Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months

Phase 3 Completed 751 enrolled ZS Pharma, Inc.

NaSingle-groupOpen-labelSupportive care

Summary

The Open-Label Maintenance Study contains an Acute Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a long-term Maintenance Phase.

Timeline

Start: 2014-06-30
Primary completion: 2016-11-30
Completion: 2016-11-30

Publications

Roger SD, Lavin PT, Lerma EV, McCullough PA, Butler J, Spinowitz BS, von Haehling S, Kosiborod M, Zhao J, Fishbane S, Packham DK. Long-term safety and efficacy of sodium zirconium cyclosilicate for hyperkalaemia in patients with mild/moderate versus severe/end-stage chronic kidney disease: comparative results from an open-label, Phase 3 study. Nephrol Dial Transplant. 2021 Jan 1;36(1):137-150. doi: 10.1093/ndt/gfz285.

Drugs

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

Indications

No indication recorded.