NCT02088073 is a Phase 3 clinical trial of Sodium zirconium cyclosilicate in Hyperkalemia, sponsored by ZS Pharma, Inc..

Who is sponsoring NCT02088073?

NCT02088073 is sponsored by ZS Pharma, Inc..

What drugs are being tested in NCT02088073?

Interventions in NCT02088073: Sodium zirconium cyclosilicate, Placebo.

What condition does NCT02088073 study?

NCT02088073 studies Hyperkalemia.

Is NCT02088073 still recruiting?

NCT02088073 is currently completed. Last updated 7 December 2018.

Are results published for NCT02088073?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-12-07 · How we verify

NCT02088073

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.

Completed Phase 3 Results posted Last updated 7 December 2018

What this trial tests

Phase 3 trial testing Sodium zirconium cyclosilicate in Hyperkalemia in 258 participants. Completed in 31 January 2015.

Timeline

31 March 2014

Primary endpoint
31 August 2014

31 January 2015

Quick facts

Lead sponsor	ZS Pharma, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	258
Start date	31 March 2014
Primary completion	31 August 2014
Estimated completion	31 January 2015
Sites	46 locations across South Africa, United States, Australia

Drugs / interventions tested

Sodium zirconium cyclosilicate — full drug profile →
Placebo

Conditions studied

Hyperkalemia — all drugs for Hyperkalemia →

Sponsor

ZS Pharma, Inc. — full company profile →

Who can join

18 and older, 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.

Mean Serum Potassium Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT Population). Primary · 22 Days; Maintenance Phase Days 8 - 29, inclusive.

The least squares means (LSMeans) are dervied from a mixed effects model of serial log transformed S-K values between Days 8 and 29 with patients as a random effect and the following fixed effects terms: MP treatment group; AP baseline eGFR; AP and MP baseline S-K levels, age categories (\<55, 55-64, \>= 65 years); and binary indicators for RAAS inhibitors use, CKD, CHF, and DM. The LSmeans estimate obtained from the above model is back-transformed and presented as the lsmeans of all available S-K values during the Maintenance phase study Days 8 to 29.

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	5.0603	4.9646 – 5.1578
ZS 5 g Once Daily (Maintenance Phase)	4.7544	4.6350 – 4.8769
ZS 10 g Once Daily (Maintenance Phase)	4.5081	4.4005 – 4.6184
ZS 15 g Once Daily (Maintenance Phase)	4.3742	4.2754 – 4.4753

The Number of Normokalemic Days Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT). Secondary · 22 days; Maintenance Phase Day 8 - 29, inclusive.

The number of normokalemic days during the Maintenance Phase Study Days 8 to 29 is calculated assuming that the interval between assessments is normokalemic only if both the beginning and end assessments for that time interval display normal S-K values (i.e. 3.5 - 5.0 mmol/L)

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	7.4	± 8.0
ZS 5 g Once Daily (Maintenance Phase)	13.4	± 7.57
ZS 10 g Once Daily (Maintenance Phase)	13.9	± 7.91
ZS 15 g Once Daily (Maintenance Phase)	16.8	± 6.99

Mean Change in S-K Levels From Acute Phase Baseline to Maintenance Phase Study Day 2 to Day 29/Exit . Secondary · Acute Phase baseline to Maintenance Phase Study Day 2 to Day 29/Exit, inclusive.

AP Baseline S-K level

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	5.55	± 0.471
ZS 5 g Once Daily (Maintenance Phase)	5.53	± 0.357
ZS 10 g Once Daily (Maintenance Phase)	5.58	± 0.423
ZS 15 g Once Daily (Maintenance Phase)	5.55	± 0.331

MP Study Day 2 Mean Change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	-0.86	± 0.508
ZS 5 g Once Daily (Maintenance Phase)	-1.03	± 0.408
ZS 10 g Once Daily (Maintenance Phase)	-1.25	± 0.471
ZS 15 g Once Daily (Maintenance Phase)	-1.12	± 0.477

MP Study Day 8 Mean Change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	-0.49	± 0.549
ZS 5 g Once Daily (Maintenance Phase)	-0.72	± 0.552
ZS 10 g Once Daily (Maintenance Phase)	-1.09	± 0.629
ZS 15 g Once Daily (Maintenance Phase)	-1.20	± 0.592

