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Last Updated: March 29, 2024

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.
>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 18
Hyperkalaemia 6
Heart Failure 2
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Condition MeSH

Condition MeSH for sodium zirconium cyclosilicate
Intervention Trials
Hyperkalemia 26
Renal Insufficiency, Chronic 5
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 180
Canada 14
United Kingdom 9
Australia 9
Russian Federation 6
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Trials by US State

Trials by US State for sodium zirconium cyclosilicate
Location Trials
California 13
New York 12
Texas 11
Missouri 11
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 6
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 12
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 19
ZS Pharma, Inc. 3
St George's, University of London 1
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Sponsor Type

Sponsor Type for sodium zirconium cyclosilicate
Sponsor Trials
Industry 23
Other 10
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