Phase I Study of the Pharmacodynamics and Safety of Sodium Zirconium Cyclosilicate in Healthy Chinese Adults

Abstract

Sodium zirconium cyclosilicate (SZC) is an effective potassium binder for patients with hyperkalemia. This single-center, open-label, phase I study (NCT03283267) characterized the pharmacodynamics and safety of SZC in Chinese individuals. Twenty-two healthy Chinese adults (mean age, 33.5 years) randomized 1:1 received daily oral SZC 5 or 10 g for 4 days, following 4 days on a low-sodium, high-potassium diet (continued throughout the study). End points were mean change from baseline in 24-hour urinary potassium (primary) and sodium excretion,and serum potassium concentration.Urinary potassium excretion significantly decreased with SZC 5 g (mean change [mmol], -13.0; P < .001) and 10 g (-15.4; P < .001). Although urinary sodium excretion decreased significantly with SZC 5 g (-11.5; P = .030), there was no significant change with SZC 10 g (-5.1; P = .299). Serum potassium concentrations decreased significantly with SZC 5 g (-0.14; P = .031) and 10 g (-0.20; P = .002). All treatment-emergent adverse events were mild, and none were considered causally related to SZC. Over 4 days, the pharmacodynamics and safety of SZC were consistent in healthy Chinese adults with global studies and patients of Japanese ethnicity.

Evaluation of safety, effectiveness and treatment patterns of sodium zirconium cyclosilicate in management of hyperkalaemia in China: a real-world study protocol

“…The study also reported mild treatment-emergent AEs and none related to SZC 29. Similar results were reported in a study on Chinese adult healthy participants 30. A phase II ZS002 clinical study carried out on patients with CKD and HK demonstrated significant reduction in sK levels in patients administered with 3 and 10 g of SZC in a dose-dependent manner as compared with placebo.…”

Effect of sodium zirconium cyclosilicate in combination with insulin and glucose infusion on hyperkalemia treatment

“…Sodium zirconium cyclosilicate (SZC) stands as the groundbreaking potassium binder and the first to gain listing in China [10][11]. It accurately captures potassium ions and effectively controls blood potassium levels rapidly and persistently with good overall tolerability [12].…”