MP Study Day 12 Mean Change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	-0.41	± 0.508
ZS 5 g Once Daily (Maintenance Phase)	-0.75	± 0.516
ZS 10 g Once Daily (Maintenance Phase)	-1.11	± 0.663
ZS 15 g Once Daily (Maintenance Phase)	-1.20	± 0.665

MP Study Day 15 Mean Change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	-0.48	± 0.612
ZS 5 g Once Daily (Maintenance Phase)	-0.77	± 0.492
ZS 10 g Once Daily (Maintenance Phase)	-1.11	± 0.652
ZS 15 g Once Daily (Maintenance Phase)	-1.19	± 0.627

MP Study Day 19 Mean Change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	-0.45	± 0.549
ZS 5 g Once Daily (Maintenance Phase)	-0.79	± 0.520
ZS 10 g Once Daily (Maintenance Phase)	-1.04	± 0.581
ZS 15 g Once Daily (Maintenance Phase)	-1.07	± 0.575

MP Study Day 22 Mean Change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	-0.45	± 0.578
ZS 5 g Once Daily (Maintenance Phase)	-0.71	± 0.543
ZS 10 g Once Daily (Maintenance Phase)	-0.93	± 0.653
ZS 15 g Once Daily (Maintenance Phase)	-1.05	± 0.586

MP Study Day 26 Mean Change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	-0.43	± 0.552
ZS 5 g Once Daily (Maintenance Phase)	-0.65	± 0.448
ZS 10 g Once Daily (Maintenance Phase)	-0.87	± 0.697
ZS 15 g Once Daily (Maintenance Phase)	-1.03	± 0.597

Mean Percent Change in S-K Levels From Acute Phase Baseline to Maintenance Phase Study Day 2 to Day 29/Exit, Inclusive . Secondary · Acute Phase baseline to Maintenance Phase Study Day 2 to Day 29/Exit, inclusive.

MP Study Day 2 Percent Change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	-15.11	± 8.154
ZS 5 g Once Daily (Maintenance Phase)	-18.53	± 6.941
ZS 10 g Once Daily (Maintenance Phase)	-22.19	± 7.897
ZS 15 g Once Daily (Maintenance Phase)	-20.04	± 7.959

MP Study Day 8 Percent Change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	-8.45	± 9.492
ZS 5 g Once Daily (Maintenance Phase)	-12.84	± 9.700
ZS 10 g Once Daily (Maintenance Phase)	-19.16	± 10.708
ZS 15 g Once Daily (Maintenance Phase)	-21.29	± 10.135

MP Study Day 12 Percent Change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	-7.22	± 8.967
ZS 5 g Once Daily (Maintenance Phase)	-13.36	± 8.949
ZS 10 g Once Daily (Maintenance Phase)	-19.45	± 11.072
ZS 15 g Once Daily (Maintenance Phase)	-21.22	± 11.368

MP Study Day 15 Percent Change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	-8.28	± 10.739
ZS 5 g Once Daily (Maintenance Phase)	-13.73	± 8.485
ZS 10 g Once Daily (Maintenance Phase)	-19.33	± 10.884
ZS 15 g Once Daily (Maintenance Phase)	-21.19	± 10.675

MP Study Day 19 Percent Change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	-7.87	± 9.554
ZS 5 g Once Daily (Maintenance Phase)	-14.08	± 8.822
ZS 10 g Once Daily (Maintenance Phase)	-18.29	± 9.707
ZS 15 g Once Daily (Maintenance Phase)	-19.10	± 9.957

MP Study Day 22 Percent Change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	-7.74	± 9.992
ZS 5 g Once Daily (Maintenance Phase)	-12.65	± 9.591
ZS 10 g Once Daily (Maintenance Phase)	-16.25	± 11.292
ZS 15 g Once Daily (Maintenance Phase)	-18.65	± 10.034

MP Study Day 26 Percent Change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	-7.54	± 9.386
ZS 5 g Once Daily (Maintenance Phase)	-11.83	± 8.025
ZS 10 g Once Daily (Maintenance Phase)	-15.18	± 11.988
ZS 15 g Once Daily (Maintenance Phase)	-18.28	± 10.271

MP Study Day 29 Percent Change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	-8.23	± 8.586
ZS 5 g Once Daily (Maintenance Phase)	-12.49	± 8.770
ZS 10 g Once Daily (Maintenance Phase)	-18.83	± 11.951
ZS 15 g Once Daily (Maintenance Phase)	-19.80	± 9.503

Mean Change in S-K Levels From Maintenance Phase Baseline to Maintenance Phase Day 2 to Day 29/Exit. Secondary · Maintenance phase baseline to Maintenance Phase Study Day 29/Exit, inclusive.

