Evidence map›Paper›PMID 30699415›Full record

Trial reportAmerican journal of nephrology2019

A Placebo-Controlled, Randomized Trial of Enarodustat in Patients with Chronic Kidney Disease Followed by Long-Term Trial.

Tadao Akizawa, Masaomi Nangaku, Takuhiro Yamaguchi, Masanobu Arai, Ryosuke Koretomo, Atsushi Matsui, Hideki Hirakata

Abstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of nephrology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 8 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.

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

38 citing papers in PubMed, 8 syntheses or guidelines pooled it.

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  18. Review
  19. Hypoxia-Inducible Factors and Diabetic Kidney Disease-How Deep Can We Go?International journal of molecular sciences · 2022
    Review
  20. 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
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.

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 AraiJapan Tobacco Inc., Tokyo, Japan.
Ryosuke KoretomoJapan Tobacco Inc., Tokyo, Japan.
Atsushi MatsuiJapan Tobacco Inc., Tokyo, Japan.
Hideki HirakataFukuoka Renal Clinic, Fukuoka, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEnarodustat (JTZ-951) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that mimics adaptive responses to hypoxic conditions and may provide a new therapeutic approach for managing anemia in patients with chronic kidney disease (CKD). We evaluated the efficacy, safety, and maintenance dose of enarodustat in anemic patients with CKD not on dialysis.

methodsErythropoiesis-stimulating agent (ESA) naïve patients (correction group) and patients on a stable dose of ESA (conversion group) were randomized to receive 2, 4, or 6 mg of enarodustat or placebo once daily for 6 weeks in a double-blind manner (Period 1) followed by 24 weeks of open enarodustat treatment to maintain their hemoglobin (Hb) levels within a target range of 10.0-12.0 g/dL in reference to a dose adjustment algorithm (Period 2).

resultsIn the correction group, Hb level increase rate per week increased in a dose-response manner. The proportion of subjects in the conversion group who maintained Hb levels within ± 1.0 g/dL of baseline did not differ between each enarodustat arm and placebo arm during Period 1. Over 70% of subjects in both groups maintained Hb levels within the target range at the end of treatment in Period 2. The mean prescribed doses were 3.58 and 3.74 mg/day in the correction group and the conversion group, respectively. Enarodustat was associated with decreases in hepcidin and ferritin and increased total iron-binding capacity and was generally well tolerated.

conclusionsEnarodustat corrects and maintains Hb levels in anemic patients with CKD not on dialysis.

Indexed as

AgedAged, 80 and overAnemiaDose-Response Relationship, DrugDouble-Blind MethodErythropoietinFemaleFerritinsFollow-Up StudiesHematinicsHemoglobinsHepcidinsHumansHypoxia-Inducible Factor-Proline DioxygenasesJapanKidneyenarodustatErythropoietinFerritinsHematinicsHemoglobinsHepcidinsHypoxia-Inducible Factor-Proline DioxygenasesN-substituted GlycinesPlacebosPyridinesTriazolesAnemia in chronic kidney diseaseEnarodustatHepcidinHypoxia-inducible factor prolyl hydroxylase inhibitorRandomized trial

Identifiers

PMID30699415
PMCPMC6481254

What OpenQuestion holds

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Registered trials

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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.