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
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