MP Baseline S-K level

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	4.55	± 0.427
ZS 5 g Once Daily (Maintenance Phase)	4.51	± 0.357
ZS 10 g Once Daily (Maintenance Phase)	4.38	± 0.407
ZS 15 g Once Daily (Maintenance Phase)	4.45	± 0.372

MP Study Day 2 Mean change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	0.13	± 0.411
ZS 5 g Once Daily (Maintenance Phase)	-0.01	± 0.372
ZS 10 g Once Daily (Maintenance Phase)	-0.04	± 0.384
ZS 15 g Once Daily (Maintenance Phase)	-0.02	± 0.400

MP Study Day 8 Mean change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	0.50	± 0.538
ZS 5 g Once Daily (Maintenance Phase)	0.30	± 0.467
ZS 10 g Once Daily (Maintenance Phase)	0.12	± 0.523
ZS 15 g Once Daily (Maintenance Phase)	-0.10	± 0.535

MP Study Day 12 Mean change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	0.60	± 0.580
ZS 5 g Once Daily (Maintenance Phase)	0.26	± 0.541
ZS 10 g Once Daily (Maintenance Phase)	0.10	± 0.594
ZS 15 g Once Daily (Maintenance Phase)	-0.11	± 0.572

MP Study Day 15 Mean change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	0.54	± 0.694
ZS 5 g Once Daily (Maintenance Phase)	0.25	± 0.535
ZS 10 g Once Daily (Maintenance Phase)	0.11	± 0.552
ZS 15 g Once Daily (Maintenance Phase)	-0.10	± 0.546

MP Study Day 19 Mean change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	0.55	± 0.672
ZS 5 g Once Daily (Maintenance Phase)	0.22	± 0.580
ZS 10 g Once Daily (Maintenance Phase)	0.17	± 0.483
ZS 15 g Once Daily (Maintenance Phase)	0.01	± 0.605

MP Study Day 22 Mean change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	0.55	± 0.627
ZS 5 g Once Daily (Maintenance Phase)	0.30	± 0.563
ZS 10 g Once Daily (Maintenance Phase)	0.27	± 0.650
ZS 15 g Once Daily (Maintenance Phase)	0.03	± 0.579

MP Study Day 26 Mean change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	0.55	± 0.623
ZS 5 g Once Daily (Maintenance Phase)	0.34	± 0.565
ZS 10 g Once Daily (Maintenance Phase)	0.33	± 0.673
ZS 15 g Once Daily (Maintenance Phase)	0.05	± 0.594

Mean Percent Change in S-K Levels From Maintenance Phase Baseline to Maintenance Phase Day 2 to Day 29/Exit. Secondary · Maintenance phase baseline to Maintenance Phase Study Day 29/Exit, inclusive.

MP Study Day 2 Percent change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	3.39	± 9.044
ZS 5 g Once Daily (Maintenance Phase)	0.06	± 8.036
ZS 10 g Once Daily (Maintenance Phase)	-0.51	± 8.862
ZS 15 g Once Daily (Maintenance Phase)	-0.20	± 8.984

MP Study Day 8 Percent change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	11.64	± 12.291
ZS 5 g Once Daily (Maintenance Phase)	6.93	± 10.486
ZS 10 g Once Daily (Maintenance Phase)	3.05	± 12.346
ZS 15 g Once Daily (Maintenance Phase)	-1.74	± 12.043

MP Study Day 12 Percent change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	13.70	± 13.072
ZS 5 g Once Daily (Maintenance Phase)	6.38	± 12.287
ZS 10 g Once Daily (Maintenance Phase)	2.85	± 13.595
ZS 15 g Once Daily (Maintenance Phase)	-2.00	± 12.836

MP Study Day 15 Percent change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	12.51	± 15.693
ZS 5 g Once Daily (Maintenance Phase)	5.95	± 12.169
ZS 10 g Once Daily (Maintenance Phase)	2.93	± 12.662
ZS 15 g Once Daily (Maintenance Phase)	-1.89	± 12.118

