Evidence map›Paper›PMID 32493693›Full record

Trial reportJournal of the American Society of Nephrology : JASN2020

Phase 3, Randomized, Double-Blind, Active-Comparator (Darbepoetin Alfa) Study of Oral Roxadustat in CKD Patients with Anemia on Hemodialysis in Japan.

Tadao Akizawa, Manabu Iwasaki, Yusuke Yamaguchi, Yoshikatsu Majikawa, Michael Reusch

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIComparative StudyEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American Society of Nephrology : JASN, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02952092 (A Phase 3, Multi-center, Randomized, 2-arm Parallel, Double-blind, Active-comparator), which is not on this map. Cited by 123 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
123citing papers in PubMed, 14 pooled it
17.1field-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.

NCT02952092 phase3completednot on this map

A Phase 3, Multi-center, Randomized, 2-arm Parallel, Double-blind, Active-comparator (Darbepoetin Alfa) Conversion Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia

TypeinterventionalSponsorAstellas Pharma IncRan2016 to 2018Enrolled303ConditionsHemodialysis Chronic Kidney Disease Patients With AnemiaArmsroxadustat, Darbepoetin alfa
3 · Its place in the literature

Who cites it

123 citing papers in PubMed, 14 syntheses or guidelines pooled it, 194 citations in OpenAlex.

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  13. Guideline
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  19. Factors affecting the doses of roxadustat vs darbepoetin alfa for anemia treatment in hemodialysis patients.Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy · 2021
    Trial
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63 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 2 countries.

Tadao AkizawaDepartment of Nephrology, Showa University School of Medicine, Tokyo, Japan akizawa@med.showa-u.ac.jp.
Manabu IwasakiDepartment of Data Science, Yokohama City University, Yokohama, Japan.
Yusuke YamaguchiJapan-Asia Data Science, Development, Astellas Pharma, Inc., Tokyo, Japan.
Yoshikatsu MajikawaJapan-Asia Clinical Development 2, Development, Astellas Pharma, Inc., Tokyo, Japan.
Michael ReuschDevelopment Medical Science Urology and Nephrology, Astellas Pharma Europe B.V., Leiden, The Netherlands.
Astellas Pharma (Japan) · JPAstellas Pharma (Netherlands) · NLShowa University · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRoxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved in China for dialysis-dependent CKD anemia.

methodsThis phase 3, 24-week, double-blind, double-dummy study evaluated roxadustat's noninferiority to darbepoetin alfa for hemodialysis-dependent CKD anemia. We randomly assigned Japanese patients to oral roxadustat three times weekly or to darbepoetin alfa injections once weekly, titrating doses to maintain hemoglobin between 10-12 g/dl. The primary end point was change of average hemoglobin from baseline to weeks 18-24 (

resultsWe randomly assigned 303 patients to roxadustat (

conclusionsRoxadustat maintained hemoglobin within 10-12 g/dl in patients on hemodialysis and was noninferior to darbepoetin alfa. Treatment-emergent adverse events were consistent with previous reports. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients with Anemia, NCT02952092 (ClinicalTrials.gov).

Indexed as

AdultAgedAged, 80 and overAnemiaContusionsDarbepoetin alfaDiarrheaDouble-Blind MethodFemaleFerritinsGlycineHematinicsHemoglobinsHepcidinsHumansIronDarbepoetin alfaFerritinsGlycineHematinicsHemoglobinsHepcidinsIronIsoquinolinesroxadustatTransferrinanemiachronic kidney diseaseclinical trialdarbepoetin alfahemodialysisroxadustat

Identifiers

PMID32493693
PMCPMC7350993
OpenAlexW3030295536

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.