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

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

doi:10.1038/s41598-025-19214-0

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

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

Abstract

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/m2, 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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Article Details

Journal Scientific Reports

Volume / Issue Vol. 15, Issue 1

Published October 10, 2025

DOI 10.1038/s41598-025-19214-0

ISSN 2045-2322

Publisher Nature Portfolio

Journal Info

Scientific Reports

Nature Portfolio

ISSN: 2045-2322 Open Access Life Sciences

Authors (53)

K

Kazumoto Iijima

T

Tomoko Horinouchi

T

Tomoyuki Sakai

T

Tomohiko Yamamura

R

Riku Hamada

Y

Yasufumi Ohtsuka

S

Seiji Tanaka

K

Koichi Kamei

R

Ryojiro Tanaka

Y

Yuji Kano

T

Takuo Kubota

Y

Yuko Shima

T

Tamaki Morohashi

A

Aya Inaba

S

Shuichiro Fujinaga

M

Masafumi Oka

H

Hiroshi Kaito

A

Akihide Konishi

C

China Nagano

K

Koichi Nakanishi

K

Kenji Ishikura

S

Shuichi Ito

H

Hidefumi Nakamura

G

Gian Marco Ghiggeri

R

Rintaro Mori

T

Takashi Omori

N

Nana Sakakibara

A

Atsushi Kondo

H

Hideaki Kitakado

C

Chika Ueda

T

Toshihiro Sawai

K

Kazuna Yamamoto

S

Satoko Ichioka

T

Toshiki Masuda

H

Hiroshi Hataya

R

Ryoko Harada

C

Chikako Terano

N

Naoaki Mikami

T

Tomohiro Inoguchi

K

Kouki Tomari

K

Keiji Akamine

S

Shoichiro Shirane

T

Taishi Nada

T

Toru Kanamori

C

Chikako Kamae

Y

Yosuke Inaguma

Y

Yuhi Takagi

T

Toru Uchimura

K

Kandai Nozu

M

Mayumi Sako

M

Motoshi Hattori

N

Nao Tsuchida

M

Mari Oba

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

Abstract

Article Details

Journal Info

Authors (53)

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