Evidence map›Paper›PMID 31117088›Full record

Trial reportNephron2019

Enarodustat, Conversion and Maintenance Therapy for Anemia in Hemodialysis Patients: A Randomized, Placebo-Controlled Phase 2b Trial Followed by Long-Term Trial.

Tadao Akizawa, Masaomi Nangaku, Takuhiro Yamaguchi, Masanobu Arai, Ryosuke Koretomo, Kazuo Maeda, Yuya Miyazawa, Hideki Hirakata

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nephron, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 4 pooled it
5.2field-weighted citation impact, top 4% 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

29 citing papers in PubMed, 4 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
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  17. Treatment of anemia associated with chronic kidney disease with the HIF prolyl hydroxylase inhibitor enarodustat: A review of the evidence.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 · 2022
    Review
  18. Two long-term phase 3 studies of enarodustat (JTZ-951) in Japanese anemic patients with chronic kidney disease not on dialysis or on maintenance hemodialysis: SYMPHONY ND-Long and HD-Long 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 · 2022
    Article
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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

8 authors at 5 institutions in 1 country.

Tadao AkizawaDivision of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan, akizawa@med.showa-u.ac.jp.
Masaomi NangakuDivision of Nephrology and Endocrinology, The University of Tokyo, Tokyo, Japan.
Takuhiro YamaguchiDivision of Biostatistics, Tohoku University Graduate School of Medicine, Miyagi, Japan.
Masanobu AraiPharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.
Ryosuke KoretomoPharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.
Kazuo MaedaPharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.
Yuya MiyazawaPharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.
Hideki HirakataFukuoka Renal Clinic, Fukuoka, Japan.
Japan Tobacco (Japan) · JPOno Clinic · JPShowa University · JPThe University of Tokyo · JPTohoku University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEnarodustat (JTZ-951) is an orally available hypoxia-inducible factor prolyl hydroxylase inhibitor that increases endogenous erythropoietin levels in the treatment of anemia associated with chronic kidney disease (CKD).

objectiveA phase 2b study of enarodustat to assess the hemoglobin (Hb) response, safety, and maintenance dosage was conducted in Japanese anemic patients with hemodialysis-dependent CKD.

methodsSubjects receiving a stable dose of an erythropoiesis-stimulating agent were randomized to receive once-daily enarodustat at a dose of 2, 4, or 6 mg or placebo in a double-blind manner for 6 weeks (Period 1) followed by 24-week open treatment with enarodustat, adjusted in the range of 2-8 mg to maintain Hb within a target range (10.0-12.0 g/dL; Period 2).

resultsChange in Hb from baseline increased with enarodustat dose in Period 1. In Period 2, the proportion of subjects who maintained their Hb level within the target range at the end of treatment was 65.1%. To maintain Hb levels within the target range over the course of Period 2, approximately 80% of subjects required 2 dose adjustments or fewer. Enarodustat decreased hepcidin and ferritin levels, increased total iron-binding capacity, and was generally well tolerated.

conclusionsEnarodustat corrected and maintained Hb levels in anemic patients with hemodialysis-dependent CKD. Phase 3 studies of enarodustat are currently ongoing.

Indexed as

Renal DialysisAgedAnemiaDose-Response Relationship, DrugDouble-Blind MethodEnzyme InhibitorsFemaleFerritinsHemoglobinsHepcidinsHumansHypoxia-Inducible Factor-Proline DioxygenasesMaleMiddle AgedN-substituted GlycinesPyridinesenarodustatEnzyme InhibitorsFerritinsHemoglobinsHepcidinsHypoxia-Inducible Factor-Proline DioxygenasesN-substituted GlycinesPyridinesTriazolesAnemia in chronic kidney diseaseEnarodustatHepcidinHypoxia-inducible factor prolyl hydroxylase inhibitorRandomized trial

Identifiers

PMID31117088
PMCPMC6878752
OpenAlexW2946106947

What OpenQuestion holds

Textmetadata
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.