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Article History

Received: 23 September 2025

Accepted: 18 February 2026

First Online: 26 March 2026

Declarations

:

: This study was conducted in accordance with the Declaration of Helsinki and the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects (23 March 2021; partially revised 27 March 2023) issued by the Ministry of Education, Culture, Sports, Science and Technology; Ministry of Health, Labor and Welfare; and Ministry of Economy, Trade and Industry in Japan. All patients provided informed consent prior to inclusion in the study. The study protocol, amendments, and other relevant documents were approved by the independent ethics committee/institutional review board of the nonprofit organization MINS (Tokyo, Japan; Approval No. MINS-REC-240211) and hospital director of each site before the start of the study.

: Not applicable.

: YE has received honoraria for Astellas Pharma, Bristol Myers Squibb, Merck Biopharma, Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, MSD, Nippon Kayaku, and Ono Pharma. HK has participated in consulting or advisory roles for Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Chugai Pharmaceutical, Eisai, Ferring, Janssen, Kissei, MSD, Pfizer, and Takeda; has received speakers bureaus fees from Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Janssen, Merck, MSD, Sanofi, and Takeda; and has received institutional research funding from AstraZeneca, Bristol Meyers Squibb, and MSD. SS has received speakers bureaus fees from Bristol Myers Squibb and Ono Pharmaceutical. KY has received honoraria for lectures from Astellas Pharma, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Eisai, Eli Lilly, Fuji Film Pharma, Jansen, Merck Biopharma, Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, MSD, Novartis, Ono Pharma, PDR Pharma, Pfizer, Sanofi, and Takeda; has received fees for advisory boards from AstraZeneca, Eisai, Genmab, Gilead, Henlius, MSD, Novartis, OncXerna, Sanofi, and Takeda; has received institutional research funding from AstraZeneca, Boehringer Ingelheim, Chugai Pharmaceutical, Daiichi Sankyo, Eisai, Eli Lilly, Genmab, Haihe Biopharma, Kyowa Hakko Kirin, Merck Biopharma, Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, MSD, Nihon Kayaku, Novartis, Ono Pharmaceutical, Pfizer, Sanofi, Seagen, Taiho Pharmaceutical, and Takeda; has received fees for being principal investigator from AstraZeneca, Boehringer Ingelheim, Chugai Pharmaceutical, Daiichi Sankyo, Eisai, Eli Lilly, Genmab, Haihe, Kyowa Hakko Kirin, Merck Biopharma, Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, MSD, Nihon Kayaku, Novartis, Ono Pharmaceutical, Pfizer, Sanofi, Seagen, Taiho Pharmaceutical, and Takeda. KFujimoto has received speakers bureau fees from Astellas Pharma, Bayer Yakuhin, Janssen, Kissei, Merck, MSD, Nippon Kayaku, and Ono Pharmaceutical; has received institutional research funding from AstraZeneca, Bristol Myers Squibb, Eisai, Janssen, Kissei, MSD, SBI Pharma, and Tsumura; and has received scholarship grants from I&H. TNakagawa has received speakers bureau fees from Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Janssen, and Ono Pharmaceutical; and has received institutional research funding from Terumo Life Science Foundation. SH has received speakers bureau fees from AstraZeneca, Janssen, and Merck; has received institutional research funding from Nipro Corporation and Oyokyo Kidney Research Institute Hirosaki Hospital; and has received scholarship grants from Kaneka Medix Corporation. NMasumori has received speakers bureau fees from Astellas Pharma, AstraZeneca, Bayer, Janssen, Kissei, Ono Pharmaceutical, and Takeda; and has received institutional research funding from Astellas Pharma, Bristol Myers Squibb, Japan Tobacco, MSD, and Ono Pharmaceutical. SN has received speakers bureau fees from Bristol Myers Squibb. KFujita has received speakers bureau fees from Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Janssen, MSD, and Ono Pharmaceutical; and has received institutional research funding from Pfizer. NMiura has received speakers bureau fees from MSD. JF has received speakers bureau fees from Bristol Myers Squibb, Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, and MSD. MS reports employment with Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA. TK has participated in consulting or advisory roles for Astellas Pharma, AstraZeneca, Bayer, Chugai Pharmaceutical, Medicaroid, MSD, Nippon Kayaku, and Janssen; has participated in speakers bureaus for Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb, Ono Pharmaceutical, Chugai Pharmaceutical, Janssen, Kissei, Merck, MSD, Nippon Kayaku, Nippon Shinyaku, Pfizer, Sanofi, and Takeda; and has received institutional research funding from Astellas Pharma, AstraZeneca, Bayer, and Chugai Pharmaceutical. EK has participated in consulting or advisory roles for Astellas Pharma, AstraZeneca, Ferring Pharma, Merck BioPharma, Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, Janssen Pharma, Chugai Pharma, and MSD; has participated in speakers bureaus for Astellas Pharma, AstraZeneca, Merck BioPharma, Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, Janssen Pharma, MSD, Bristol Myers Squibb, Chugai Pharma, Nippon Kayaku, Eisai, Bayer Pharma, Kyorin Pharma, and Takeda Pharma; and has received institutional research funding from MSD, Kyorin Pharma, Nippon Kayaku, Chugai Pharma, Astellas Pharma, AstraZeneca, Bristol Myers Squibb, and Merck BioPharma, Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA.