Evidence map›Paper›PMID 31201218›Full record

Trial reportJournal of the American Society of Nephrology : JASN2019

A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study of Sodium Zirconium Cyclosilicate for Reducing the Incidence of Predialysis Hyperkalemia.

Steven Fishbane, Martin Ford, Masafumi Fukagawa, Kieran McCafferty, Anjay Rastogi, Bruce Spinowitz, Konstantin Staroselskiy, Konstantin Vishnevskiy, Vera Lisovskaja, Ayman Al-Shurbaji and 2 more

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

Trial report in Journal of the American Society of Nephrology : JASN, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03303521 (A Phase 3b, Multicenter, Prospective, Randomized, Double Blind, Placebocontrolled Study to Reduce Incidence of Pre-dialysis Hyperkalemia With Sodium Zirconium Cyclosilicate), which is not on this map. Cited by 79 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 5 pooled it
12.7field-weighted citation impact, top 1% 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.

NCT03303521 phase3completednot on this map

A Phase 3b, Multicenter, Prospective, Randomized, Double Blind, Placebocontrolled Study to Reduce Incidence of Pre-dialysis Hyperkalemia With Sodium Zirconium Cyclosilicate (DIALIZE)

TypeinterventionalSponsorAstraZenecaRan2017 to 2018Enrolled196ConditionsHyperkalemiaArmsPlacebo, Sodium Zirconium Cyclosilicate (ZS)
3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 5 syntheses or guidelines pooled it, 143 citations in OpenAlex.

  1. Pooled it
  2. 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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19 more citing papers are in PubMed but not listed here.

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

12 authors at 10 institutions in 5 countries.

Steven FishbaneDepartment of Medicine, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York; Sfishbane@northwell.edu.
Martin FordDepartment of Renal Medicine, King's College Hospital NHS Trust, London, United Kingdom.
Masafumi FukagawaDivision of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Japan.
Kieran McCaffertyDepartment of Nephrology, Barts Health NHS Trust, London, United Kingdom.
Anjay RastogiDepartment of Medicine, David Geffen School of Medicine, Los Angeles, California.
Bruce SpinowitzDepartment of Medicine, New York-Presbyterian Queens, Queens, New York.
Konstantin StaroselskiyDepartment #2, B. Braun Avitum Russland Clinics, St. Petersburg, Russia.
Konstantin VishnevskiyPropedeutics of Internal Diseases Chair, First Pavlov State Medical University of St. Petersburg, St. Petersburg, Russia.
Vera LisovskajaBiometrics and Information and.
Ayman Al-ShurbajiGlobal Medicines Development, AstraZeneca, Gothenburg, Sweden.
Nicolas GuzmanGlobal Medicines Development, AstraZeneca, Gaithersburg, Maryland; and.
Sunil BhandariDepartment of Renal and Transplant Medicine, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom.
AstraZeneca (Sweden) · SEAstraZeneca (United States) · USBarts Health NHS Trust · GBFirst Pavlov State Medical University of St. Petersburg · RUHofstra University · USKing's College Hospital · GBNew York Hospital Queens · USTokai University · JPUniversity of California, Los Angeles · USUniversity of Hull · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with ESRD have minimal renal potassium excretion and, despite hemodialysis, often have persistent predialysis hyperkalemia. The DIALIZE study (NCT03303521) evaluated sodium zirconium cyclosilicate (SZC) in the management of hyperkalemia in hemodialysis patients.

methodsIn the DIALIZE study, a double-blind, placebo-controlled, phase 3b multicenter study, we randomized adults with ESRD who were managed by three-times weekly hemodialysis and had predialysis hyperkalemia to receive placebo or SZC 5 g once daily on non-dialysis days, and titrated towards maintaining normokalemia over 4 weeks, in 5 g increments to a maximum of 15 g. The primary efficacy outcome was proportion of patients during the 4-week stable-dose evaluation period who maintained predialysis serum potassium of 4.0-5.0 mmol/L during at least three of four hemodialysis treatments after the long interdialytic interval and did not require urgent rescue therapy to reduce serum potassium.

resultsIn total, 196 patients (mean [standard deviation (SD)] age =58.1 [13.7] years old) were randomized to sodium zirconium cyclosilicate or placebo. Of 97 patients receiving sodium zirconium cyclosilicate, 41.2% met the primary end point and were deemed treatment responders compared with 1.0% of 99 patients receiving placebo (

conclusionsSodium zirconium cyclosilicate is an effective and well-tolerated treatment for predialysis hyperkalemia in patients with ESRD undergoing adequate hemodialysis.

Indexed as

AdolescentAdultAgedAged, 80 and overDouble-Blind MethodFemaleHumansHyperkalemiaIon Exchange ResinsKidney Failure, ChronicMaleMiddle AgedPotassiumRenal DialysisSilicatesYoung AdultIon Exchange ResinsPotassiumSilicatessodium zirconium cyclosilicateclinical trialend-stage renal diseasehemodialysis

Identifiers

PMID31201218
PMCPMC6727265
OpenAlexW2949981799

What OpenQuestion holds

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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.