Trial · NCT03528681

A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia.

NCT03528681, Phase 3, Completed, AstraZeneca; results first posted 2025-05-14

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia. Trials, record NCT03528681. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03528681

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Trial

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

Title: A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia.
NCT number: NCT03528681
Status: Completed
Phases: Phase 3
Enrollment: 270 participants, actual
Lead sponsor: AstraZeneca
Conditions: Hyperkalemia
Interventions: Sodium Zirconium Cyclosilicate 5g, Sodium Zirconium Cyclosilicate 10g, Placebo
First posted: 2018-05-18
Last updated: 2025-05-14
Results first posted: 2025-05-14

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	Least Square Mean S-K Level on Days 8-29	Days 8 to 29 (Randomized treatment study phase) used for model-based least squares mean computation	Comparison between placebo and each SZC treatment group (high to low) with regard to the mean S-K level during the randomized treatment phase days 8-29. Mixed-effects models were used to estimate least-squares means.
Secondary	Percentage of Patients Who Achieve Normokalemia	Through open label initial phase	Percentage of patients who achieve normokalemia during the open label initial phase at 24 hours and at the end of the open label phase. End of OLP is defined as Day 2 (24 hours post first dose) or Day 3 (48 hours post first dose) depending on when the subject achieved normokalemia based on the pre-dose i-STAT potassium level. The results in the table below are presented for OLP.
Secondary	Exponential Rate of Change in S-K Levels	Through 24 hours post-dose in the initial phase	Exponential rate of change in S-K levels (blood) during the open-label initial phase 24 hours post-dose. Least Square Mean corresponds to the exponential rate of change i.e. the slope (for time) in terms of log-transformed S-K levels. The results in the table below are presented for OLP.
Secondary	Absolute Change From Baseline in S-K Levels	Through open label initial phase	Absolute change from baseline in S-K levels at all measured time intervals. End of OLP is defined as Day 2 (24 hours post first dose) or Day 3 (48 hours post first dose) depending on when the subject achieved normokalemia based on the pre-dose i-STAT potassium level. The results in the table below are presented for OLP.
Secondary	Percentage Change From Baseline in S-K Levels	Through open label initial phase	Percentage change from baseline in S-K levels at all measured time intervals. End of OLP is defined as Day 2 (24 hours post first dose) or Day 3 (48 hours post first dose) depending on when the subject achieved normokalemia based on the pre-dose i-STAT potassium level. The results in the table below are presented for OLP.
Secondary	Proportion of Patients Who Remain Normokalemic During RTP	Through 28-day randomized treatment study phase day 8-29	Proportion of patients who remain normokalemic (as defined by S-K between 3.5-5.0 mmol/l, inclusive) during RTP (Day 8 to Day 29). The results in the table below are presented for RTP.
Secondary	Proportion of Normokalemic Patients at the End of RTP	The end of 28-day randomized treatment study phase	Proportion of normokalemic patients (as defined by S-K between 3.5-5.0 mmol/l, inclusive). The results in the table below are presented for RTP.
Secondary	Days Patients Remain Normokalemic	Through days 8-29 of the randomized treatment phase.	The number of days patients remain normokalemic during days 8-29 of the randomized treatment study phase. The results in the table below are presented for RTP.
Secondary	Mean Change in S-K Levels	Through 28-day randomized treatment phase.	The mean change in S-K levels evaluated relative to the RTP baseline. The results in the table below are presented for RTP.
Secondary	Mean Percent Change in S-K Levels	Through 28-day randomized treatment phase.	The mean percent change in S-K levels evaluated relative to the RTP baseline. The results in the table below are presented for RTP.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Least Square Mean S-K Level on Days 8-29	Days 8 to 29 (Randomized treatment study phase) used for model-based least squares mean computation	Full analysis set - Randomized Treatment Phase	mmol/L	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Patients Who Achieve Normokalemia	Through open label initial phase	Full analysis set - Open Label Phase	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Exponential Rate of Change in S-K Levels	Through 24 hours post-dose in the initial phase	Full analysis set - Open Label Phase	log(mmol/L)/h	LEAST_SQUARES_MEAN
SECONDARY	Absolute Change From Baseline in S-K Levels	Through open label initial phase	Full analysis set - Open Label Phase	mmol/L	MEAN
SECONDARY	Percentage Change From Baseline in S-K Levels	Through open label initial phase	Full analysis set - Open Label Phase	Percentage	MEAN
SECONDARY	Proportion of Patients Who Remain Normokalemic During RTP	Through 28-day randomized treatment study phase day 8-29	Full analysis set - Randomized Treatment Phase	Average probability	NUMBER
SECONDARY	Proportion of Normokalemic Patients at the End of RTP	The end of 28-day randomized treatment study phase	Full analysis set - Randomized Treatment Phase	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Days Patients Remain Normokalemic	Through days 8-29 of the randomized treatment phase.	Full analysis set - Randomized Treatment Phase	Day	LEAST_SQUARES_MEAN
SECONDARY	Mean Change in S-K Levels	Through 28-day randomized treatment phase.	Full analysis set - Randomized Treatment Phase	mmol/L	MEAN
SECONDARY	Mean Percent Change in S-K Levels	Through 28-day randomized treatment phase.	Full analysis set - Randomized Treatment Phase	Percent change	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group91

