The trial is designed to further add to the clinical experience to date by showing the safety and tolerability of ZS-9 and its ability to restore and maintain normal serum potassium levels in patients with hyperkalemia over at least one year of dosing.
ZS intends to submit a new drug application (NDA) to the US Food and Drug Administration (FDA) and a marketing authorization application (MAA) with the European Medicines Agency (EMA) in the first half of 2015.
About 500 patients with hyperkalemia (potassium levels >5 mEq/L) at up to 100 clinical sites in the US, Europe, Australia and South Africa, will be enrolled in the global, multicenter, multi-dose Phase III trial, which will investigate the long-term safety and efficacy of ZS-9 in these patients.
Patients will be given a 10 gram dose of ZS-9 administered three times daily for 24 to 72 hours during the Induction Phase of the trial followed by 12 months of a 5 gram dose of ZS-9 administered once-daily with titration if needed in the Maintenance Phase of the trial.
The trial’s primary endpoint is safety and tolerability, while secondary endpoint is the proportion of patients who can maintain normokalemia over pre-specified time periods over the 12-month period.
The company said that the ZS-9 clinical program is designed to investigate the treatment of acute and chronic hyperkalemia, regardless of underlying cause.
Image: ZS Pharma will enrol about 500 hyperkalemia patients in ZS005 its Phase III trial of ZS-9. Photo: courtesy of foto76