PMID- 32030422
OWN - NLM
STAT- MEDLINE
DCOM- 20210318
LR  - 20210318
IS  - 1460-2385 (Electronic)
IS  - 0931-0509 (Print)
IS  - 0931-0509 (Linking)
VI  - 36
IP  - 1
DP  - 2021 Jan 1
TI  - 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.
PG  - 137-150
LID - 10.1093/ndt/gfz285 [doi]
AB  - 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.
CI  - (c) The Author(s) 2020. Published by Oxford University Press on behalf of ERA-EDTA.
FAU - Roger, Simon D
AU  - Roger SD
AD  - Renal Research, Gosford, New South Wales, Australia.
FAU - Lavin, Philip T
AU  - Lavin PT
AD  - Boston Biostatistics Research Foundation, Framingham, MA, USA.
FAU - Lerma, Edgar V
AU  - Lerma EV
AD  - University of Illinois at Chicago College of Medicine/Advocate Christ Medical 
      Center, Oak Lawn, IL, USA.
FAU - McCullough, Peter A
AU  - McCullough PA
AD  - Baylor University Medical Center, Dallas, TX, USA.
FAU - Butler, Javed
AU  - Butler J
AD  - Department of Medicine, University of Mississippi, Jackson, MS, USA.
FAU - Spinowitz, Bruce S
AU  - Spinowitz BS
AD  - Division of Nephrology, Department of Medicine, New York Presbyterian Queens, New 
      York, NY, USA.
FAU - von Haehling, Stephan
AU  - von Haehling S
AD  - Department of Cardiology and Pneumology, University of Gottingen Medical Centre, 
      Gottingen, Germany.
FAU - Kosiborod, Mikhail
AU  - Kosiborod M
AD  - Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, 
      Kansas City, MO, USA.
AD  - The George Institute for Global Health, University of New South Wales, Sydney, 
      Australia.
FAU - Zhao, June
AU  - Zhao J
AD  - AstraZeneca, Gaithersburg, MD, USA.
FAU - Fishbane, Steven
AU  - Fishbane S
AD  - Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, USA.
FAU - Packham, David K
AU  - Packham DK
AD  - Melbourne Renal Research Group, Department of Medicine, University of Melbourne, 
      Melbourne, Australia.
LA  - eng
SI  - ClinicalTrials.gov/NCT02163499
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Nephrol Dial Transplant
JT  - Nephrology, dialysis, transplantation : official publication of the European 
      Dialysis and Transplant Association - European Renal Association
JID - 8706402
RN  - 0 (Biomarkers)
RN  - 0 (Silicates)
RN  - D652ZWF066 (sodium zirconium cyclosilicate)
RN  - RWP5GA015D (Potassium)
SB  - IM
MH  - Aged
MH  - Biomarkers/*blood
MH  - Female
MH  - Humans
MH  - Hyperkalemia/blood/*drug therapy/etiology/pathology
MH  - Kidney Failure, Chronic/*complications
MH  - Male
MH  - Middle Aged
MH  - Potassium/*blood
MH  - Prognosis
MH  - Prospective Studies
MH  - Renal Insufficiency, Chronic/*complications
MH  - *Severity of Illness Index
MH  - Silicates/*therapeutic use
PMC - PMC7771984
OTO - NOTNLM
OT  - chronic kidney disease
OT  - estimated glomerular filtration rate
OT  - hyperkalaemia
OT  - potassium
OT  - sodium zirconium cyclosilicate
EDAT- 2020/02/08 06:00
MHDA- 2021/03/19 06:00
PMCR- 2020/02/06
CRDT- 2020/02/08 06:00
PHST- 2020/08/16 00:00 [received]
PHST- 2020/02/08 06:00 [pubmed]
PHST- 2021/03/19 06:00 [medline]
PHST- 2020/02/08 06:00 [entrez]
PHST- 2020/02/06 00:00 [pmc-release]
AID - 5728762 [pii]
AID - gfz285 [pii]
AID - 10.1093/ndt/gfz285 [doi]
PST - ppublish
SO  - Nephrol Dial Transplant. 2021 Jan 1;36(1):137-150. doi: 10.1093/ndt/gfz285.