CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 258 enrolled
Drug / intervention
Sodium zirconium cyclosilicate +1 moredrug
Likely dose
Not stated in 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/NCT02088073
NCT02088073Phase 3Completed
CompareCT.gov

Multicenter, Multi-phase, Multi-dose, Prospective, Double-blind, Placebo-controlled, Maintenance Study of Safety and Efficacy of ZS (Microporous, Fractionated, Protonated Zirconium Silicate) in Hyperkalemia.

ZS Pharma, Inc.·interventional·Posted Mar 14, 2014·Updated Dec 7, 2018

In Brief

A Phase 3 clinical trial evaluating Sodium zirconium cyclosilicate and Placebo for Hyperkalemia. Completed, enrolled 258 participants across 46 sites in 3 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperkalemia
CountriesAustralia, South Africa, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 14, 2014
Enrollment StartMar 31, 2014
Primary CompletionAug 31, 2014
Study CompletionJan 31, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.3 years ago

Interventions

Sodium zirconium cyclosilicatedrug

Sodium zirconium cyclosilicate

Placebodrug

Randomized to mimic doses of experimental drug administered once daily with breakfast for 28 days (maintenance phase)