Evidence map›Paper›PMID 33283981›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 Therapy2021

Vadadustat for anemia in chronic kidney disease patients on peritoneal dialysis: A phase 3 open-label study in Japan.

Masaomi Nangaku, Kazuoki Kondo, Souichirou Takabe, Kiichiro Ueta, Genki Kaneko, Makiko Otsuka, Yutaka Kawaguchi, Yasuhiro Komatsu

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase III
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, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03402386 (A Phase III, Open-label Study of MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.8field-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.

NCT03402386 phase3completednot on this map

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

TypeinterventionalSponsorTanabe Pharma CorporationRan2018 to 2018Enrolled42ConditionsAnemia, Peritoneal Dialysis Dependent Chronic Kidney DiseaseArmsMT-6548
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 25 citations in OpenAlex.

  1. Vadadustat for treatment of anemia in patients with dialysis-dependent chronic kidney disease receiving peritoneal dialysis.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2023
    Trial
  2. 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
  3. Vadadustat for anemia in chronic kidney disease patients on peritoneal dialysis: A phase 3 open-label study in Japan.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 · 2021
    Trial
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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 3 institutions in 1 country.

Masaomi NangakuGraduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Kazuoki KondoIntegrated Value Development Division, Medical Intelligence Department, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Souichirou TakabeIntegrated Value Development Division, Medical Intelligence Department, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.ORCID https://orcid.org/0000-0001-9132-2109
Kiichiro UetaIntegrated Value Development Division, Medical Intelligence Department, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Genki KanekoIntegrated Value Development Division, Medical Intelligence Department, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Makiko OtsukaIntegrated Value Development Division, Medical Intelligence Department, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Yutaka KawaguchiIntegrated Value Development Division, Medical Intelligence Department, Mitsubishi 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 Not applicable
6 · The paper itself

Abstract

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia in patients with chronic kidney disease (CKD). This phase 3, open-label, 24-week single-arm study evaluated the efficacy and safety of vadadustat in 42 Japanese CKD patients with anemia undergoing peritoneal dialysis. Patients received oral vadadustat for 24 weeks, initiated at 300 mg/day and doses were adjusted to achieve the target hemoglobin (Hb) range of 11.0-13.0 g/dL. Least squares mean of average Hb at weeks 20 and 24 was 11.35 g/dL, which was within the target range. The most frequent adverse events were catheter site infections (23.8%), which were not related to vadadustat treatment. Vadadustat was generally well tolerated and effective in controlling Hb levels within the target range, indicating the usefulness of vadadustat for treating anemia in Japanese CKD patients undergoing peritoneal dialysis.

Indexed as

AnemiaFemaleGlycineHumansJapanMaleMiddle AgedPeritoneal DialysisPicolinic AcidsRenal Insufficiency, ChronicTreatment OutcomeGlycinePicolinic Acidsvadadustatanemiachronic kidney diseasehypoxia-inducible factor prolyl hydroxylase inhibitorperitoneal dialysisvadadustat

Identifiers

PMID33283981
PMCPMC8451920
OpenAlexW3113094759

What OpenQuestion 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 OpenQuestion graph.