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NCT02107092 · ClinicalTrials.gov registry record · Phase 3
Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.
A Phase 3 study, sponsored by ZS Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 123
- Enrollment target
NCT02107092: Completed Phase 3 study, sponsored by ZS Pharma.
NCT02107092 is a Phase 3 study that has completed, run by ZS Pharma. The registered enrollment target is 123 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02107092, a Phase 3 study, has completed, sponsored by ZS Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 123 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The proportions of subjects with average serum potassium (S-K) values ≤ 5.1 mmol/L during Extended Dosing Study Days 8 to 337, inclusive
Interventions
- DRUG Sodium Zirconium Cyclosilicate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2014-05-31 |
| Est. Completion | 2015-08-31 |
| Phase | Phase 3 |
What the finished NCT02107092 record still lists
NCT02107092 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which Sodium Zirconium Cyclosilicate is the first listed.
NCT02107092 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02107092 about?
NCT02107092 is a clinical study titled "Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.". 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...
What is the current status of trial NCT02107092?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 123 participants. The study started on 2014-05-31. Estimated completion is 2015-08-31.
What interventions are being tested in trial NCT02107092?
The interventions under investigation include: Sodium Zirconium Cyclosilicate (DRUG).
Who is sponsoring clinical trial NCT02107092?
This trial is sponsored by ZS Pharma, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02107092's enrollment target sits among peer trials
123 1615th of 2000 higher than 384 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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