Multicenter, Prospective, Randomized, Placebo-Controlled, Double-blind Dose Escalating Study of Safety, Tolerability and Pharmacodynamics of Zirconium Silicate in Chronic Kidney Disease and Moderate Kidney Dysfunction With Mild Hyperkalemia
Phase of Trial: Phase II
Latest Information Update: 24 Feb 2017
At a glance
- Drugs Zirconium silicate (Primary)
- Indications Hyperkalaemia
- Focus Proof of concept; Therapeutic Use
- Sponsors ZS Pharma
- 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.
- 15 Apr 2015 According to ZS Pharma Media Release, the data from this trial was published in Kidney International Feb 2015.
- 15 Apr 2015 Primary endpoint (Potassium levels (Change in serum potassium levels from baseline during the first 48h) has been met, according to ZS Pharma Media Release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History