Trial · NCT02163499

Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months

NCT02163499, Phase 3, Completed, ZS Pharma, Inc.; results first posted 2018-06-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months. Trials, record NCT02163499. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02163499

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Trial

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

Title: Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months
NCT number: NCT02163499
Status: Completed
Phases: Phase 3
Enrollment: 751 participants, actual
Lead sponsor: ZS Pharma, Inc.
Conditions: Hyperkalemia
Interventions: Sodium Zirconium Cyclosilicate
First posted: 2014-06-13
Last updated: 2018-06-27
Results first posted: 2018-06-27

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Percent of Participants With Restoration of Normal Serum Potassium (S-K) Values (3.5 to 5.0 mmol/L, Inclusive) at the End of the Acute Phase	72 Hours	Percentage of subjects with S-K values between 3.5 and 5.0 mmol/L, inclusive at the end of the Acute Phase - ITT Population
Primary	Percentage of Participants With Mean S-K Values ≤ 5.1 mmol/L During Extended Dosing Phase Days 85 to 365	Study Days 85 to 365	Percentage of subjects with mean S-K values ≤ 5.1 mmol/L during Extended Dosing Phase - ITT Population
Secondary	Proportion of Subjects With Mean S-K Between 3.5 and 5.5 mmol/L, Inclusive Months 3 to 12	Study Days 85 to 365	Proportion of Subjects with mean S-K between 3.5 and 5.5 mmol/L during Extended Dosing Phase - ITT Population
Secondary	Mean S-K Levels Months 3 to 12, Months 6 to 9, and Months 9 to 12.	Study days 85 to 365	Mean S-K levels months 3 to 12(EP Days 85, 113, 141, 176, 211, 239, 267, 295, 330, 365 and EOS),months 6 to 9, and months 9 to 12.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Proportion of Subjects With Mean S-K Between 3.5 and 5.5 mmol/L, Inclusive Months 3 to 12	Study Days 85 to 365	Extended phase ITT population	Proportion of participants	NUMBER
SECONDARY	Mean S-K Levels Months 3 to 12, Months 6 to 9, and Months 9 to 12.	Study days 85 to 365	Extended phase ITT population	mmol/L	MEAN
PRIMARY	Percent of Participants With Restoration of Normal Serum Potassium (S-K) Values (3.5 to 5.0 mmol/L, Inclusive) at the End of the Acute Phase	72 Hours	The Intent To Treat populations for the Acute Phase (AP-ITT) included subjects who received at least one dose of ZS with at least one S-K assessment after administration of Acute Phase ZS.~Efficacy: Separate analyses were performed for the Acute and Extended Dosing Phases.	Percentage of participants	NUMBER
PRIMARY	Percentage of Participants With Mean S-K Values ≤ 5.1 mmol/L During Extended Dosing Phase Days 85 to 365	Study Days 85 to 365	The Extended Phase Intent To Treat populations (EP-ITT) included subjects who received at least one dose of ZS in the EP and have at least one S-K assessment after administration of Extended Phase ZS.~Efficacy: Separate analyses were performed for the Acute and Extended Dosing Phases.	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group7

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

Outcome	Group	Category	Value	Spread	Units
Proportion of Subjects With Mean S-K Between 3.5 and 5.5 mmol/L, Inclusive Months 3 to 12	Proportion		0.985	95% Confidence Interval 0.972 to 0.993	Proportion of participants
Mean S-K Levels Months 3 to 12, Months 6 to 9, and Months 9 to 12.	Mean S-K Levels Months 3 to 12,6 to 9, and 9 to 12	Acute Phase Baseline	5.59	Standard Deviation 0.425	mmol/L
Mean S-K Levels Months 3 to 12, Months 6 to 9, and Months 9 to 12.	Mean S-K Levels Months 3 to 12,6 to 9, and 9 to 12	Extended Dosing Days 85 to 365/End of Study	4.66	Standard Deviation 0.379	mmol/L
Mean S-K Levels Months 3 to 12, Months 6 to 9, and Months 9 to 12.	Mean S-K Levels Months 3 to 12,6 to 9, and 9 to 12	Extended Dosing Days 211 to 267	4.68	Standard Deviation 0.404	mmol/L
Mean S-K Levels Months 3 to 12, Months 6 to 9, and Months 9 to 12.	Mean S-K Levels Months 3 to 12,6 to 9, and 9 to 12	Extended Dosing Days 295 to 365	4.62	Standard Deviation 0.401	mmol/L
Percent of Participants With Restoration of Normal Serum Potassium (S-K) Values (3.5 to 5.0 mmol/L, Inclusive) at the End of the Acute Phase	Percentage		77.9	95% Confidence Interval 74.8 to 80.9	Percentage of participants
Percentage of Participants With Mean S-K Values ≤ 5.1 mmol/L During Extended Dosing Phase Days 85 to 365	Percentage		88.4	95% Confidence Interval 85.7 to 90.8	Percentage of participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Acute Phase: ZS 10 g TID	STARTED	Subject Disposition	751
Acute Phase: ZS 10 g TID	COMPLETED	Subject Disposition	746
Acute Phase: ZS 10 g TID	NOT COMPLETED	Subject Disposition	5
Extended Dosing Phase: ZS	STARTED	Subject Disposition	746
Extended Dosing Phase: ZS	COMPLETED	Subject Disposition	466
Extended Dosing Phase: ZS	NOT COMPLETED	Subject Disposition	280

Source ClinicalTrials.gov

Adverse events286

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
other	Anaemia	Blood and lymphatic system disorders	Acute Phase: ZS	0	751
other	Anaemia	Blood and lymphatic system disorders	Extended Dosing Phase: ZS	42	746
other	Hypertension	Vascular disorders	Acute Phase: ZS	1	751
other	Hypertension	Vascular disorders	Extended Dosing Phase: ZS	78	746
other	Oedema peripheral	General disorders	Acute Phase: ZS	1	751
other	Oedema peripheral	General disorders	Extended Dosing Phase: ZS	72	746
other	Nausea	Gastrointestinal disorders	Acute Phase: ZS	4	751
other	Nausea	Gastrointestinal disorders	Extended Dosing Phase: ZS	56	746
other	Constipation	Gastrointestinal disorders	Acute Phase: ZS	2	751
other	Constipation	Gastrointestinal disorders	Extended Dosing Phase: ZS	46	746

1 to 10 of 286Source ClinicalTrials.gov

See all 286 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Acute Phase: ZS	0	751
Total, all-cause mortality	Extended Dosing Phase: ZS	8	746
Total, other adverse events	Acute Phase: ZS	11	751
Total, other adverse events	Extended Dosing Phase: ZS	386	746
Total, serious adverse events	Acute Phase: ZS	1	751
Total, serious adverse events	Extended Dosing Phase: ZS	161	746

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32030422	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 comparisons2

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

Comparison	Source
Acute Phase: ZS vs Extended Dosing Phase: ZS: deaths from any cause	Trial comparisons
Acute Phase: ZS vs Extended Dosing Phase: ZS: 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/NCT02163499

GET https://conductscience.org/api/trials/v1/NCT02163499/events?page=2

API reference For AI assistants