MP Study Day 19 Percent change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	12.96	± 15.791
ZS 5 g Once Daily (Maintenance Phase)	5.33	± 12.934
ZS 10 g Once Daily (Maintenance Phase)	4.28	± 11.231
ZS 15 g Once Daily (Maintenance Phase)	.095	± 13.697

MP Study Day 22 Percent change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	12.84	± 14.342
ZS 5 g Once Daily (Maintenance Phase)	6.98	± 12.774
ZS 10 g Once Daily (Maintenance Phase)	6.79	± 15.174
ZS 15 g Once Daily (Maintenance Phase)	1.39	± 12.782

MP Study Day 26 Percent change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	13.03	± 14.566
ZS 5 g Once Daily (Maintenance Phase)	7.98	± 12.932
ZS 10 g Once Daily (Maintenance Phase)	8.08	± 15.516
ZS 15 g Once Daily (Maintenance Phase)	1.88	± 16.641

MP Study Day 29 Percent change

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	12.09	± 13.116
ZS 5 g Once Daily (Maintenance Phase)	6.12	± 14.424
ZS 10 g Once Daily (Maintenance Phase)	3.02	± 17.785
ZS 15 g Once Daily (Maintenance Phase)	-1.43	± 13.664

Median Time to Hyperkalemia (S-K ≥ 5.1mmol/L) Secondary · Maintenance Phase baseline to maintenance Phase Study Day 29/Exit.

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	7	6 – 7
ZS 5 g Once Daily (Maintenance Phase)	14	7 – 28
ZS 10 g Once Daily (Maintenance Phase)	NA	NA – NA
ZS 15 g Once Daily (Maintenance Phase)	NA	NA – NA

Mean S-K Intra-subject Standard Deviation Calculated Among Subjects With ≥ 2 Values on or After Maintenance Phase Study Day 8 Secondary · 22 days; Maintenance Phase Day 8 - 29

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	0.06392	0.05804 – 0.06980
ZS 5 g Once Daily (Maintenance Phase)	0.06367	0.05574 – 0.07159
ZS 10 g Once Daily (Maintenance Phase)	0.07708	0.06941 – 0.08474
ZS 15 g Once Daily (Maintenance Phase)	0.06849	0.06126 – 0.07571

Proportion of Subjects Who Remained Normokalemic During Maintenance Phase Secondary · Maintenance Phase Study Days 1, 2, 5, 8, 12, 15, 19, 22, 26, 29, and 35, inclusive.

Baseline

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	0.866
ZS 5 g Once Daily (Maintenance Phase)	0.933
ZS 10 g Once Daily (Maintenance Phase)	0.920
ZS 15 g Once Daily (Maintenance Phase)	0.926

MP Study Day 2

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	0.84
ZS 5 g Once Daily (Maintenance Phase)	0.933
ZS 10 g Once Daily (Maintenance Phase)	0.918
ZS 15 g Once Daily (Maintenance Phase)	0.944

MP Study Day 8

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	0.481
ZS 5 g Once Daily (Maintenance Phase)	0.711
ZS 10 g Once Daily (Maintenance Phase)	0.820
ZS 15 g Once Daily (Maintenance Phase)	0.852

MP Study Day 12

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	0.400
ZS 5 g Once Daily (Maintenance Phase)	0.750
ZS 10 g Once Daily (Maintenance Phase)	0.787
ZS 15 g Once Daily (Maintenance Phase)	0.849

MP Study Day 15

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	0.438
ZS 5 g Once Daily (Maintenance Phase)	0.705
ZS 10 g Once Daily (Maintenance Phase)	0.851
ZS 15 g Once Daily (Maintenance Phase)	0.827

MP Study Day 19

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	0.449
ZS 5 g Once Daily (Maintenance Phase)	0.744
ZS 10 g Once Daily (Maintenance Phase)	0.787
ZS 15 g Once Daily (Maintenance Phase)	0.882

MP Study Day 22

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	0.442
ZS 5 g Once Daily (Maintenance Phase)	0.674
ZS 10 g Once Daily (Maintenance Phase)	0.667
ZS 15 g Once Daily (Maintenance Phase)	0.882

MP Study Day 26

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	0.486
ZS 5 g Once Daily (Maintenance Phase)	0.738
ZS 10 g Once Daily (Maintenance Phase)	0.711
ZS 15 g Once Daily (Maintenance Phase)	0.843

Median Time to Relapse in S-K Values Secondary · Maintenance phase Study Day 1 to Study Day 29/Exit.

