Evidence map›Paper›PMID 32030422›Full record

Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2021

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.

Simon D Roger, Philip T Lavin, Edgar V Lerma, Peter A McCullough, Javed Butler, Bruce S Spinowitz, Stephan von Haehling, Mikhail Kosiborod, June Zhao, Steven Fishbane and 1 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02163499 (Multicenter, Multi-Dose, Open-Label Maintenance of Long-Term Safety and Efficacy of Sodium Zirconium Cyclosilicate), which is not on this map. Cited by 31 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 2 pooled it
4.4field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02163499 phase3completednot on this map

Multicenter, Multi-Dose, Open-Label Maintenance of Long-Term Safety and Efficacy of Sodium Zirconium Cyclosilicate (ZS) in Hyperkalemia

TypeinterventionalSponsorZS Pharma, Inc.Ran2014 to 2016Enrolled751ConditionsHyperkalemiaArmsSodium Zirconium Cyclosilicate
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 2 syntheses or guidelines pooled it, 62 citations in OpenAlex.

  1. Therapeutic update on oral potassium exchange resin use in chronic kidney disease patients: a systematic review of randomized controlled clinical trials.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2023
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  20. In pursuit of balance: renin-angiotensin-aldosterone system inhibitors and hyperkalaemia treatment.European heart journal supplements : journal of the European Society of Cardiology · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 11 institutions in 3 countries.

Simon D RogerRenal Research, Gosford, New South Wales, Australia.
Philip T LavinBoston Biostatistics Research Foundation, Framingham, MA, USA.
Edgar V LermaUniversity of Illinois at Chicago College of Medicine/Advocate Christ Medical Center, Oak Lawn, IL, USA.
Peter A McCulloughBaylor University Medical Center, Dallas, TX, USA.
Javed ButlerDepartment of Medicine, University of Mississippi, Jackson, MS, USA.
Bruce S SpinowitzDivision of Nephrology, Department of Medicine, New York Presbyterian Queens, New York, NY, USA.
Stephan von HaehlingDepartment of Cardiology and Pneumology, University of Göttingen Medical Centre, Göttingen, Germany.
Mikhail KosiborodSaint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, USA.
June ZhaoAstraZeneca, Gaithersburg, MD, USA.
Steven FishbaneZucker School of Medicine at Hofstra/Northwell, Great Neck, NY, USA.
David K PackhamMelbourne Renal Research Group, Department of Medicine, University of Melbourne, Melbourne, Australia.
Advocate Christ Medical Center · USAstraZeneca (United States) · USBaylor University Medical Center · USGosford Hospital · AUHofstra University · USNational Foundation for Cancer Research · USNew York Hospital Queens · USUniversity of Göttingen · DEUniversity of Melbourne · AUUniversity of Mississippi · USUNSW Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSodium 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.

methodsAdults 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).

resultsOf 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.

conclusionsSZC corrects hyperkalaemia and maintains normokalaemia among outpatients regardless of the CKD stage.

Indexed as

Severity of Illness IndexAgedBiomarkersFemaleHumansHyperkalemiaKidney Failure, ChronicMaleMiddle AgedPotassiumPrognosisProspective StudiesRenal Insufficiency, ChronicSilicatesBiomarkersPotassiumSilicatessodium zirconium cyclosilicatechronic kidney diseaseestimated glomerular filtration ratehyperkalaemiapotassiumsodium zirconium cyclosilicate

Identifiers

PMID32030422
PMCPMC7771984
OpenAlexW3005302717

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.