Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.
Public ClinicalTrials.gov record NCT02107092. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Open-label Extension to Study ZS-004 [Phase 3 Multicenter, Multi-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-controlled Maintenance Study of Safety Efficacy of ZS (Sodium Zirconium Cycolsilicate) in Hyperkalemia.]
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02107092
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 123 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2014 (Actual)
- Primary completion
- Jul 31, 2015 (Actual)
- Completion
- Aug 31, 2015 (Actual)
- Last update posted
- Aug 15, 2018
2014 – 2015
United States locations
- U.S. sites
- 41
- U.S. states
- 17
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Anniston | Alabama | 36207 | — |
| Not listed | Huntsville | Alabama | 35801 | — |
| Not listed | Scottsboro | Alabama | 35768 | — |
| Not listed | Phoenix | Arizona | 85027 | — |
| Not listed | Tempe | Arizona | 85284 | — |
| Not listed | Hawaiian Gardens | California | 90716 | — |
| Not listed | Los Angeles | California | 90022 | — |
| Not listed | Paramount | California | 90723 | — |
| Not listed | Riverside | California | 92505 | — |
| Not listed | Atlantis | Florida | 33462 | — |
| Not listed | Bradenton | Florida | 34208 | — |
| Not listed | Brandon | Florida | 33511 | — |
| Not listed | Brooksville | Florida | 34601 | — |
| Not listed | DeLand | Florida | 32720 | — |
| Not listed | Edgewater | Florida | 32132 | — |
| Not listed | Miami | Florida | 33015 | — |
| Not listed | Miami | Florida | 33125 | — |
| Not listed | Miami Lakes | Florida | 33014 | — |
| Not listed | Miami Lakes | Florida | 33018 | — |
| Not listed | New Smyrna Beach | Florida | 32168 | — |
| Not listed | Ocala | Florida | 34471 | — |
| Not listed | Summerfield | Florida | 34491 | — |
| Not listed | Tampa | Florida | 33607 | — |
| Not listed | Tampa | Florida | 33614 | — |
| Not listed | Winter Park | Florida | 32789 | — |
| Not listed | Columbus | Georgia | 31901 | — |
| Not listed | Decatur | Georgia | 30030 | — |
| Not listed | Evergreen Park | Illinois | 60805 | — |
| Not listed | Joliet | Illinois | 60435 | — |
| Not listed | Shreveport | Louisiana | 71101 | — |
| Not listed | Auburn | Maine | 04210 | — |
| Not listed | Chesterfield | Michigan | 48047 | — |
| Not listed | Kansas City | Missouri | 64411 | — |
| Not listed | Las Vegas | Nevada | 89115 | — |
| Not listed | Flushing | New York | 11355 | — |
| Not listed | Altoona | Pennsylvania | 16602 | — |
| Not listed | Providence | Rhode Island | 02903 | — |
| Not listed | Orangeburg | South Carolina | 29118 | — |
| Not listed | Sumter | South Carolina | 29150 | — |
| Not listed | Chattanooga | Tennessee | 37408 | — |
| Not listed | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02107092, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 15, 2018 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02107092 live on ClinicalTrials.gov.