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

Phase 3 Completed 270 enrolled AstraZeneca

RandomizedParallel-groupDouble-blindTreatment

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 24 or 48 hours of initial ZS therapy (10g TID).

Timeline

Start: 2021-05-06
Primary completion: 2022-09-15
Completion: 2022-09-15

Outcome

Met primary endpoint

paper During the RTP, SZC 5 g and 10 g reduced mean sK+ versus placebo in a dose-dependent manner (each P < 0.001); PMID 39112102 ↗

Publications

Liang X, Lu W, Yu X, Cheng H, He Q, Peng Q, Ni Z, Long G, Wang L, Chen W, Li R, Zhao J, Zhang Y, Lisovskaja V, Tang Z. HARMONIZE Asia: A Phase III Randomized Study to Investigate the Efficacy and Safety of Sodium Zirconium Cyclosilicate in Patients with Hyperkalemia in China. Clin Ther. 2024 Sep;46(9):702-710. doi: 10.1016/j.clinthera.2024.07.004. Epub 2024 Aug 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sodium Zirconium Cyclosilicate	Other / unclassified	5 g	Oral
Subject	Sodium Zirconium Cyclosilicate	Other / unclassified	10 g	Oral

Indications

No indication recorded.