Evidence map›Paper›PMID 33098526›Full record

Trial reportClinical and experimental nephrology2021

A phase 3 multicenter open-label maintenance study to investigate the long-term safety of sodium zirconium cyclosilicate in Japanese subjects with hyperkalemia.

Naoki Kashihara, Yoshimitsu Yamasaki, Takeshi Osonoi, Hiromasa Harada, Yugo Shibagaki, June Zhao, Hyosung Kim, Toshitaka Yajima, Nobuaki Sarai

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

Trial report in Clinical and experimental nephrology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03172702 (A Phase 3 Multicenter Open-label Maintenance Study to Investigate the Long-term Safety of ZS), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.3field-weighted citation impact, top 16% 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.

NCT03172702 phase3completednot on this map

A Phase 3 Multicenter Open-label Maintenance Study to Investigate the Long-term Safety of ZS (Sodium Zirconium Cyclosilicate) in Japanese Subjects With Hyperkalemia

TypeinterventionalSponsorAstraZenecaRan2017 to 2019Enrolled150ConditionsHyperkalemiaArmsZirconium Cyclosilicate
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 17 citations in OpenAlex.

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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

9 authors at 7 institutions in 3 countries.

Naoki KashiharaDepartment of Nephrology and Hypertension, Kawasaki Medical School, Okayama, Japan.
Yoshimitsu YamasakiAMC Nishi-Umeda Clinic, Osaka, Japan.
Takeshi OsonoiDepartment of Internal Medicine, Nakakinen Clinic, Ibaraki, Japan.
Hiromasa HaradaDepartments of Internal Medicine, Yao Tokushukai General Hospital, Osaka, Japan.
Yugo ShibagakiDivision of Nephrology and Hypertension, St. Marianna University School of Medicine Hospital, Kanagawa, Japan.
June ZhaoCVRM Late-Stage Development, AstraZeneca Gaithersburg, Gaithersburg, USA.
Hyosung KimResearch and Development, AstraZeneca K.K, 1-8-3, Marunouchi, Chiyoda-ku, Tokyo, 100-0005, Japan.
Toshitaka YajimaResearch and Development, AstraZeneca K.K, 1-8-3, Marunouchi, Chiyoda-ku, Tokyo, 100-0005, Japan.
Nobuaki SaraiResearch and Development, AstraZeneca K.K, 1-8-3, Marunouchi, Chiyoda-ku, Tokyo, 100-0005, Japan. nobuaki.sarai@astrazeneca.com.ORCID http://orcid.org/0000-0002-7525-6102
AstraZeneca (Japan) · JPAstraZeneca (United States) · USKawasaki Medical School · JPMito Saiseikai General Hospital · JPOsaka Nishi Clinic · JPSt. Marianna University School of Medicine · JPYao Tokushukai General Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHyperkalemia is associated with many chronic diseases and renin-angiotensin-aldosterone system inhibitor therapy. Sodium zirconium cyclosilicate (SZC), an oral, highly selective cation-exchanger, is approved for the treatment of hyperkalemia.

methodsThis phase 3, multicenter, open-label, single-arm, flexible-dose study assessed the safety and efficacy of SZC in Japanese patients with hyperkalemia during a correction phase of up to 3 days and long-term (1 year) maintenance phase (NCT03172702).

resultsOverall, 150 patients received treatment during both study phases; the study population was generally representative of hyperkalemic Japanese patients in clinical practice. Most patients (78.7%) had three doses of SZC during the correction phase. All but one patient received SZC for ≤ 48 h before transitioning to the maintenance phase. In the maintenance phase, mean (standard deviation; SD) exposure to the study drug was 319.4 (98.1) days and mean (SD) dose was 7.38 (2.85) g/day. Adverse events (AEs) were reported in 131 patients (87.3%); most were mild. The most common treatment-related AEs as evaluated by investigators were constipation (6.7%), peripheral edema (4.0%), and hypertension (2.7%). In the correction phase, 78.7% of patients were normokalemic at 24 h and 98.7% within 48 h; ≥ 65.5% maintained normokalemia throughout the maintenance phase.

conclusionAfter a year of exposure, SZC treatment was well tolerated by Japanese patients and potassium levels were well controlled.

Indexed as

AdultAgedAged, 80 and overFemaleHumansHyperkalemiaMaleMiddle AgedPotassiumSilicatesPotassiumSilicatessodium zirconium cyclosilicateHyperkalemiaJapaneseLong-term safety studySodium zirconium cyclosilicate

Identifiers

PMID33098526
PMCPMC7880936
OpenAlexW3094259877

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.