics

Full analysis set; participants with a non-missing value.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SZC (Active) n=1349 Participants 5 g SZC QD to 15 g SZC QD	Placebo n=1341 Participants SZC Placebo	Total n=2690 Participants Total of all reporting groups
Age, Continuous	55.8 Years STANDARD_DEVIATION 13.3 • n=1349 Participants	56.3 Years STANDARD_DEVIATION 13.6 • n=1341 Participants	56.1 Years STANDARD_DEVIATION 13.4 • n=2690 Participants
Age, Customized 18 yr ≤ Age < 51 yr	442 Participants n=1349 Participants	441 Participants n=1341 Participants	883 Participants n=2690 Participants
Age, Customized 51 yr ≤ Age < 65 yr	526 Participants n=1349 Participants	509 Participants n=1341 Participants	1035 Participants n=2690 Participants
Age, Customized 65 yr ≤ Age < 85 yr	373 Participants n=1349 Participants	378 Participants n=1341 Participants	751 Participants n=2690 Participants
Age, Customized Age ≥ 85 yr	8 Participants n=1349 Participants	13 Participants n=1341 Participants	21 Participants n=2690 Participants
Sex: Female, Male Female	498 Participants n=1349 Participants	517 Participants n=1341 Participants	1015 Participants n=2690 Participants
Sex: Female, Male Male	851 Participants n=1349 Participants	824 Participants n=1341 Participants	1675 Participants n=2690 Participants
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	49 Participants n=1349 Participants	52 Participants n=1341 Participants	101 Participants n=2690 Participants
Race/Ethnicity, Customized ASIAN	392 Participants n=1349 Participants	389 Participants n=1341 Participants	781 Participants n=2690 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	121 Participants n=1349 Participants	130 Participants n=1341 Participants	251 Participants n=2690 Participants
Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	3 Participants n=1349 Participants	2 Participants n=1341 Participants	5 Participants n=2690 Participants
Race/Ethnicity, Customized WHITE	688 Participants n=1349 Participants	672 Participants n=1341 Participants	1360 Participants n=2690 Participants
Race/Ethnicity, Customized OTHER	75 Participants n=1349 Participants	86 Participants n=1341 Participants	161 Participants n=2690 Participants
Race/Ethnicity, Customized NOT REPORTED	21 Participants n=1349 Participants	10 Participants n=1341 Participants	31 Participants n=2690 Participants
spKt/V	1.48 Dimensionless STANDARD_DEVIATION 0.39 • n=1007 Participants • Full analysis set; participants with a non-missing value.	1.51 Dimensionless STANDARD_DEVIATION 0.47 • n=994 Participants • Full analysis set; participants with a non-missing value.	1.49 Dimensionless STANDARD_DEVIATION 0.43 • n=2001 Participants • Full analysis set; participants with a non-missing value.
Dialysis vintage	6.01 Years STANDARD_DEVIATION 5.41 • n=1349 Participants • Full analysis set; participants with a non-missing value.	5.82 Years STANDARD_DEVIATION 5.20 • n=1337 Participants • Full analysis set; participants with a non-missing value.	5.92 Years STANDARD_DEVIATION 5.31 • n=2686 Participants • Full analysis set; participants with a non-missing value.

PRIMARY outcome

Timeframe: From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)

Population: Full analysis set.

Outcome measures

Outcome measures
Measure	SZC (Active) n=1349 Participants 5 g SZC QD to 15 g SZC QD	Placebo n=1341 Participants SZC Placebo
Incidence of the Composite of Cardiac Event Outcomes	119 Participants	119 Participants

SECONDARY outcome

Timeframe: Randomization to 12-Month Visit

Population: Full analysis set. Only subjects with non-missing S-K value at the 12 month visit included in the analysis.

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.

Outcome measures

Outcome measures
Measure	SZC (Active) n=669 Participants 5 g SZC QD to 15 g SZC QD	Placebo n=624 Participants SZC Placebo
Normokalemia at 12 Months Post-randomization	495 Participants with event	293 Participants with event

SECONDARY outcome

Timeframe: From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)

Population: Full analysis set.

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.

Outcome measures

Outcome measures
Measure	SZC (Active) n=1349 Participants 5 g SZC QD to 15 g SZC QD	Placebo n=1341 Participants SZC Placebo
Incidence of the Composite of Arrhythmia Related Events	74 Participants	65 Participants

Adverse Events

SZC (Active)

Serious events: 521 serious events

Other events: 558 other events

Deaths: 120 deaths

Placebo

Serious events: 503 serious events

Other events: 616 other events

Deaths: 113 deaths

Serious adverse events

Other adverse events

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	SZC (Active) n=1348 participants at risk 5 g SZC QD to 15 g SZC QD	Placebo n=1338 participants at risk SZC Placebo
Gastrointestinal disorders Nausea	3.2% 43/1348 • Number of events 51 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	4.4% 59/1338 • Number of events 66 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Gastrointestinal disorders Vomiting	3.3% 44/1348 • Number of events 49 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	4.0% 54/1338 • Number of events 69 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
General disorders Pyrexia	3.7% 50/1348 • Number of events 59 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	3.4% 45/1338 • Number of events 62 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Infections and infestations Covid-19	10.8% 145/1348 • Number of events 153 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	9.1% 122/1338 • Number of events 126 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Blood and lymphatic system disorders Anaemia	4.7% 64/1348 • Number of events 85 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	3.3% 44/1338 • Number of events 55 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Infections and infestations Pneumonia	3.7% 50/1348 • Number of events 55 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	2.2% 30/1338 • Number of events 33 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Infections and infestations Upper respiratory tract infection	2.9% 39/1348 • Number of events 56 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	3.9% 52/1338 • Number of events 59 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Metabolism and nutrition disorders Hyperkalaemia	9.3% 125/1348 • Number of events 188 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	20.9% 280/1338 • Number of events 480 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Musculoskeletal and connective tissue disorders Arthralgia	3.6% 49/1348 • Number of events 59 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	4.0% 54/1338 • Number of events 62 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Musculoskeletal and connective tissue disorders Back pain	3.2% 43/1348 • Number of events 50 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	1.9% 25/1338 • Number of events 31 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Nervous system disorders Headache	3.6% 48/1348 • Number of events 63 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	3.9% 52/1338 • Number of events 71 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Respiratory, thoracic and mediastinal disorders Cough	3.5% 47/1348 • Number of events 52 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	3.1% 41/1338 • Number of events 52 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Vascular disorders Dialysis hypotension	4.1% 55/1348 • Number of events 170 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	4.4% 59/1338 • Number of events 239 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Vascular disorders Hypertension	5.9% 80/1348 • Number of events 180 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	6.1% 82/1338 • Number of events 171 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Gastrointestinal disorders Constipation	5.6% 76/1348 • Number of events 94 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	4.3% 57/1338 • Number of events 74 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Gastrointestinal disorders Diarrhoea	7.3% 98/1348 • Number of events 122 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)	7.0% 93/1338 • Number of events 117 • From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)