NCT03303521

A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.

A Phase 3b, Multicenter, Prospective, Randomized, Double Blind, Placebocontrolled Study to Reduce Incidence of Pre-dialysis Hyperkalemia With Sodium Zirconium Cyclosilicate (DIALIZE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of ZS in the treatment of hyperkalemia in patients on hemodialysis.

Conditions

• Hyperkalemia

Interventions

Type	Name	Description
DRUG	Placebo	Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) . Single dose contains from 1 to 3 sachets of Placebo depending on dose level assigned to a patient per non-dialysis days.
DRUG	Sodium Zirconium Cyclosilicate (ZS)	Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) . Single dose contains from 1 to 3 sachets of ZS 5g depending on dose level assigned to a patient per non-dialysis days.

Timeline

• Start date: 2017-12-14
• Primary completion: 2018-11-07
• Completion: 2018-11-07
• First posted: 2017-10-06
• Last updated: 2020-02-20
• Results posted: 2020-02-20

Locations

53 sites across 4 countries: United States, Japan, Russia, United Kingdom

Regulatory

• FDA-regulated drug study