Evidence map›Paper›PMID 34390314›Full record

ArticleTherapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy2022

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.

Tadao Akizawa, Masaomi Nangaku, Takuhiro Yamaguchi, Ryosuke Koretomo, Kazuo Maeda, Osamu Yamada, Hideki Hirakata

Open access · hybridAbstract read
In one paragraph

Article 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, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
2.5field-weighted citation impact, top 10% 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

14 citing papers in PubMed, 21 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors and Iron Metabolism.International journal of molecular sciences · 2023
    Review
  8. Review
  9. 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
  10. 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
  11. Review
  12. Review
  13. Article
  14. 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

7 authors at 5 institutions in 2 countries.

Tadao AkizawaDivision of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.ORCID https://orcid.org/0000-0002-6150-9201
Masaomi NangakuDivision of Nephrology and Endocrinology, The University of Tokyo, Tokyo, Japan.
Takuhiro YamaguchiDivision of Biostatistics, Tohoku University Graduate School of Medicine, Miyagi, Japan.
Ryosuke KoretomoPharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.
Kazuo MaedaPharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.
Osamu YamadaPharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.ORCID https://orcid.org/0000-0001-9441-2951
Hideki HirakataFukuoka Renal Clinic, Fukuoka, Japan.
Japan Tobacco (United States) · USOno Clinic · JPShowa University · JPThe University of Tokyo · JPTohoku University · JP

Funding

Japan Tobacco Inc.Torii Pharmaceutical Co. Ltd.
6 · The paper itself

Abstract

Enarodustat (JTZ-951) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor developed for treating anemia in chronic kidney disease. Two open-label, uncontrolled phase 3 studies evaluated the 52-week safety and efficacy of enarodustat in Japanese anemic patients with chronic kidney disease not on dialysis (n = 132) [SYMPHONY ND-Long study] or on maintenance hemodialysis (n = 136) [SYMPHONY HD-Long study]. The most frequent adverse events were viral upper respiratory tract infection (25.8%) followed by chronic kidney disease (8.3%) in the SYMPHONY ND-Long study, and viral upper respiratory tract infection (49.3%) followed by contusion (16.9%) and diarrhea (16.9%) in the SYMPHONY HD-Long study. The incidence of any adverse events did not increase over time. Mean hemoglobin levels and 95% confidence intervals were maintained within the target range (10.0-12.0 g/dl) over 52 weeks in both studies. The long-term safety and efficacy of enarodustat were confirmed in Japanese anemic patients with chronic kidney disease.

Indexed as

AnemiaRenal Insufficiency, ChronicHemoglobinsHumansHypoxia-Inducible Factor-Proline DioxygenasesJapanN-substituted GlycinesPyridinesRenal DialysisTriazolesenarodustatHemoglobinsHypoxia-Inducible Factor-Proline DioxygenasesN-substituted GlycinesPyridinesTriazolesanemiachronic kidney diseaseenarodustathypoxia-inducible factor prolyl hydroxylase inhibitorlong-term study

Identifiers

PMID34390314
PMCPMC9290460
OpenAlexW3192679673

What OpenQuestion holds

Textmetadata
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.