Median time to relapse in S-K values (return to original Acute Phase S-K baseline value)

Group	Value	95% CI
Placebo Comparator (Maintenance Phase)	19	12 – 28
ZS 5 g Once Daily (Maintenance Phase)	29	29 – NA
ZS 10 g Once Daily (Maintenance Phase)	NA	NA – NA
ZS 15 g Once Daily (Maintenance Phase)	NA	NA – NA

Exponential Rate of Change in S-K Values During the Acute Phase at 24 Hours and 48 Hours of Study Drug Treatment. Secondary · Acute Phase 24 hours and Acute Phase 48 hours.

24 hours after start of ZS dosing

Group	Value	95% CI
Acute Phase: ZS 10 g TID	-0.00373	± 0.000231

48 hours of start of ZS dosing

Group	Value	95% CI
Acute Phase: ZS 10 g TID	-0.00324	± 0.000130

Mean Change From Baseline in S-K Values (Blood) at All Measured Time Intervals Post Dose Acute Phase. Secondary · All measured time intervals post dose during the Acute Phase.

Acute phase baseline

Group	Value	95% CI
Acute Phase: ZS 10 g TID	5.55	± 0.449

1 hour after start of ZS dosing Mean change

Group	Value	95% CI
Acute Phase: ZS 10 g TID	-0.23	± 0.435

2 hours after start of ZS dosing Mean change

Group	Value	95% CI
Acute Phase: ZS 10 g TID	-0.41	± 0.440

4 hours after start of ZS dosing Mean change

Group	Value	95% CI
Acute Phase: ZS 10 g TID	-0.51	± 0.405

24 hours after start of ZS dosing Mean change

Group	Value	95% CI
Acute Phase: ZS 10 g TID	-0.68	± 0.448

1 hour after 1st dose Study Day 2 Mean change

Group	Value	95% CI
Acute Phase: ZS 10 g TID	-0.75	± 0.444

48 hours after start of ZS dosing Mean change

Group	Value	95% CI
Acute Phase: ZS 10 g TID	-1.05	± 0.510

Adverse events — posted to ClinicalTrials.gov

Time frame: All adverse events were collected beginning with the first administration of study drug and through end of study treatment follow up visit. End of treatment study follow up visit was 7 days +/- 1 day after last dose of investigational product.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ZS 10 g TID (Acute Phase)

Serious: 0/258 (0%)

Deaths: —

Placebo Comparator (Maintenance Phase)

Serious: 0/85 (0%)

Deaths: —

ZS 5 g Once Daily (Maintenance Phase)

Serious: 5/45 (11%)

Deaths: —

ZS 10 g Once Daily (Maintenance Phase)

Serious: 2/51 (4%)

Deaths: —

ZS 15 g Once Daily (Maintenance Phase)

Serious: 3/56 (5%)

Deaths: —

Serious adverse events (9 terms)

Reaction	System	ZS 10 g TID (Acute Phase)	Placebo Comparator (Mainte…	ZS 5 g Once Daily (Mainten…	ZS 10 g Once Daily (Mainte…	ZS 15 g Once Daily (Mainte…
Cardiac failure congestive	Cardiac disorders	—	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—
Generalized edema	General disorders	—	—	—	—	—
Hepatotoxicity	Hepatobiliary disorders	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—
Confusional state	Psychiatric disorders	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—

Other adverse events (29 terms — click to expand)

Reaction	System	ZS 10 g TID (Acute Phase)	Placebo Comparator (Mainte…	ZS 5 g Once Daily (Mainten…	ZS 10 g Once Daily (Mainte…	ZS 15 g Once Daily (Mainte…
Edema	General disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Upper respiratory infection	Infections and infestations	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—
Generalised Oedema	General disorders	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Renal failure	Renal and urinary disorders	—	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Dysponea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—
Urinary tract infection bacterial	Infections and infestations	—	—	—	—	—
Electrocardiogram QT prolonged	Investigations	—	—	—	—	—
Gout	Metabolism and nutrition disorders	—	—	—	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Dysuria	Renal and urinary disorders	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—

Most-reported serious reactions: Cardiac failure congestive, Myocardial infarction, Small intestinal obstruction, Generalized edema, Hepatotoxicity, Cellulitis, Pneumonia, Confusional state.

