Study identifier:D9480C00001
ClinicalTrials.gov identifier:NCT03528681
EudraCT identifier:N/A
CTIS identifier:N/A
A phase 3 multicenter, prospective, randomized, double-blind, placebo-controlled study to investigate the safety and efficacy of ZS (sodium zirconium cyclosilicate), in patients with hyperkalemia-HARMONIZE Asia
Hyperkalemia
Phase 3
No
Sodium Zirconium Cyclosilicate 5g, Sodium Zirconium Cyclosilicate 10g, Placebo
All
250
Interventional
18 Years - 90 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Sept 2023 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Sodium Zirconium Cyclosilicate 10g Suspension administered 10g orally once daily for 28 days after the open label initial phase. | Drug: Sodium Zirconium Cyclosilicate 10g Suspension administered Sodium Zirconium Cyclosilicate 10g orally once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days. |
Experimental: Sodium Zirconium Cyclosilicate 5g Suspension administered 5g orally once daily for 28 days after the open label initial phase. | Drug: Sodium Zirconium Cyclosilicate 5g Suspension administered Sodium Zirconium Cyclosilicate 5g orally once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days. |
Placebo Comparator: Matching Placebo Suspension administered orally placebo once daily for 28 days after the open label initial phase. | Drug: Placebo Suspension administered orally placebo once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days. |