Evidence map›Paper›PMID 30953333›Full record

Trial reportAdvances in therapy2019

Roxadustat Treatment of Chronic Kidney Disease-Associated Anemia in Japanese Patients Not on Dialysis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial.

Tadao Akizawa, Manabu Iwasaki, Tetsuro Otsuka, Michael Reusch, Toshihiro Misumi

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Advances in therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01964196 (ASP1517 Phase 2 Clinical Trial -A Multi-center, Randomized, Parallel Groups, Placebo-controlled, Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-), which is not on this map. Cited by 60 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 17 pooled it
–field-weighted citation impact
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.

NCT01964196 phase2completednot on this map

ASP1517 Phase 2 Clinical Trial -A Multi-center, Randomized, Parallel Groups, Placebo-controlled, Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-

TypeinterventionalSponsorAstellas Pharma IncRan2013 to 2015Enrolled107ConditionsAnemia in Chronic Kidney Disease Patients Not on DialysisArmsASP1517, Placebo
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 17 syntheses or guidelines pooled it.

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  15. Guideline
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  20. Oral roxadustat three times weekly in ESA-naïve and ESA-converted patients with anemia of chronic kidney disease on hemodialysis: Results from two phase 3 studies.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
    Trial
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.

Tadao AkizawaShowa University School of Medicine, Namics 301, 4-24-51 Takanawa, Minato-ku, Tokyo, Japan. akizawa@med.showa-u.ac.jp.
Manabu IwasakiYokohama City University School of Data Science, Yokohama, Japan.
Tetsuro OtsukaJapan/Asia Clinical Development 2, Astellas Pharma Inc., Tokyo, Japan.
Michael ReuschMedical Science Urology and Nephrology, Astellas Pharma Europe B.V., Leiden, The Netherlands.
Toshihiro MisumiJapan-Asia Data Science, Astellas Pharma Inc., Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis study evaluated efficacy and safety/tolerability of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, in Japanese anemic non-dialysis-dependent chronic kidney disease (NDD-CKD) patients.

methodsIn this phase 2, double-blind, 24-week study, NDD-CKD patients were randomized to oral placebo or roxadustat (50, 70, or 100 mg) three times weekly (TIW) for 6 weeks followed by dose adjustments to maintain hemoglobin (Hb) at 10-12 g/dL for 18 weeks; patients meeting pre-defined criteria were re-randomized to TIW or once-weekly dosing. The primary end point was rate of rise of Hb (g/dL/week) during the first 6 weeks; secondary end points included response rate (Hb ≥ 10.0 g/dL and increase in Hb from baseline ≥ 1 g/dL) and mean Hb and change from baseline in Hb at weeks 18-24. The main safety outcomes were vital signs, laboratory test results, electrocardiograms, and frequency of treatment-emergent adverse events.

resultsOf 107 patients randomized, 83 completed the study. The mean (SD) rate of rise of Hb during the first 6 weeks was - 0.052 (0.142) for placebo and + 0.200 (0.160), + 0.453 (0.256), and + 0.570 (0.240) for roxadustat 50-, 70-, and 100-mg TIW groups, respectively (p < 0.001). Response rate was 14.8% for placebo and 81.5%, 100%, and 100% for roxadustat TIW groups (p < 0.001). Change in Hb from baseline at weeks 18-24 was - 0.17 (0.61) for placebo and + 1.10 (0.71), + 1.33 (0.82), and + 1.55 (0.88) g/dL for roxadustat TIW groups (p < 0.001). No deaths or major adverse cardiac events occurred with roxadustat.

conclusionRoxadustat was well tolerated and effective in correcting Hb levels within 6 weeks in Japanese anemic NDD-CKD patients.

trial registrationClinicalTrials.gov: NCT01964196. Registered 15 October 2013 (retrospectively registered).

fundingAstellas Pharma Inc.

Indexed as

AdultAgedAnemiaChronic DiseaseDouble-Blind MethodFemaleGlycineHumansIsoquinolinesJapanMaleMiddle AgedPlacebo EffectRenal Insufficiency, ChronicGlycineIsoquinolinesroxadustatAnemiaCKDClinical trialHemoglobinNephrologyRoxadustat

Identifiers

PMID30953333
PMCPMC6824366

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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.