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NCT01866709 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy of Sodium Polystyrene Sulfonate in Hyperkalemia
A Phase 4 study, sponsored by ZS Pharma.
- Terminated
- Registry status
- Phase 4
- Development phase
- 32
- Enrollment target
NCT01866709: Clinical Trial Phase 4 study, sponsored by ZS Pharma.
NCT01866709 is a Phase 4 study that was terminated before completion, run by ZS Pharma. The registered enrollment target is 32 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01866709, a Phase 4 study, was terminated before completion, sponsored by ZS Pharma.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 32 participants
- Enrollment target
Study Summary
It is hypothesized that SPS is more effective than placebo control (alternative hypothesis) in lowering i-STAT potassium levels in subjects with i-STAT potassium levels between 5.0 - 6.5 mmol/l versus no difference between SPS and placebo control (null hypothesis).
Primary Outcome
To perform a controlled evaluation of the safety and efficacy of 15g of SPS administered 3 times daily for 48 hours (6 doses) in patients with hyperkalemia (serum potassium levels between 5.0 - 6.5 mmol/l) at baseline.
Interventions
- DRUG Sodium polystyrene sulfonate
- DRUG Silicified microcrystalline cellulose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2013-05 |
| Est. Completion | 2013-08 |
| Phase | Phase 4 |
Why NCT01866709 stopped before completion
NCT01866709 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Sodium polystyrene sulfonate is the first listed.
NCT01866709 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01866709 about?
NCT01866709 is a clinical study titled "Safety and Efficacy of Sodium Polystyrene Sulfonate in Hyperkalemia". It is hypothesized that SPS is more effective than placebo control (alternative hypothesis) in lowering i-STAT potassium levels in subjects with i-STAT potassium levels between 5.0 - 6.5 mmol/l versus no difference between SPS and placebo control (null hypothesis).
What is the current status of trial NCT01866709?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2013-05. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01866709?
The interventions under investigation include: Sodium polystyrene sulfonate (DRUG), Silicified microcrystalline cellulose (DRUG).
Who is sponsoring clinical trial NCT01866709?
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 NCT01866709's enrollment target sits among peer trials
32 1534th of 2000 higher than 457 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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