CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 150 enrolled
Drug / intervention
Zirconium Cyclosilicatedrug
Likely dose
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/NCT03172702
NCT03172702Phase 3Completed
CompareCT.gov

A Phase 3 Multicenter Open-label Maintenance Study to Investigate the Long-term Safety of ZS (Sodium Zirconium Cyclosilicate) in Japanese Subjects With Hyperkalemia

AstraZeneca·interventional·Posted Jun 1, 2017·Updated May 1, 2020

In Brief

A Phase 3 clinical trial evaluating Zirconium Cyclosilicate for Hyperkalemia. Completed, enrolled 150 participants across 42 sites.

Detailed Summary

The Open-Label Maintenance Study contains an Correction Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a 12-month long-term Maintenance Phase.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperkalemia
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 1, 2017
Enrollment StartSep 4, 2017
Primary CompletionJul 6, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.1 years ago

Interventions

Zirconium Cyclosilicatedrug

Correction Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) from 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) (or 2.5 g QD) based on i-STAT potassium measurements up to 12 months.