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.

ABSTRACT:

Background

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.

SUBMITTER: Roger SD 

PROVIDER: S-EPMC7771984 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature