ZS-004

• Research type

  Research Study

• Full title

  A Phase 3 Multicenter, Multi-phase, Multi Dose, Prospective, Randomized, Doubleblind, Placebo-controlled Maintenance Study to Investigate the Safety and Efficacy of ZS (Microporous, Fractionated, Protonated Zirconium Silicate), an Oral Sorbent, in Subjects with Hyperkalemia.

• IRAS ID

  138073

• Contact name

  Jonathan Barratt

• Contact email

  jonathan.barratt@uhl-tr.nhs.uk

• Sponsor organisation

  ZS Pharma Inc

• Eudract number

  2013-003391-13

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study is being done to see how safe the study drug (ZS) is and how it affects the amount of potassium in the blood of patients with high levels of potassium. 4 doses will be tested in this study, in order to identify the best dose to
  use in patients. 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 a day at breakfast time for 28 days. In this phase patients will be randomly assigned to receive one of 3 doses of the study drug or placebo. The patient and the doctor will not know what the patient is receiving (double-blinded).

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  13/EM/0346

• Date of REC Opinion

  6 Nov 2013

• REC opinion

  Further Information Favourable Opinion