NCT02875834

A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia

A Phase 3 Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of ZS, in Patients With Hyperkalemia-HARMONIZE Global

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having achieved normokalemia following two days of initial ZS therapy (10g TID).

Conditions

• Hyperkalemia

Interventions

Type	Name	Description
DRUG	Sodium Zirconium Cyclosilicate (ZS) 10g	Suspension administered 10g orally three times per day, in the first 48-hour of the study for all patients (48-hour open label initial phase)
DRUG	Sodium Zirconium Cyclosilicate (ZS) 5g	Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.
DRUG	Sodium Zirconium Cyclosilicate (ZS) 10g	Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.
DRUG	Placebo	Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.

Timeline

• Start date: 2017-03-03
• Primary completion: 2018-02-14
• Completion: 2018-02-14
• First posted: 2016-08-23
• Last updated: 2020-08-19
• Results posted: 2020-08-19

Locations

45 sites across 4 countries: Japan, Russia, South Korea, Taiwan