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NCT02088073 · ClinicalTrials.gov registry record · Phase 3
Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.
A Phase 3 study, sponsored by ZS Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 258
- Enrollment target
NCT02088073: Completed Phase 3 study, sponsored by ZS Pharma.
NCT02088073 is a Phase 3 study that has completed, run by ZS Pharma. The registered enrollment target is 258 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02088073, a Phase 3 study, has completed, sponsored by ZS Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 258 participants
- Enrollment target
Study Summary
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).
Primary Outcome
The least squares means (LSMeans) are dervied from a mixed effects model of serial log transformed S-K values between Days 8 and 29 with patients as a random effect and the following fixed effects terms: MP treatment group; AP baseline eGFR; AP and MP baseline S-K levels, age categories (\<55, 55-64, \>= 65 years); and binary indicators for RAAS inhibitors use, CKD, CHF, and DM. The LSmeans estimate obtained from the above model is back-transformed and presented as the lsmeans of all available S
Interventions
- DRUG Placebo
- DRUG Sodium zirconium cyclosilicate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2014-03-31 |
| Est. Completion | 2015-01-31 |
| Phase | Phase 3 |
What the finished NCT02088073 record still lists
NCT02088073 is an interventional study that assigns participants to a tested intervention. The registered 258 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 (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02088073 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02088073 about?
NCT02088073 is a clinical study titled "Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.". 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 o...
What is the current status of trial NCT02088073?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 258 participants. The study started on 2014-03-31. Estimated completion is 2015-01-31.
What interventions are being tested in trial NCT02088073?
The interventions under investigation include: Placebo (DRUG), Sodium zirconium cyclosilicate (DRUG).
Who is sponsoring clinical trial NCT02088073?
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 NCT02088073's enrollment target sits among peer trials
258 1235th of 2000 higher than 763 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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