Evidence map›Paper›PMID 38530490›Full record

Trial reportClinical and experimental nephrology2024

Factors affecting responsiveness of vadadustat in patients with anemia associated with chronic kidney disease: a post-hoc subgroup analysis of Japanese phase 3 randomized studies.

Masaomi Nangaku, Kiichiro Ueta, Kenichi Nishimura, Kazuyo Sasaki, Takafumi Hashimoto

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical and experimental nephrology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
3.2field-weighted citation impact, top 8% 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.

NCT03329196 phase3completednot on this map

A Phase III, Open-label, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

TypeinterventionalSponsorTanabe Pharma CorporationRan2017 to 2019Enrolled304ConditionsAnemia, Non-dialysis Dependent Chronic Kidney DiseaseArmsMT-6548, Darbepoetin alfa
NCT03439137 phase3completednot on this map

A Phase III, Double Blind, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

TypeinterventionalSponsorTanabe Pharma CorporationRan2018 to 2019Enrolled323ConditionsAnemia, Hemodialysis Dependent Chronic Kidney DiseaseArmsMT-6548, Darbepoetin alfa, MT-6548-matching placebo, Darbepoetin alfa-matching placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 7 citations in OpenAlex.

  1. Impact of SLCO1B1 Gene Polymorphisms on Vadadustat Pharmacokinetics.European journal of drug metabolism and pharmacokinetics · 2026
    Observational
  2. Article
  3. Observational
  4. Article
  5. Review
  6. Observational
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  8. 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

5 authors at 3 institutions in 1 country.

Masaomi NangakuGraduate School of Medicine, The University of Tokyo, Tokyo, Japan.ORCID http://orcid.org/0000-0001-7401-2934
Kiichiro UetaMitsubishi Tanabe Pharma Corporation, Tokyo, Japan. ueta.kiichiro@mf.mt-pharma.co.jp.ORCID http://orcid.org/0000-0002-3489-6971
Kenichi NishimuraMitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Kazuyo SasakiMitsubishi Tanabe Pharma Corporation, Tokyo, Japan.ORCID http://orcid.org/0000-0001-5267-8284
Takafumi HashimotoMitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Mitsubishi Tanabe Pharma CorporationAsahi Kasei (Japan) · JPThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor developed for treating anemia in chronic kidney disease (CKD). The purpose of this post-hoc analysis was to investigate the factors affecting the responsiveness to vadadustat in anemia patients with nondialysis-dependent (NDD) or hemodialysis-dependent (HDD) CKD in two Japanese phase 3 studies.

methodsOf 151 and 162 patients enrolled in NDD-CKD and HDD-CKD studies, 136 and 140 patients, respectively, were included and divided into subgroups for the analysis. To assess vadadustat responsiveness, the resistance index was defined as the mean body weight-adjusted dose of vadadustat (mg/kg) at weeks 20-24 divided by the mean hemoglobin (g/dL) at weeks 20-24. Multivariate analysis was performed to identify the variables affecting the resistance index.

resultsIndependent factors identified as determinants for better response to vadadustat were as follows: high baseline hemoglobin, low baseline eGFR, high week-20-24 ferritin, and CKD not caused by autoimmune disease/glomerulonephritis/vasculitis in NDD-CKD; and male sex, high baseline C-reactive protein, and low baseline erythropoiesis-stimulating agent resistance index (ERI) in HDD-CKD.

conclusionsIn this post-hoc analysis, several factors were identified as affecting the response to vadadustat. These results may provide useful information leading to an appropriate dose modification for vadadustat. CLINICAL

trial registrationNCT03329196 (MT-6548-J01) and NCT03439137 (MT-6548-J03).

Indexed as

AnemiaGlycineHemoglobinsPicolinic AcidsRenal Insufficiency, ChronicAgedDouble-Blind MethodEast Asian PeopleFemaleFerritinsGlomerular Filtration RateHematinicsHumansHypoxia-Inducible Factor-Proline DioxygenasesJapanMaleFerritinsGlycineHematinicsHemoglobinsHypoxia-Inducible Factor-Proline DioxygenasesPicolinic AcidsProlyl-Hydroxylase InhibitorsvadadustatAnemiaChronic kidney diseaseHypoxia-inducible factor prolyl hydroxylase inhibitorResponsivenessSubgroup analysisVadadustat

Identifiers

PMID38530490
PMCPMC11033221
OpenAlexW4393195719

What OpenQuestion holds

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LicenceCC BY
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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.