Evidence map›Paper›PMID 34307976›Full record

ArticleKidney international reports2021

Phase 3 Study of Roxadustat to Treat Anemia in Non-Dialysis-Dependant CKD.

Tadao Akizawa, Manabu Iwasaki, Tetsuro Otsuka, Yusuke Yamaguchi, Michael Reusch

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Kidney international reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 10 pooled it
6.7field-weighted citation impact, top 3% 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

47 citing papers in PubMed, 10 syntheses or guidelines pooled it, 62 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

5 authors at 4 institutions in 2 countries.

Tadao AkizawaShowa University School of Medicine, Tokyo, Japan.
Manabu IwasakiDepartment of Data Science, Yokohama City University, Yokohama, Japan.
Tetsuro OtsukaJapan-Asia Clinical Development, Astellas Pharma, Inc., Tokyo, Japan.
Yusuke YamaguchiData Science, Development, Astellas Pharma, Inc., Tokyo, Japan.
Michael ReuschAstellas 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

introductionRoxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that has demonstrated safety and efficacy versus placebo in phase III trials in patients with anemia of chronic kidney disease (CKD) who were not on dialysis (NDD).

methodsThis was a phase III, active-controlled, multicenter, partially randomized, open-label study in Japanese patients with NDD CKD. Patients who had used recombinant human erythropoietin or darbepoetin alfa (DA) before conversion were randomized to roxadustat or DA (comparative arms). Patients who had used epoetin beta pegol before conversion were allocated to roxadustat (reference arm). The primary endpoint was change in average hemoglobin (Hb) level from baseline during the evaluation period (Weeks 18-24). Longer term efficacy and safety were evaluated in roxadustat-treated patients over 52 weeks.

resultsIn this study, 334 patients were randomized/allocated to receive treatment (

conclusionRoxadustat maintained Hb within 10 to 12 g/dl in NDD CKD patients and was noninferior to DA. The safety profiles observed in this study are consistent with previous studies performed in this patient population.

Indexed as

active comparatoranemiachronic kidney diseaseconversionnon–dialysis dependentroxadustat

Identifiers

PMID34307976
PMCPMC8258605
OpenAlexW3155406879

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.