Eriguchi, Masahiro
Ito, Yasuhiko
Yoshida, Hisako
Matsui, Masaru
Kosugi, Takaaki
Nagashima, Ai
Tagami, Genri
Yamada, Shohei
Sakurada, Tsutomu
Nakagaki, Masahiro
Harada, Kenji
Kurahashi, Satoshi
Toda, Naohiro
Ototake, Satoshi
Mizuno, Masashi
Kadoya, Hiroyuki
Kishi, Seiji
Kunoki, Shunnosuke
Sakai, Yukinao
Sato, Yuichi
Hashimoto, Koji
Matsunami, Masatoshi
Suzuki, Tomo
Takahashi, Shunsuke
Nakata, Kenji
Koibuchi, Kiyoto
Oka, Hideaki
Kamimura, Taro
Matsumoto, Hidenobu
Yoshida, Takeshi
Tsuruya, Kazuhiko
Funding for this research was provided by:
Clinical Research Grant Program at Nara Medical University (JHR2400003)
the Public Research Grant from the Japanese Association of Dialysis Physicians (JADP grant 2024-8)
Fuji Systems Corporation
Article History
Received: 21 July 2025
Accepted: 19 October 2025
First Online: 17 December 2025
Declarations
:
: The silver CAPD catheter has been certified by the Pharmaceuticals and Medical Devices Agency in Japan. The study protocol and informed consent documents were approved by the Certified Review Board, with Nara Medical University as the principal research institution (approval number: nara0065) on March 12, 2025. Ethical approval for participating sites was completed by the end of April 2025. The ASCA-PD study is being conducted in accordance with the International Conference on Harmonization Good Clinical Practice guidelines, the key principles of ethical conduct in research, and the Declaration of Helsinki. Any important protocol modifications (e.g., changes to eligibility criteria, outcomes, or analyses) will be promptly communicated to all relevant parties, including the principal investigator, the research ethics committee, the Certified Review Board, the jRCTs, and the Ministry of Health, Labour and Welfare of Japan. Based on these approvals, the study has been initiated at each participating site after obtaining implementation permission from the respective institutions. Written informed consent is obtained from all study participants by the site principal investigator or a sub-investigator, according to the Declaration of Helsinki. The sponsor has no role in study design, data collection, data assembly, or analysis.
: Consent for publication is not applicable.
: The authors declare no conflicts of interest related to this study. All researchers conducted this study as part of their academic research activities. Fuji Systems Corporation provided technical support but had no role in the study design, data collection, analysis, interpretation, or manuscript preparation.