Rituximab for Relapsing Nephrotic Syndrome in Adults: A Randomized Clinical Trial

Isaka, Yoshitaka; Sakaguchi, Yusuke; Shinzawa, Maki; Maruyama, Shoichi; Sakaguchi, Mika; Hayashi, Hiroki; Kaida, Yusuke; Goto, Shin; Tsukamoto, Tatsuo; Maeshima, Akito; Ikeda, Yoichiro; Sakai, Norihiko; Sawa, Naoki; Furuichi, Kengo; Yamagata, Kunihiro; Wada, Takehiko; Shibagaki, Yugo; Hiromura, Keiju

doi:https://doi.org/10.1001/jama.2025.19316

Rituximab for Relapsing Nephrotic Syndrome in Adults: A Randomized Clinical Trial

Isaka, Yoshitaka; Sakaguchi, Yusuke; Shinzawa, Maki et al.

JAMA, 2025

アクセス数:501件（2026-02-15 21:36 集計）

固定URL: https://hdl.handle.net/11094/103337

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タイトル	Rituximab for Relapsing Nephrotic Syndrome in Adults: A Randomized Clinical Trial
著者	NRID 1000000379166 1000000379166 ORCID 0000-0002-0820-7167 0000-0002-0820-7167 researchmap permalink isaka-handai3857 isaka-handai3857 Scopus Author ID 16207611100 16207611100 著者名 Isaka, Yoshitaka
	NRID 1000080756817 1000080756817 ORCID 0000-0002-0987-5423 0000-0002-0987-5423 researchmap permalink sakaguchi-handai3857 sakaguchi-handai3857 Scopus Author ID 35183980700 35183980700 著者名 Sakaguchi, Yusuke
	NRID 1000030704788 1000030704788 ORCID 0000-0002-7739-893X 0000-0002-7739-893X researchmap permalink 7000009447 7000009447 Scopus Author ID 47661817400 47661817400 著者名 Shinzawa, Maki
	NRID 1000010362253 1000010362253 著者名 Maruyama, Shoichi
	著者名 Sakaguchi, Mika
	NRID 1000010378086 1000010378086 著者名 Hayashi, Hiroki
	NRID 1000080441658 1000080441658 著者名 Kaida, Yusuke
	NRID 1000000463969 1000000463969 著者名 Goto, Shin
	著者名 Tsukamoto, Tatsuo
	NRID 1000070431707 1000070431707 著者名 Maeshima, Akito
	NRID 1000010407398 1000010407398 著者名 Ikeda, Yoichiro
	NRID 1000060377421 1000060377421 著者名 Sakai, Norihiko
	著者名 Sawa, Naoki
	NRID 1000050432125 1000050432125 著者名 Furuichi, Kengo
	NRID 1000090312850 1000090312850 著者名 Yamagata, Kunihiro
	NRID 1000090447409 1000090447409 著者名 Wada, Takehiko
	NRID 1000070361491 1000070361491 著者名 Shibagaki, Yugo
	NRID 1000070292597 1000070292597 著者名 Hiromura, Keiju
内容	Isaka Y., Sakaguchi Y., Shinzawa M., et al. Rituximab for Relapsing Nephrotic Syndrome in Adults: A Randomized Clinical Trial. JAMA , (2025); https://doi.org/10.1001/jama.2025.19316.
抄録	Importance: The effects of rituximab on relapse of nephrotic syndrome in patients with adult-onset frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS) remain uncertain. Objective: To evaluate the effects of rituximab for patients with FRNS or SDNS. Design, Setting, and Participants: Multicenter, double-blind, randomized, placebo-controlled trial conducted at 13 centers in Japan. Adults with FRNS or SDNS who had urine protein of less than 0.3 g/gCr were enrolled between September 1, 2020, and June 28, 2022. Final follow-up occurred on March 15, 2024. Interventions: Patients were randomized to receive either intravenous rituximab, 375 mg/m2 (n = 36), or placebo (n = 36) at weeks 1, 2, and 25. Patients were followed up for 49 weeks. Main Outcomes and Measures: The primary outcome was the proportion of patients who were free of relapse of nephrotic syndrome at 49-week follow-up. Relapse was defined as urine protein of at least 1 g/gCr on 2 consecutive measurements. Results: Among 72 randomized participants (mean age, 47.9 years; 56.1% female), 66 (92%) received the study drug at least once and were included in analyses. The relapse-free rate at week 49 was 87.4% (95% CI, 69.8%-95.1%) in the rituximab group and 38.0% (95% CI, 22.1%-53.8%) in the placebo group (P <.001 by 1-sided log-rank test). One of 18 secondary outcomes was statistically significant (favoring rituximab). The median relapse-free time in the rituximab group was greater than 49.0 weeks and in the placebo group was 30.8 weeks. A stratified Cox model showed a hazard ratio for relapse of 0.16 (95% CI, 0.05-0.46; P <.001) in the rituximab group compared with the placebo group. The most common adverse effect was infusion reaction (13 [40.6%] in the rituximab group and 1 [2.9%] in the placebo group). Conclusions and Relevance: These results support use of rituximab to prevent relapse in adults with FRNS or SDNS.
出版者	American Medical Association
収録物名	JAMA
刊行年月	2025-11-05
言語	英語
ハンドルURL	https://hdl.handle.net/11094/103337
PISSN	00987484
eISSN	15383598
関連情報 (isVersionOf)	DOI (出版社版) https://doi.org/10.1001/jama.2025.19316
アクセス権	open access
権利情報	© 2025 American Medical Association.
出版タイプ	Accepted Manuscript
カテゴリ	学術雑誌論文 Journal Article

