Evidence map›Paper›PMID 37095342›Full record

Trial reportClinical and experimental nephrology2023

Treatment satisfaction with molidustat in CKD-related anemia in non-dialysis patients: a post-hoc analysis of two clinical trials.

Hiroyasu Yamamoto, Takashi Yamada, Ken Miyazaki, Takuto Yamashita, Takuya Kato, Kenichi Ohara, Yusuke Nakamura, Tadao Akizawa

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Clinical and experimental nephrology, 2023. 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 29% 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.

NCT03350321 phase3completednot on this map

A Randomized, Open-label, Active-controlled, Parallel-group, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Comparison to Darbepoetin Alfa in Non-dialysis Subjects With Renal Anemia Who Are Not Treated With Erythropoiesis-Stimulating Agents (ESAs)

TypeinterventionalSponsorBayerRan2017 to 2019Enrolled162ConditionsAnemia, Renal Insufficiency, ChronicArmsMolidustat (BAY85-3934), Darbepoetin alfa
NCT03350347 phase3completednot on this map

A Randomized, Open-label, Active-controlled, Parallel-group, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Comparison to Darbepoetin Alfa in Non-dialysis Subjects Previously Treated With Erythropoiesis-Stimulating Agents (ESAs)

TypeinterventionalSponsorBayerRan2017 to 2019Enrolled164ConditionsAnemia, Renal Insufficiency, ChronicArmsMolidustat (BAY85-3934), Darbepoetin alfa
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. 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

8 authors at 3 institutions in 1 country.

Hiroyasu YamamotoDivision of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-Ku, Tokyo, 105-8461, Japan.ORCID http://orcid.org/0000-0002-5169-0350
Takashi YamadaResearch and Development, Bayer Yakuhin Ltd, 2-4-9 Umeda, Kita-Ku, Osaka, 530-0001, Japan.
Ken MiyazakiResearch and Development, Bayer Yakuhin Ltd, 2-4-9 Umeda, Kita-Ku, Osaka, 530-0001, Japan.
Takuto YamashitaResearch and Development, Bayer Yakuhin Ltd, 2-4-9 Umeda, Kita-Ku, Osaka, 530-0001, Japan.
Takuya KatoResearch and Development, Bayer Yakuhin Ltd, 2-4-9 Umeda, Kita-Ku, Osaka, 530-0001, Japan.
Kenichi OharaMarket Access, Bayer Yakuhin Ltd, Marunouchi Kitaguchi Bldg. 1-6-5, Marunouchi, Chiyoda-Ku, Tokyo, 100-8265, Japan. kenichi.ohara@bayer.com.ORCID http://orcid.org/0000-0003-4513-390X
Yusuke NakamuraMarket Access, Bayer Yakuhin Ltd, Marunouchi Kitaguchi Bldg. 1-6-5, Marunouchi, Chiyoda-Ku, Tokyo, 100-8265, Japan.
Tadao AkizawaShowa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-Ku, Tokyo, 142-8555, Japan.ORCID http://orcid.org/0000-0002-6150-9201
Bayer (Japan) · JPJikei University School of Medicine · JPShowa University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundErythropoiesis-stimulating agents (ESAs) are the standard treatment for patients with renal anemia to increase hemoglobin (Hb) levels and reduce the need for blood transfusions. However, treatments targeting high Hb levels require high doses of ESAs administered intravenously, which is associated with an elevated risk of adverse cardiovascular events. Furthermore, there have been some problems such as hemoglobin variability and low achievement of target hemoglobin due to the shorter half-lives of ESAs. Consequently, erythropoietin-promoting medications, such as hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitors, have been developed. This study aimed to evaluate changes in the Treatment Satisfaction Questionnaire for Medicine version II (TSQM-II) domain scores relative to baseline in each trial, to assess patient satisfaction with molidustat versus darbepoetin alfa.

methodsThis post-hoc analysis of two clinical trials compared treatment satisfaction with an HIF-PH inhibitor, molidustat, versus a standard ESA, darbepoetin alfa, as part of therapy in patients with non-dialysis chronic kidney disease (CKD) and renal anemia.

resultsExploratory outcome data using the TSQM-II showed that both arms in both trials had enhanced treatment satisfaction over the course of the study period, as well as improvements in most TSQM-II domains at week 24 of treatment. Molidustat was associated with convenience domain scores at multiple time points depending on the trial. More patients were highly satisfied with the convenience of molidustat than that of darbepoetin alfa. Patients treated with molidustat had increased global satisfaction domain scores compared with those treated with darbepoetin alfa; however, the differences in global satisfaction domain scores were not significant.

conclusionThese patient-reported satisfaction outcomes support the use of molidustat as a patient-centered treatment option for CKD-related anemia. REGISTRATION OF CLINICAL TRIALS: ClinicalTrials.gov Identifier: NCT03350321 (November 22, 2017). CLINICALTRIALS: gov Identifier: NCT03350347 (November 22, 2017).

Indexed as

AnemiaErythropoietinHematinicsRenal Insufficiency, ChronicChronic DiseaseDarbepoetin alfaHemoglobinsHumansPatient SatisfactionPyrazolesTriazolesDarbepoetin alfaErythropoietinHematinicsHemoglobinsmolidustatPyrazolesTriazolesCKD (chronic kidney disease)Clinical trialsMolidustatRenal anemiaTreatment satisfaction

Identifiers

PMID37095342
PMCPMC10352152
OpenAlexW4366823198

What OpenQuestion holds

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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.