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Last Updated: August 10, 2022

CLINICAL TRIALS PROFILE FOR SODIUM ZIRCONIUM CYCLOSILICATE


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All Clinical Trials for Sodium Zirconium Cyclosilicate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02088073 ↗ Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia. Completed ZS Pharma, Inc. Phase 3 2014-03-31 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).
NCT02107092 ↗ Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia. Completed ZS Pharma, Inc. Phase 3 2014-05-31 Subjects who completed the Double-blind Randomized Maintenance Phase (DBRMP) Study Day 29 visit in ZS-004 (NCT 02088073) and have an i-STAT potassium value that is 3.5 to 6.2 mmol/l inclusive or who discontinued during ZS-004 due to hypo- or hyperkalemia in the DBRMP and have a mean i-STAT potassium value from two consecutive measurements at 0 and 60 minutes on Acute Phase Day 1/Maintenance Phase Day 1 that is 3.5 to 6.2 mmol/l inclusive may have the option to participate in ZS-004E (NCT 021070920). Subjects who discontinued from study ZS-004 due to any other reasons (e.g. adverse events, poor compliance, investigator decision) will not be entered into study ZS-004E. All subjects who continue into the extension study must begin dosing within two (2) days after the last dose of investigational product in ZS-004.
NCT02163499 ↗ Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months Completed ZS Pharma, Inc. Phase 3 2014-06-30 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.
NCT03127644 ↗ ZS Ph2/3 Dose-response Study in Japan Completed AstraZeneca Phase 2/Phase 3 2017-06-14 To assess efficacy of 5 g three times daily (TID) and 10 g TID ZS versus placebo in Japanese patients with hyperkalemia (serum potassium [S-K] ≥ 5.1 mmol/L and ≤ 6.5 mmol/L).
NCT03172702 ↗ Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia Completed AstraZeneca Phase 3 2017-09-04 The Open-Label Maintenance Study contains an Correction Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a 12-month long-term Maintenance Phase.
NCT03283267 ↗ A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS) Completed AstraZeneca Phase 1 2017-10-24 This is a single center, inpatient, open label pharmacodynamic study to determine the effect of 5 g and 10 g doses of Sodium Zirconium Cyclosilicate (ZS) administered once daily (qd) for 4 days on potassium and sodium excretion in healthy Chinese subjects on a standardized, low sodium and high potassium diet.
NCT03303521 ↗ A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients. Completed AstraZeneca Phase 3 2017-12-14 The purpose of this study is to evaluate the efficacy of ZS in the treatment of hyperkalemia in patients on hemodialysis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sodium Zirconium Cyclosilicate

Condition Name

Condition Name for Sodium Zirconium Cyclosilicate
Intervention Trials
Hyperkalemia 17
Hyperkalaemia 6
Chronic Kidney Disease 2
Chronic Kidney Diseases 2
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Condition MeSH

Condition MeSH for Sodium Zirconium Cyclosilicate
Intervention Trials
Hyperkalemia 25
Renal Insufficiency, Chronic 5
Heart Failure 4
Kidney Diseases 4
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Clinical Trial Locations for Sodium Zirconium Cyclosilicate

Trials by Country

Trials by Country for Sodium Zirconium Cyclosilicate
Location Trials
United States 175
Canada 14
Australia 9
United Kingdom 9
Russian Federation 6
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Trials by US State

Trials by US State for Sodium Zirconium Cyclosilicate
Location Trials
New York 12
California 12
Texas 11
Missouri 10
Florida 9
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Clinical Trial Progress for Sodium Zirconium Cyclosilicate

Clinical Trial Phase

Clinical Trial Phase for Sodium Zirconium Cyclosilicate
Clinical Trial Phase Trials
Phase 4 5
Phase 3 13
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Sodium Zirconium Cyclosilicate
Clinical Trial Phase Trials
Recruiting 11
Completed 10
Not yet recruiting 3
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Clinical Trial Sponsors for Sodium Zirconium Cyclosilicate

Sponsor Name

Sponsor Name for Sodium Zirconium Cyclosilicate
Sponsor Trials
AstraZeneca 18
ZS Pharma, Inc. 3
Steno Diabetes Center Copenhagen 1
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Sponsor Type

Sponsor Type for Sodium Zirconium Cyclosilicate
Sponsor Trials
Industry 22
Other 9
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