Evidence map›Paper›PMID 31304637›Full record

Trial reportTherapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy2020

Long-Term Safety and Efficacy of JR-131, a Biosimilar of Darbepoetin Alfa, in Japanese Patients With Renal Anemia Undergoing Hemodialysis: Phase 3 Prospective Study.

Shinichi Nishi, Masayuki Yamada, Kazuhiko Tsuruya, Ikuto Masakane, Hidetomo Nakamoto

Open access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in 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, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 38% 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.

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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
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

5 authors at 5 institutions in 1 country.

Shinichi NishiDivision of Nephrology and Kidney Center, Kobe University Graduate School of Medicine, Kobe, Japan.
Masayuki YamadaData Science Division, Kissei Pharmaceutical Co., Tokyo, Japan.
Kazuhiko TsuruyaDepartment of Nephrology, Nara Medical University, Nara, Japan.
Ikuto MasakaneHoncho Yabuki Clinic, Yamagata, Japan.
Hidetomo NakamotoDepartment of General Internal Medicine, Saitama Medical University, Saitama, Japan.
Kissei Pharmaceutical (Japan) · JPKobe University · JPNara Medical University · JPSaitama Medical University · JPYamagata Research Institute Of Technology · JP

Funding

JCR Pharmaceuticals Co., Ltd.Kissei Pharmaceutical Co., Ltd.
6 · The paper itself

Abstract

The objective of this study was to evaluate the safety and efficacy of JR-131, a biosimilar of darbepoetin alfa, for long-term treatment of renal anemia patients undergoing hemodialysis. In this multicenter, single-arm, phase 3 study, 159 patients with renal anemia who had been receiving darbepoetin alfa or recombinant human erythropoietins were treated with intravenous JR-131 for 52 weeks. In patients receiving darbepoetin alfa, JR-131 was administered at the same dose, while in patients receiving recombinant human erythropoietin the dose was determined based on the 1:200 conversion ratio following the Japanese darbepoetin alfa package insert. No notable adverse drug reactions were reported, and no anti-JR-131 antibodies were detected. The hemoglobin levels were maintained in the range of 10.0-12.0 g/dL throughout the study. JR-131 proved to be a useful and lower-cost alternative to darbepoetin alfa in the management of renal anemia in patients undergoing hemodialysis.

Indexed as

Renal DialysisAdultAgedAged, 80 and overAnemiaBiosimilar PharmaceuticalsDarbepoetin alfaFemaleHematinicsHemoglobinsHumansJapanMaleMiddle AgedProspective StudiesRenal Insufficiency, ChronicBiosimilar PharmaceuticalsDarbepoetin alfaHematinicsHemoglobinsBiosimilarDarbepoetin alfaErythropoiesis-stimulating agentJR-131Long-term study

Identifiers

PMID31304637
PMCPMC7078934
OpenAlexW2957391141

What OpenQuestion holds

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LicenceCC BY-NC
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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.