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.
Proportion of Subjects With Mean S-K Between 3.5 and 5.5 mmol/L, Inclusive Months 3 to 12Secondary· 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
Group
Value
95% CI
Proportion
0.985
0.972 – 0.993
Mean S-K Levels Months 3 to 12, Months 6 to 9, and Months 9 to 12.Secondary· 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.
Acute Phase Baseline
Group
Value
95% CI
Mean S-K Levels Months 3 to 12,6 to 9, and 9 to 12
5.59
± 0.425
Extended Dosing Days 85 to 365/End of Study
Group
Value
95% CI
Mean S-K Levels Months 3 to 12,6 to 9, and 9 to 12
4.66
± 0.379
Extended Dosing Days 211 to 267
Group
Value
95% CI
Mean S-K Levels Months 3 to 12,6 to 9, and 9 to 12
4.68
± 0.404
Extended Dosing Days 295 to 365
Group
Value
95% CI
Mean S-K Levels Months 3 to 12,6 to 9, and 9 to 12
4.62
± 0.401
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 PhasePrimary· 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
Group
Value
95% CI
Percentage
77.9
74.8 – 80.9
Percentage of Participants With Mean S-K Values ≤ 5.1 mmol/L During Extended Dosing Phase Days 85 to 365Primary· Study Days 85 to 365
Percentage of subjects with mean S-K values ≤ 5.1 mmol/L during Extended Dosing Phase - ITT Population
Group
Value
95% CI
Percentage
88.4
85.7 – 90.8
Adverse events — posted to ClinicalTrials.gov
Time frame: One year.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The Open-Label Maintenance Study contains an Acute Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a long-term Maintenance Phase.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06578078 — A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients
· Phase 3
· recruiting
NCT06578533 — Keeping RAASi Treatment With Optimal Potassium Control
· Phase 3
· recruiting
NCT04983979 — The ORTIZ Study: Optimising RASi Therapy With SZC
· Phase 2
· terminated
NCT04788641 — Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in He
· Phase 1
· completed
NCT04217590 — Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects
· Phase 3
· completed
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
NCT02107092 — Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.
· Phase 3
· completed
NCT02088073 — Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.
· Phase 3
· completed
NCT01737697 — Safety & Efficacy of Zirconium Silicate in Mild to Moderate Hyperkalemia
· Phase 3
· completed
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: 27 June 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/NCT02163499.