Journal article
Sodium Zirconium Cyclosilicate among Individuals with Hyperkalemia A 12-Month Phase 3 Study
Bruce S Spinowitz, Steven Fishbane, Pablo E Pergola, Simon D Roger, Edgar V Lerma, Javed Butler, Stephan von Haehling, Scott H Adler, June Zhao, Bhupinder Singh, Philip T Lavin, Peter A McCullough, Mikhail Kosiborod, David K Packham
Clinical Journal of the American Society of Nephrology | AMER SOC NEPHROLOGY | Published : 2019
DOI: 10.2215/CJN.12651018
Abstract
BACKGROUND AND OBJECTIVES: Oral sodium zirconium cyclosilicate (formerly ZS-9) binds and removes potassium via the gastrointestinal tract. Sodium zirconium cyclosilicate-associated restoration and maintenance of normokalemia and adverse events were evaluated in a two-part, open label, phase 3 trial. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In the correction phase, adult outpatients with plasma potassium ≥5.1 mmol/L (i-STAT Point-of-Care) received sodium zirconium cyclosilicate 10 g three times daily for 24-72 hours until normokalemic (potassium =3.5-5.0 mmol/L). Qualifying participants entered the ≤12-month maintenance phase and received sodium zirconium cyclosilicate 5 g once daily ti..
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Funding Acknowledgements
Wethank the investigators and participants who participated in this study. Jeff Martin, MS, of Boston Biostatistics Research Foundation, Steven Chang, BS, of Xelay Acumen, and Pharmapace, Inc. provided data analytical support. Henrik Rasmussen, MD, Wajeh Y. Qunibi, MD, and Mohamed A. El-Shahawy, MD, MPH, MHA, provided critical support in the interim analysis for regulatory submission. Blair Jarvis, on behalf of inScience Communications, Springer Healthcare (Philadelphia, PA) and Jessica Deckman, PhD, CMPP, Julian Martins, MA, and Disha Patel, PhD, CMPP, of inScience Communications, Springer Healthcare (Philadelphia, PA), provided editorial support funded by AstraZeneca. MaryBethDeYoung, PhD, of AstraZeneca provided critical review of the manuscript. Authors did not receive compensation for their contribution to this publication. The studywas initiated and performed by ZS Pharma, Inc., a member of the AstraZeneca family of companies. Funding for editorial support was provided by AstraZeneca.