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Clinical Trial
. 2019;50(6):473-480.
doi: 10.1159/000504078. Epub 2019 Oct 28.

Efficacy and Safety of Sodium Zirconium Cyclosilicate for Treatment of Hyperkalemia: An 11-Month Open-Label Extension of HARMONIZE

Simon D Roger  1 , Bruce S Spinowitz  2 , Edgar V Lerma  3 , Bhupinder Singh  4   5 , David K Packham  6 , Ayman Al-Shurbaji  7 , Mikhail Kosiborod  8   9
Affiliations
Clinical Trial

Efficacy and Safety of Sodium Zirconium Cyclosilicate for Treatment of Hyperkalemia: An 11-Month Open-Label Extension of HARMONIZE

Simon D Roger et al. Am J Nephrol. 2019.

Abstract

Background: Sodium zirconium cyclosilicate (SZC; formerly ZS-9) is a selective potassium (K+) binder for treatment of hyperkalemia. An open-label extension (OLE) of the -HARMONIZE study evaluated efficacy and safety of SZC for ≤11 months.

Methods: Patients from HARMONIZE with point-of-care device i-STAT K+ 3.5-6.2 mmol/L received once-daily SZC 5-10 g for ≤337 days. End points included achievement of mean serum K+ ≤5.1 mmol/L (primary) or ≤5.5 mmol/L (secondary).

Results: Of 123 patients who entered the extension (mean serum K+ 4.8 mmol/L), 79 (64.2%) completed the study. The median daily dose of SZC was 10 g (range 2.5-15 g). The primary end point was achieved by 88.3% of patients, and 100% achieved the secondary end point. SZC was well tolerated with no new safety concerns.

Conclusion: In the HARMONIZE OLE, most patients maintained mean serum K+ within the normokalemic range for ≤11 months during ongoing SZC treatment.

Keywords: Extension; HARMONIZE; Hyperkalemia; Sodium zirconium cyclosilicate.

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Conflict of interest statement

S.D.R. has received travel fees for investigator meetings and honoraria for serving on advisory boards for AstraZeneca, Vifor Pharma, and ZS Pharma. B.S.S. has received grant support and has served as a consultant for AstraZeneca and ZS Pharma. E.V.L. is a subinvestigator with Research by Design and has received grant support from ZS Pharma. B.S. is a former employee of AstraZeneca, PLC. D.K.P. has received travel fees for investigator meetings and honoraria for serving on advisory boards for AstraZeneca and ZS Pharma. A.A-S. is an employee of AstraZeneca. M.K. has served as a consultant and advisory board member to ZS Pharma and AstraZeneca, was an investigator for clinical trials sponsored by ZS Pharma, and has received research grant support from ­AstraZeneca.

Figures

Fig. 1
Fig. 1
Proportion of patients in the intent-to-treat population with mean serum K+ (a) ≤5.1 mmol/L and (b) ≤5.5 mmol/L with SZC by study visit and overall (days 8–337) in the maintenance phase. Error bars represent 95% CIs. Gray bar represents the proportion of patients across all visits in the maintenance phase. n, the number of patients meeting serum K+ threshold; N, the total number of evaluable patients; Min and Max, minimum and maximum serum K+ values, respectively, in mmol/L. K+, potassium.
See this image and copyright information in PMC

References

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