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

Outcome	Group	Category	Value	Spread	Units
Least Square Mean S-K Level on Days 8-29	Sodium Zirconium Cyclosilicate (SZC) 5g QD		4.859	95% Confidence Interval 4.709 to 5.014	mmol/L
Least Square Mean S-K Level on Days 8-29	Sodium Zirconium Cyclosilicate (SZC) 10g QD		4.440	95% Confidence Interval 4.304 to 4.580	mmol/L
Least Square Mean S-K Level on Days 8-29	Placebo		5.225	95% Confidence Interval 5.055 to 5.400	mmol/L
Percentage of Patients Who Achieve Normokalemia	Sodium Zirconium Cyclosilicate (SZC) 10g TID	Normokalemic at 24h	180		Participants
Percentage of Patients Who Achieve Normokalemia	Sodium Zirconium Cyclosilicate (SZC) 10g TID	Normokalemic at End of OLP	228		Participants
Exponential Rate of Change in S-K Levels	Sodium Zirconium Cyclosilicate (SZC) 10g TID		-0.0051	Standard Error 0.00027	log(mmol/L)/h
Absolute Change From Baseline in S-K Levels	Sodium Zirconium Cyclosilicate (SZC) 10g TID	OLP - 24 hours	-0.936	Standard Deviation 0.377	mmol/L
Absolute Change From Baseline in S-K Levels	Sodium Zirconium Cyclosilicate (SZC) 10g TID	End of OLP	-1.107	Standard Deviation 0.466	mmol/L
Percentage Change From Baseline in S-K Levels	Sodium Zirconium Cyclosilicate (SZC) 10g TID	OLP - 24 hours	-15.880	Standard Deviation 5.980	Percentage
Percentage Change From Baseline in S-K Levels	Sodium Zirconium Cyclosilicate (SZC) 10g TID	End of OLP	-18.588	Standard Deviation 6.701	Percentage

1 to 10 of 91Source ClinicalTrials.gov

See all 91 results by group

Participant flow24

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

Period	Milestone	Group	Participants
Open-Label Phase	STARTED	Sodium Zirconium Cyclosilicate (SZC) 10g TID	270
Open-Label Phase	STARTED	Sodium Zirconium Cyclosilicate (SZC) 5g QD	0
Open-Label Phase	STARTED	Sodium Zirconium Cyclosilicate (SZC) 10g QD	0
Open-Label Phase	STARTED	Placebo	0
Open-Label Phase	COMPLETED	Sodium Zirconium Cyclosilicate (SZC) 10g TID	256
Open-Label Phase	COMPLETED	Sodium Zirconium Cyclosilicate (SZC) 5g QD	0
Open-Label Phase	COMPLETED	Sodium Zirconium Cyclosilicate (SZC) 10g QD	0
Open-Label Phase	COMPLETED	Placebo	0
Open-Label Phase	NOT COMPLETED	Sodium Zirconium Cyclosilicate (SZC) 10g TID	14
Open-Label Phase	NOT COMPLETED	Sodium Zirconium Cyclosilicate (SZC) 5g QD	0

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events440

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	Sinus arrhythmia	Cardiac disorders	Sodium Zirconium Cyclosilicate (SZC) 10g TID	0	270	0
other	Sinus arrhythmia	Cardiac disorders	Sodium Zirconium Cyclosilicate (SZC) 5g QD	1	100	1
other	Sinus arrhythmia	Cardiac disorders	Sodium Zirconium Cyclosilicate (SZC) 10g QD	0	100	0
other	Sinus arrhythmia	Cardiac disorders	Placebo	0	50	0
other	Dermatitis	Skin and subcutaneous tissue disorders	Sodium Zirconium Cyclosilicate (SZC) 10g TID	1	270	1
other	Dermatitis	Skin and subcutaneous tissue disorders	Sodium Zirconium Cyclosilicate (SZC) 5g QD	0	100	0
other	Dermatitis	Skin and subcutaneous tissue disorders	Sodium Zirconium Cyclosilicate (SZC) 10g QD	0	100	0
other	Dermatitis	Skin and subcutaneous tissue disorders	Placebo	0	50	0
other	Hyperhidrosis	Skin and subcutaneous tissue disorders	Sodium Zirconium Cyclosilicate (SZC) 10g TID	0	270	0
other	Hyperhidrosis	Skin and subcutaneous tissue disorders	Sodium Zirconium Cyclosilicate (SZC) 5g QD	1	100	1

1 to 10 of 440Source ClinicalTrials.gov

See all 440 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sodium Zirconium Cyclosilicate (SZC) 10g TID	0	270
Total, all-cause mortality	Sodium Zirconium Cyclosilicate (SZC) 5g QD	0	100
Total, all-cause mortality	Sodium Zirconium Cyclosilicate (SZC) 10g QD	0	100
Total, all-cause mortality	Placebo	0	50
Total, other adverse events	Sodium Zirconium Cyclosilicate (SZC) 10g TID	38	270
Total, other adverse events	Sodium Zirconium Cyclosilicate (SZC) 5g QD	48	100
Total, other adverse events	Sodium Zirconium Cyclosilicate (SZC) 10g QD	42	100
Total, other adverse events	Placebo	17	50
Total, serious adverse events	Sodium Zirconium Cyclosilicate (SZC) 10g TID	1	270
Total, serious adverse events	Sodium Zirconium Cyclosilicate (SZC) 5g QD	6	100

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39112102	DERIVED

Source 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 comparisons0

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

None in this release.

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.

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