A Phase 3 Study to Investigate the long term safety and efficacy of ZS

• Research type

  Research Study

• Full title

  A Phase 3 Multicenter, Multi-dose, Open-label Maintenance Study to Investigate the Long-term Safety and Efficacy of ZS (Sodium Zirconium Cyclosilicate), an Oral Sorbent, in Subjects with Hyperkalemia.

• IRAS ID

  168232

• Contact name

  Jonathan Barratt

• Contact email

  jonathan.barratt@uhl-tr.nhs.uk

• Sponsor organisation

  ZS Pharma Inc.

• Eudract number

  2014-004555-31

• Clinicaltrials.gov Identifier

  NCT02163499

• Duration of Study in the UK

  1 years, 9 months, 0 days

• Research summary

  This study is being performed to see how safe the study drug (ZS) is during long-term treatment and how it affects the amount of potassium in the blood of patients with high levels of potassium. In the Acute Phase the study drug (dose 10g) is taken orally three times a day, just before meals for 3 days. In the Maintenance Phase it is taken once daily for up to 12 months.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  15/NW/0028

• Date of REC Opinion

  22 Jan 2015

• REC opinion

  Further Information Favourable Opinion