Rituximab-induced long-term remission in childhood-onset, uncomplicated, frequently relapsing or steroid-dependent nephrotic syndrome: a randomized, placebo-controlled trial and a follow-up study

Rituximab maintains remission of complicated frequently relapsing or steroid-dependent nephrotic syndrome (FRNS/SDNS) by depleting peripheral B cells, but most patients eventually experience relapses after B cell recovery. We performed a multicenter, double-blind, randomized, placebo-controlled trial to assess rituximab's efficacy and safety for childhood-onset uncomplicated FRNS/SDNS (without prior treatment with glucocorticoid-sparing immunosuppressive agents) with a follow-up study to assess rituximab's long-term effect after B cell recovery. Patients were randomly assigned to receive either rituximab (375 mg/m<sup>2</sup>, maximum 500 mg, once weekly for 2 weeks) or placebo. The primary endpoint was the relapse-free period. Of 43 randomized patients, 40 received the intervention (18 rituximab, 22 placebo). The relapse-free period during the 1-year trial was significantly longer in the rituximab vs. placebo groups (median: 285 vs. 81 days; p < 0.001). Infusion reactions were more frequent in the rituximab group (p < 0.001), with no difference in adverse events incidence between the groups. Interestingly, the follow-up study demonstrated markedly higher 3-year cumulative relapse-free survival probability without further treatments in the rituximab vs. placebo groups (38% vs. 9%). A mini-systematic review with meta-analyses supported the findings. Rituximab is effective and well-tolerated, potentially leading to long-term remission with substantially high rates after B cell recovery for childhood-onset uncomplicated FRNS/SDNS.Trial registration JSKDC10, Clinical Trials Registry ID: jRCT1091220380; JSKDC10 follow-up study, Clinical Trials Registry ID: jRCT1050230024.

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Journal
Scientific Reports
Published
2025-10-10
DOI
https://doi.org/10.1038/s41598-025-19214-0
Citations
1
Primary Topic
Renal Diseases and Glomerulopathies
Type
article
Field-Weighted Citation Impact
1.43
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article

Rituximab-induced long-term remission in childhood-onset, uncomplicated, frequently relapsing or steroid-dependent nephrotic syndrome: a randomized, placebo-controlled trial and a follow-up study

Hideaki Kitakado, Nao Tsuchida, Atsushi Kondo, Kandai Nozu et al.
1 citations
Scientific Reports
Renal Diseases and Glomerulopathies
1.43
article

Rituximab-induced long-term remission in childhood-onset, uncomplicated, frequently relapsing or steroid-dependent nephrotic syndrome: a randomized, placebo-controlled trial and a follow-up study

Hideaki Kitakado, Nao Tsuchida, Atsushi Kondo, Kandai Nozu, Taishi Nada, Toru Uchimura, Hidefumi Nakamura, Toshihiro Sawai, Tamaki Morohashi, China Nagano, Toshiki Masuda, Ryojiro Tanaka, Koichi Nakanishi, Rintaro Mori, Chika Ueda, Kazumoto Iijima, Gian Marco Ghiggeri, Tomoyuki Sakai, Kouki Tomari, Tomohiro Inoguchi, Takuo Kubota, Akihide Konishi, Yuko Shima, Toru Kanamori, Keiji Akamine, Nana Sakakibara, Yasufumi Ohtsuka, Masafumi Oka, Aya Inaba, Yosuke Inaguma, Naoaki Mikami, Chikako Terano, Shuichiro Fujinaga, Chikako Kamae, Satoko Ichioka, Mayumi Sako, Seiji Tanaka, Yuhi Takagi, Shoichiro Shirane, Hiroshi Hataya, Shuichi Ito, Kenji Ishikura, Riku Hamada, H. Kaito, Tomoko Horinouchi, Mari S. Oba, Koichi Kamei, Kazuna Yamamoto, Tomohiko Yamamura, Takashi Omori, Ryoko Harada, Motoshi Hattori, Yuji Kano
article en
1 citations

Abstract

Rituximab maintains remission of complicated frequently relapsing or steroid-dependent nephrotic syndrome (FRNS/SDNS) by depleting peripheral B cells, but most patients eventually experience relapses after B cell recovery. We performed a multicenter, double-blind, randomized, placebo-controlled trial to assess rituximab's efficacy and safety for childhood-onset uncomplicated FRNS/SDNS (without prior treatment with glucocorticoid-sparing immunosuppressive agents) with a follow-up study to assess rituximab's long-term effect after B cell recovery. Patients were randomly assigned to receive either rituximab (375 mg/m<sup>2</sup>, maximum 500 mg, once weekly for 2 weeks) or placebo. The primary endpoint was the relapse-free period. Of 43 randomized patients, 40 received the intervention (18 rituximab, 22 placebo). The relapse-free period during the 1-year trial was significantly longer in the rituximab vs. placebo groups (median: 285 vs. 81 days; p < 0.001). Infusion reactions were more frequent in the rituximab group (p < 0.001), with no difference in adverse events incidence between the groups. Interestingly, the follow-up study demonstrated markedly higher 3-year cumulative relapse-free survival probability without further treatments in the rituximab vs. placebo groups (38% vs. 9%). A mini-systematic review with meta-analyses supported the findings. Rituximab is effective and well-tolerated, potentially leading to long-term remission with substantially high rates after B cell recovery for childhood-onset uncomplicated FRNS/SDNS.Trial registration JSKDC10, Clinical Trials Registry ID: jRCT1091220380; JSKDC10 follow-up study, Clinical Trials Registry ID: jRCT1050230024.

Scientific ReportsVol. 15(1)
Nihon University (JP), Kurume University (JP), Osaka Gakuin University (JP), Shiga University of Medical Science (JP), Saga University (JP), Wakayama Medical University (JP), Kyoto University (JP), Istituto Giannina Gaslini (IT), University of the Ryukyus (JP), Kobe University Hospital (JP), Saitama Children's Medical Center (JP), National Center of Neurology and Psychiatry (JP), Kobe Children's Hospital (JP), National Center For Child Health and Development (JP), Tokyo Women's Medical University (JP), National Hospital Organization (JP), Tokyo Metropolitan Children's Medical Center (JP), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Kitasato University (JP), Kobe University (JP), Dokkyo Medical University (JP), Yokohama City University (JP), The University of Osaka (JP)
Openalex Percentile: Top 15%
Renal Diseases and Glomerulopathies
1.43
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