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Clinical Trial
. 2023 Aug;27(8):651-659.
doi: 10.1007/s10157-023-02353-x. Epub 2023 Apr 24.

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

Hiroyasu Yamamoto  1 , Takashi Yamada  2 , Ken Miyazaki  2 , Takuto Yamashita  2 , Takuya Kato  2 , Kenichi Ohara  3 , Yusuke Nakamura  4 , Tadao Akizawa  5
Affiliations
Clinical Trial

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

Hiroyasu Yamamoto et al. Clin Exp Nephrol. 2023 Aug.

Abstract

Background: Erythropoiesis-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.

Methods: This 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.

Results: Exploratory 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.

Conclusion: These 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).

Keywords: CKD (chronic kidney disease); Clinical trials; Molidustat; Renal anemia; Treatment satisfaction.

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Conflict of interest statement

H.Y. received consulting and lecture fees from Bayer Yakuhin, Ltd., Kyowa Kirin Co Ltd., and Astellas Pharma Inc. during the study. T.Y., K.M., T.Y., T. K., K.O., and Y.N. are employees of Bayer Yakuhin, Ltd. T.A. received consulting and lecture fees from Bayer Yakuhin, Japan Tobacco, Astellas Pharma Inc., GlaxoSmithKline, Torii Pharmaceutical, Kyowa Kirin Co Ltd, Kissei, Mitsubishi Tanabe, and Chugai during the study.

Figures

Fig. 1
Fig. 1
Overall study design for TSQM-II evaluation in both trials. TSQM-II Treatment Satisfaction Questionnaire for Medicine version II
Fig. 2
Fig. 2
TSQM-II mean domain scores for MIYABI ND-C. Bold indicates significant (p < 0.05) improvement at the evaluation timepoint compared to baseline. TSQM-II Treatment Satisfaction Questionnaire for Medicine version II, MIYABI molidustat once daily improved renal anemia by inducing EPO, ND-C non-dialysis correction
Fig. 3
Fig. 3
TSQM-II mean domain scores for MIYABI ND-M. *Indicates significant improvement at the evaluation timepoint compared to baseline. TSQM-II Treatment Satisfaction Questionnaire for Medicine version II, MIYABI molidustat once daily improved renal anemia by inducing EPO, ND-C non-dialysis correction
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