At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Sodium Zirconium Cyclosilicate (ZS) 10g, Sodium Zirconium Cyclosilicate (ZS) 5g, and 1 other intervention for Hyperkalemia. Completed, enrolled 267 participants across 45 sites in 4 countries.
Detailed 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).
Study Details
Timeline
Interventions
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)
Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.
Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.
Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.