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.
Phase of Trial: Phase III
Latest Information Update: 18 May 2018
At a glance
- Drugs Zirconium silicate (Primary)
- Indications Hyperkalaemia
- Focus Registrational; Therapeutic Use
- Acronyms HARMONIZE
- Sponsors ZS Pharma
- 18 May 2018 According to an AstraZaneca media release, based on the data of these studies (238578, 240595,240601, 242292 and 242482), the US Food and Drug Administration (FDA) has approved LOKELMATM (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalemia in adults.
- 24 Feb 2017 According to an AstraZaneca media release, the Committee for Medicinal Products for Human Use (CHMP) of the EMA has issued a positive opinion recommending the approval of ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia. The recommendation was based on data from this and three other phase III trials.
- 16 Nov 2016 Results of post-hoc pooled analysis (n=153) of data from two phase III ZS-9 trials (ZS-003 and HARMONIZE) assessing the effects of ZS-9 in heart failure patients with hyperkalemia on maximal doses of RAASi, submaximal RAASi, or no RAASi at baseline, presented at the 89th Annual Scientific Sessions of the American Heart Association.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History