Data from ClinicalTrials.gov NCT02088073 adverse events section.

Sponsor's own description

It is hypothesized that ZS is more effective than placebo control (alternative hypothesis) in maintaining mean double-blind randomized maintenance phase (DBRMP) Day 8-29 serum potassium levels (3.5 - 5.0 mmol/l, inclusive) among hyperkalemic subjects in whom normokalemia was established during the open-label acute phase versus no difference between each ZS dose (highest to lowest) versus placebo control (null hypothesis).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Effect of sodium zirconium cyclosilicate on potassium lowering for 28 days among outpatients with hyperkalemia: the HARMONIZE randomized clinical trial.
Kosiborod M, Rasmussen HS, Lavin P, Qunibi WY, et al · · 2014 · cited 293× · PMID 25402495 · DOI 10.1001/jama.2014.15688
Emergency Potassium Normalization Treatment Including Sodium Zirconium Cyclosilicate: A Phase II, Randomized, Double-blind, Placebo-controlled Study (ENERGIZE).
Peacock WF, Rafique Z, Vishnevskiy K, Michelson E, et al · · 2020 · cited 57× · PMID 32149451 · DOI 10.1111/acem.13954
Efficacy and Safety of Sodium Zirconium Cyclosilicate for Treatment of Hyperkalemia: An 11-Month Open-Label Extension of HARMONIZE.
Roger SD, Spinowitz BS, Lerma EV, Singh B, et al · · 2019 · cited 55× · PMID 31658466 · DOI 10.1159/000504078
Potassium binders for chronic hyperkalaemia in people with chronic kidney disease.
Natale P, Palmer SC, Ruospo M, Saglimbene VM, et al · · 2020 · cited 30× · PMID 32588430 · DOI 10.1002/14651858.cd013165.pub2
Sodium zirconium cyclosilicate increases serum bicarbonate concentrations among patients with hyperkalaemia: exploratory analyses from three randomized, multi-dose, placebo-controlled trials.
Roger SD, Spinowitz BS, Lerma EV, Fishbane S, et al · · 2021 · cited 18× · PMID 32588050 · DOI 10.1093/ndt/gfaa158
Efficacy and safety of sodium zirconium cyclosilicate in patients with baseline serum potassium level ≥ 5.5 mmol/L: pooled analysis from two phase 3 trials.
Amin AN, Menoyo J, Singh B, Kim CS. · · 2019 · cited 17× · PMID 31791288 · DOI 10.1186/s12882-019-1611-8
Cost effectiveness of sodium zirconium cyclosilicate for the treatment of hyperkalaemia in patients with CKD in Norway and Sweden.
Kim K, Fagerström J, Chen G, Lagunova Z, et al · · 2022 · cited 13× · PMID 35953778 · DOI 10.1186/s12882-022-02903-7
Hyperkalemia management: a multidisciplinary expert panel's perspective on the role of new potassium binders.
Fonseca C, Garagarza C, Silva G, Caires G, et al · · 2025 · cited 3× · PMID 39604607 · DOI 10.1007/s10741-024-10461-3

Verify or expand the search:

Other trials of Sodium zirconium cyclosilicate

Trials testing the same drug.

NCT06365684 — Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4 · Phase 4 · recruiting
NCT04789239 — OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure · Phase 2 · active not recruiting
NCT04727528 — Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis · Phase 3 · terminated
NCT04676646 — Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Recei · Phase 4 · completed
NCT04585542 — Comparison of Potassium Binders in the ER · 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 ZS Pharma, Inc. trials

Trials by the same sponsor.

NCT02607085 — REal World EVidence for TrEAtment of HyperkaLemia in Emergency Department: Multicenter, Prospective, Observational Study · completed
NCT02609841 — POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study · completed
NCT02163499 — Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months · Phase 3 · completed
NCT02107092 — Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia. · Phase 3 · completed
NCT01737697 — Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02088073 (US National Library of Medicine, public domain)
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 ZS Pharma, Inc.
Last refreshed: 7 December 2018

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/NCT02088073.

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NCT02088073

Quick facts

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Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (9 terms)

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Related trials

Other trials of Sodium zirconium cyclosilicate

Other recruiting trials for Hyperkalemia

Other ZS Pharma, Inc. trials

Verify against primary sources