Evidence map›Paper›PMID 34115437›Full record

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

A phase 3, open-label, single-arm study of vadadustat for anemia in chronic kidney disease for Japanese patients on hemodialysis not receiving erythropoiesis-stimulating agents.

Masaomi Nangaku, Kazuoki Kondo, Souichirou Takabe, Kiichiro Ueta, Tsubasa Tandai, Yutaka Kawaguchi, Yasuhiro Komatsu

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report 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. It is linked to trial NCT03461146 (A Phase III, Open-label Study of MT-6548 in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 22% 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.

NCT03461146 phase3completednot on this map

A Phase III, Open-label Study of MT-6548 in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

TypeinterventionalSponsorTanabe Pharma CorporationRan2018 to 2018Enrolled24ConditionsAnemia, Hemodialysis Dependent Chronic Kidney DiseaseArmsMT-6548
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. A phase 3, open-label, single-arm study of vadadustat for anemia in chronic kidney disease for Japanese patients on hemodialysis not receiving erythropoiesis-stimulating agents.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
    Trial
  2. Article
  3. Observational
  4. Single-arm clinical trials: design, ethics, principles.BMJ supportive & palliative care · 2024
    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 at 3 institutions in 1 country.

Masaomi NangakuGraduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Kazuoki KondoMitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Souichirou TakabeMitsubishi Tanabe Pharma Corporation, Tokyo, Japan.ORCID https://orcid.org/0000-0001-9132-2109
Kiichiro UetaMitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Tsubasa TandaiMitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Yutaka KawaguchiMitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Yasuhiro KomatsuGraduate School of Medicine, Gunma University, Maebashi, Gunma, Japan.
Mitsubishi Group (Japan) · JPGunma University · JPThe University of Tokyo · JP

Funding

Mitsubishi Tanabe Pharma Corporation
6 · The paper itself

Abstract

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved in Japan for the treatment of anemia in patients with chronic kidney disease (CKD). This phase 3, open-label, single-arm study evaluated the efficacy and safety of vadadustat in 24 Japanese patients with CKD-associated anemia on hemodialysis who were not receiving erythropoiesis-stimulating agents (ESAs). Patients received vadadustat for 24 weeks; the starting dose was 300 mg/day and doses were adjusted to achieve the target hemoglobin (Hb) range of 10.0-12.0 g/dL. The least squares mean of average Hb at Weeks 20 and 24 (95% confidence interval) was 10.75 g/dL (10.35, 11.14). The most common adverse event was shunt stenosis (25.0%). Adverse drug reactions (diarrhea and vomiting) occurred in two patients (8.3%) and the severity was mild. Vadadustat increased and maintained Hb levels within the target range and was generally well-tolerated in Japanese patients with anemia on hemodialysis not receiving ESAs.

Indexed as

AnemiaFemaleGlycineHematinicsHumansJapanMaleMiddle AgedPicolinic AcidsRenal DialysisRenal Insufficiency, ChronicTreatment OutcomeGlycineHematinicsPicolinic Acidsvadadustatanemiachronic kidney diseasehemodialysishypoxia-inducible factor prolyl hydroxylase inhibitorvadadustat

Identifiers

PMID34115437
PMCPMC9292398
OpenAlexW3168957587

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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 Socratic graph.