ZS Ph2/3 Dose-response Study in Japan

Summary

To assess efficacy of 5 g three times daily (TID) and 10 g TID ZS versus placebo in Japanese patients with hyperkalemia (serum potassium \[S-K\] ≥ 5.1 mmol/L and ≤ 6.5 mmol/L).

Timeline

Start

2017-06-14

Primary completion

2018-02-23

Completion

2018-02-23

Outcome

Met primary endpoint

registry analysis (superiority test); ZS 10 g TID vs Placebo TID; p <0.0001; Treatment difference in slopes -0.00496 (95% CI -0.00571 to -0.00420); Mixed Models Analysis NCT03127644 ↗

registry analysis (superiority test); ZS 5 g TID vs Placebo TID; p <0.001; Treatment difference in slopes -0.00261 (95% CI -0.00337 to -0.00185); Mixed Models Analysis NCT03127644 ↗

Publications

• Kashihara N, Nishio T, Osonoi T, Saka Y, Imasawa T, Ohtake T, Mizuno H, Shibagaki Y, Kim H, Yajima T, Sarai N. Correction of serum potassium with sodium zirconium cyclosilicate in Japanese patients with hyperkalemia: a randomized, dose-response, phase 2/3 study. Clin Exp Nephrol. 2020 Dec;24(12):1144-1153. doi: 10.1007/s10157-020-01937-1. Epub 2020 Aug 10.

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.