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dc.contributor.authorRoger, SD
dc.contributor.authorLavin, PT
dc.contributor.authorLerma, E
dc.contributor.authorMcCullough, PA
dc.contributor.authorButler, J
dc.contributor.authorSpinowitz, BS
dc.contributor.authorvon Haehling, S
dc.contributor.authorKosiborod, M
dc.contributor.authorZhao, J
dc.contributor.authorFishbane, S
dc.contributor.authorPackham, DK
dc.date.accessioned2020-11-26T22:46:25Z
dc.date.available2020-11-26T22:46:25Z
dc.date.issued2021-01-01
dc.identifierpii: 5728762
dc.identifier.citationRoger, S. D., Lavin, P. T., Lerma, E., McCullough, P. A., Butler, J., Spinowitz, B. S., von Haehling, S., Kosiborod, M., Zhao, J., Fishbane, S. & Packham, D. K. (2021). 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. NEPHROLOGY DIALYSIS TRANSPLANTATION, 36 (1), pp.137-150. https://doi.org/10.1093/ndt/gfz285.
dc.identifier.issn0931-0509
dc.identifier.urihttp://hdl.handle.net/11343/251985
dc.description.abstractBACKGROUND: Sodium zirconium cyclosilicate (SZC; formerly ZS-9) is a selective potassium (K+) binder for the treatment of adults with hyperkalaemia. This post hoc analysis of an open-label, single-arm trial (NCT02163499) compared SZC efficacy and safety >12 months among outpatients with hyperkalaemia and Stages 4 and 5 chronic kidney disease (CKD) versus those with Stages 1-3 CKD. METHODS: Adults with serum K+ ≥5.1 mmol/L (measured by point-of-care i-STAT device) received SZC 10 g three times daily for 24-72 h until normokalaemia (i-STAT K+ 3.5-5.0 mmol/L) was achieved [correction phase (CP)], followed by once daily SZC 5 g for ≤12 months [maintenance phase (MP)]. Here, patients were stratified by baseline estimated glomerular filtration rate (eGFR <30 or ≥30 mL/min/1.73 m2). Study endpoints included percent achieving normokalaemia during CP and MP, mean serum K+ and bicarbonate during MP, and adverse events (AEs). RESULTS: Of 751 patients enrolled, 289 (39%), 453 (60%) and 9 (1%) had baseline eGFR values of <30, ≥30 mL/min/1.73 m2 or missing, respectively. During the CP, 82% of patients achieved normokalaemia in both eGFR subgroups within 24 h, and 100 and 95% with baseline eGFR <30 and ≥30 mL/min/1.73 m2, respectively, within 72 h. Corresponding proportions with normokalaemia during the MP were 82 and 90% at Day 365, respectively. Mean serum K+ reduction from baseline during the CP was sustained throughout the MP and serum bicarbonate increased. AEs during the MP were more common in the eGFR <30 ≥30 mL/min/1.73 m2 subgroup. CONCLUSIONS: SZC corrects hyperkalaemia and maintains normokalaemia among outpatients regardless of the CKD stage.
dc.languageEnglish
dc.publisherOXFORD UNIV PRESS
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0
dc.titleLong-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
dc.typeJournal Article
dc.identifier.doi10.1093/ndt/gfz285
melbourne.affiliation.departmentMedicine (RMH)
melbourne.affiliation.facultyMedicine, Dentistry & Health Sciences
melbourne.source.titleNephrology Dialysis Transplantation
melbourne.source.volume36
melbourne.source.issue1
melbourne.source.pages137-150
dc.rights.licenseCC BY-NC
melbourne.elementsid1436553
melbourne.openaccess.pmchttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC7771984
melbourne.contributor.authorPackham, David
dc.identifier.eissn1460-2385
melbourne.accessrightsOpen Access


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