Multicenter, Two-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-Controlled Study of Safety and Efficacy of Microporous, Fractionated, Protonated Zirconium Silicate in Mild to Moderate Hyperkalemia

Trial Profile

Multicenter, Two-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-Controlled Study of Safety and Efficacy of Microporous, Fractionated, Protonated Zirconium Silicate in Mild to Moderate Hyperkalemia

Completed
Phase of Trial: Phase III

Latest Information Update: 18 May 2018

At a glance

  • Drugs Zirconium silicate (Primary)
  • Indications Hyperkalaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors ZS Pharma
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top