Evidence map›Paper›PMID 31658466›Full record

Trial reportAmerican journal of nephrology2019

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

Simon D Roger, Bruce S Spinowitz, Edgar V Lerma, Bhupinder Singh, David K Packham, Ayman Al-Shurbaji, Mikhail Kosiborod

Abstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in American journal of nephrology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Guideline
  2. Guideline
  3. A European Renal Association (ERA) synopsis for nephrology practice of the 2023 European Society of Hypertension (ESH) Guidelines for the Management of Arterial Hypertension.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2024
    Guideline
  4. Pooled it
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. Article
  10. Article
  11. Observational
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
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  18. Review
  19. Review
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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

7 authors.

Simon D RogerRenal Research, Gosford, New South Wales, Australia, sdroger@bigpond.net.au.
Bruce S SpinowitzDivision of Nephrology, Department of Medicine, NewYork-Presbyterian Queens, New York, New York, USA.
Edgar V LermaSection of Nephrology, Advocate Christ Medical Center, University of Illinois at Chicago, Oak Lawn, Illinois, USA.
Bhupinder SinghZS Pharma, Inc., Part of AstraZeneca, San Mateo, California, USA.
David K PackhamMelbourne Renal Research Group and Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.
Ayman Al-ShurbajiAstraZeneca, Gothenburg, Sweden.
Mikhail KosiborodDepartment of Cardiology, Saint Luke's Mid America Heart Institute and Department of Medicine, University of Missouri-Kansas City, Kansas City, Missouri, USA.

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 treatment of hyperkalemia. An open-label extension (OLE) of the -HARMONIZE study evaluated efficacy and safety of SZC for ≤11 months.

methodsPatients 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).

resultsOf 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.

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

Indexed as

AgedDose-Response Relationship, DrugFemaleHumansHyperkalemiaIon Exchange ResinsMaleMiddle AgedPotassiumProspective StudiesRenin-Angiotensin SystemSilicatesTreatment OutcomeIon Exchange ResinsPotassiumSilicatessodium zirconium cyclosilicateExtensionHARMONIZEHyperkalemiaSodium zirconium cyclosilicate

Identifiers

PMID31658466
PMCPMC6947980

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.