CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 751 enrolled
Drug / intervention
Sodium Zirconium Cyclosilicatedrug
Likely dose
Sodium Zirconium Cyclosilicate 10 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02163499
NCT02163499Phase 3Completed
CompareCT.gov

Multicenter, Multi-Dose, Open-Label Maintenance of Long-Term Safety and Efficacy of Sodium Zirconium Cyclosilicate (ZS) in Hyperkalemia

ZS Pharma, Inc.·interventional·Posted Jun 13, 2014·Updated Jun 27, 2018

In Brief

A Phase 3 clinical trial evaluating Sodium Zirconium Cyclosilicate for Hyperkalemia. Completed, enrolled 751 participants across 50 sites in 7 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperkalemia
CountriesAustralia, Germany, Netherlands, Romania, South Africa, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 13, 2014
Enrollment StartJun 30, 2014
Primary CompletionNov 30, 2016
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.1 years ago

Interventions

Sodium Zirconium Cyclosilicatedrug

Acute Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) for 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD). Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) based on i-STAT potassium measurements up to 12 months.