資源タイプ	学術雑誌論文
ローカル資源タイプ	学術雑誌論文
DCMI資源タイプ	text
DCTERMS.bibliographicCitation	JAMA. 2025
DC.title	Rituximab for Relapsing Nephrotic Syndrome in Adults: A Randomized Clinical Trial
DC.creator	Isaka, Yoshitaka
	Sakaguchi, Yusuke
	Shinzawa, Maki
	Maruyama, Shoichi
	Sakaguchi, Mika
	Hayashi, Hiroki
	Kaida, Yusuke
	Goto, Shin
	Tsukamoto, Tatsuo
	Maeshima, Akito
	Ikeda, Yoichiro
	Sakai, Norihiko
	Sawa, Naoki
	Furuichi, Kengo
	Yamagata, Kunihiro
	Wada, Takehiko
	Shibagaki, Yugo
	Hiromura, Keiju
DC.publisher	American Medical Association
DC.language' scheme='DCTERMS.RFC1766	英語
DC.type' scheme='DCTERMS.DCMIType	text
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2025-11-05
DC.identifier	https://doi.org/10.1001/jama.2025.19316
DC.description	Isaka Y., Sakaguchi Y., Shinzawa M., et al. Rituximab for Relapsing Nephrotic Syndrome in Adults: A Randomized Clinical Trial. JAMA , (2025); https://doi.org/10.1001/jama.2025.19316.
DCTERMS.abstract	Importance: The effects of rituximab on relapse of nephrotic syndrome in patients with adult-onset frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS) remain uncertain. Objective: To evaluate the effects of rituximab for patients with FRNS or SDNS. Design, Setting, and Participants: Multicenter, double-blind, randomized, placebo-controlled trial conducted at 13 centers in Japan. Adults with FRNS or SDNS who had urine protein of less than 0.3 g/gCr were enrolled between September 1, 2020, and June 28, 2022. Final follow-up occurred on March 15, 2024. Interventions: Patients were randomized to receive either intravenous rituximab, 375 mg/m2 (n = 36), or placebo (n = 36) at weeks 1, 2, and 25. Patients were followed up for 49 weeks. Main Outcomes and Measures: The primary outcome was the proportion of patients who were free of relapse of nephrotic syndrome at 49-week follow-up. Relapse was defined as urine protein of at least 1 g/gCr on 2 consecutive measurements. Results: Among 72 randomized participants (mean age, 47.9 years; 56.1% female), 66 (92%) received the study drug at least once and were included in analyses. The relapse-free rate at week 49 was 87.4% (95% CI, 69.8%-95.1%) in the rituximab group and 38.0% (95% CI, 22.1%-53.8%) in the placebo group (P <.001 by 1-sided log-rank test). One of 18 secondary outcomes was statistically significant (favoring rituximab). The median relapse-free time in the rituximab group was greater than 49.0 weeks and in the placebo group was 30.8 weeks. A stratified Cox model showed a hazard ratio for relapse of 0.16 (95% CI, 0.05-0.46; P <.001) in the rituximab group compared with the placebo group. The most common adverse effect was infusion reaction (13 [40.6%] in the rituximab group and 1 [2.9%] in the placebo group). Conclusions and Relevance: These results support use of rituximab to prevent relapse in adults with FRNS or SDNS.
DC.rights	© 2025 American Medical Association.
DC.format	103337
citation_title	Rituximab for Relapsing Nephrotic Syndrome in Adults: A Randomized Clinical Trial
citation_author	Isaka, Yoshitaka
	Sakaguchi, Yusuke
	Shinzawa, Maki
	Maruyama, Shoichi
	Sakaguchi, Mika
	Hayashi, Hiroki
	Kaida, Yusuke
	Goto, Shin
	Tsukamoto, Tatsuo
	Maeshima, Akito
	Ikeda, Yoichiro
	Sakai, Norihiko
	Sawa, Naoki
	Furuichi, Kengo
	Yamagata, Kunihiro
	Wada, Takehiko
	Shibagaki, Yugo
	Hiromura, Keiju
citation_publisher	American Medical Association
citation_language	英語
citation_date	2025-11-05
citation_journal_title	JAMA
citation_doi	https://doi.org/10.1001/jama.2025.19316
citation_public_url	https://hdl.handle.net/11094/103337

Rituximab for Relapsing Nephrotic Syndrome in Adults: A Randomized Clinical Trial

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