At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 103 enrolled
Drug / intervention
Sodium Zirconium Cyclosilicate (ZS) 5g +2 moredrug
Likely dose
Sodium Zirconium Cyclosilicate (ZS) 5gfrom 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.
A Phase 2/3 Multicenter, Dose-response Study to Assess Efficacy and Safety of ZS (Sodium Zirconium Cyclosilicate), in Japanese Patients With Hyperkalemia
In Brief
A Phase 3 clinical trial evaluating Sodium Zirconium Cyclosilicate (ZS) 5g, Sodium Zirconium Cyclosilicate (ZS) 10g, and 1 other intervention for Hyperkalemia. Completed, enrolled 103 participants across 25 sites.
Detailed Summary
To assess efficacy of 5 g three times daily (TID) and 10 g TID ZS versus placebo in Japanese patients with hyperkalemia (serum potassium \[S-K\] ≥ 5.1 mmol/L and ≤ 6.5 mmol/L).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperkalemia
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartJun 2017
Primary CompletionFeb 2018
TodayJul 2026
First PostedApr 25, 2017
Enrollment StartJun 14, 2017
Primary CompletionFeb 23, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.2 years ago
Interventions
Sodium Zirconium Cyclosilicate (ZS) 5gdrug
Suspension administered 5g orally three times daily for 48 hours.
Sodium Zirconium Cyclosilicate (ZS) 10gdrug
Suspension administered 10g orally three times daily for 48 hours.
Placebodrug
Placebo suspension administered orally placebo three times daily for 48 hours.