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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR SODIUM ZIRCONIUM CYCLOSILICATE

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Clinical Trials for Sodium Zirconium Cyclosilicate

Trial ID Title Status Sponsor Phase Summary
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 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 Active, not recruiting ZS Pharma, Inc. Phase 3 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 Recruiting AstraZeneca Phase 2/Phase 3 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 Not yet recruiting AstraZeneca Phase 3 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Sodium Zirconium Cyclosilicate

Condition Name

Condition Name for Sodium Zirconium Cyclosilicate
Intervention Trials
Hyperkalemia 8
Heart Failure 1
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Condition MeSH

Condition MeSH for Sodium Zirconium Cyclosilicate
Intervention Trials
Hyperkalemia 8
Heart Failure 1
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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 65
Australia 6
Canada 3
Japan 2
South Africa 2
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Trials by US State

Trials by US State for Sodium Zirconium Cyclosilicate
Location Trials
Texas 5
New York 5
Missouri 4
Florida 4
California 4
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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 3 5
Phase 2/Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Sodium Zirconium Cyclosilicate
Clinical Trial Phase Trials
Not yet recruiting 5
Recruiting 2
Active, not recruiting 1
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Clinical Trial Sponsors for Sodium Zirconium Cyclosilicate

Sponsor Name

Sponsor Name for Sodium Zirconium Cyclosilicate
Sponsor Trials
AstraZeneca 7
ZS Pharma, Inc. 2
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Sponsor Type

Sponsor Type for Sodium Zirconium Cyclosilicate
Sponsor Trials
Industry 9
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