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  1. 学術雑誌論文
  2. その他
  1. 部局別インデックス
  2. 医学部

Study protocol : mycophenolate mofetil as maintenance therapy after rituximab treatment for childhood-onset, complicated, frequently-relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome: a multicenter double-blind, randomized, placebo-controlled trial (JSKDC07)

http://hdl.handle.net/20.500.12000/45851
http://hdl.handle.net/20.500.12000/45851
2d96312a-f4e8-44d5-af0f-5e09c897a0ea
名前 / ファイル ライセンス アクション
s12882-018-1099-7.pdf s12882-018-1099-7.pdf
Item type デフォルトアイテムタイプ(フル)(1)
公開日 2020-05-21
タイトル
タイトル Study protocol : mycophenolate mofetil as maintenance therapy after rituximab treatment for childhood-onset, complicated, frequently-relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome: a multicenter double-blind, randomized, placebo-controlled trial (JSKDC07)
言語 en
作成者 Horinouchi, Tomoko

× Horinouchi, Tomoko

en Horinouchi, Tomoko

Sako, Mayumi

× Sako, Mayumi

en Sako, Mayumi

Nakanishi, Koichi

× Nakanishi, Koichi

en Nakanishi, Koichi

Ishikura, Kenji

× Ishikura, Kenji

en Ishikura, Kenji

Ito, Shuichi

× Ito, Shuichi

en Ito, Shuichi

Nakamura, Hidefumi

× Nakamura, Hidefumi

en Nakamura, Hidefumi

Oba, Saito Mari

× Oba, Saito Mari

en Oba, Saito Mari

Nozu, Kandai

× Nozu, Kandai

en Nozu, Kandai

Iijima, Kazumoto

× Iijima, Kazumoto

en Iijima, Kazumoto

アクセス権
アクセス権 open access
アクセス権URI http://purl.org/coar/access_right/c_abf2
権利情報
言語 en
権利情報 right:Creative Commons Attribution 4.0 International License
言語 en
権利情報Resource http://creativecommons.org/licenses/by/4.0/
権利情報 http://creativecommons.org/licenses/by/4.0/
主題
言語 en
主題Scheme Other
主題 Mycophenolate mofetil
言語 en
主題Scheme Other
主題 rituximab
言語 en
主題Scheme Other
主題 frequently-relapsing nephrotic syndrome
言語 en
主題Scheme Other
主題 steroid-dependent nephrotic syndrome
言語 en
主題Scheme Other
主題 steroid-sensitive nephrotic syndrome
言語 en
主題Scheme Other
主題 multicenter
言語 en
主題Scheme Other
主題 double-blind
言語 en
主題Scheme Other
主題 randomized
言語 en
主題Scheme Other
主題 placebo-controlled trial
内容記述
内容記述タイプ Other
内容記述 Background:Idiopathic nephrotic syndrome (INS) is the most common chronic glomerular disease in children. Approximately 80-90% of patients with childhood INS have steroid-sensitive nephrotic syndrome (SSNS), and can obtain remission with steroid therapy, while the remainder have steroid-resistant nephrotic syndrome (SRNS). Furthermore, approximately 50% of children with SSNS develop frequently-relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS). Children with FRNS/SDNS are usually treated with immunosuppressive agents such as cyclosporine, cyclophosphamide, or mizoribine in Japan. However, 10-20% of children receiving immunosuppressive agents still show frequent relapse and/or steroid dependence during or after treatment, which is defined as complicated FRNS/SDNS. Furthermore, 30% of SRNS patients who obtain remission after additional treatments such as cyclosporine also turn out to be complicated FRNS/SDNS. For such complicated FRNS/SDNS patients, rituximab (RTX) is currently used; however, recurrence after RTX treatment also remains an open issue. Because long-term use of existing immunosuppressive drugs has limitations, development of a novel treatment for maintenance therapy after RTX is desirable. Mycophenolate mofetil (MMF) is an immunosuppressive drug with fewer side effects than cyclosporine or cyclophosphamide. Importantly, recent studies have reported the efficacy of MMF in children with nephrotic syndrome.Methods:We conduct a multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of MMF after RTX therapy in children with complicated FRNS/SDNS. Patients are allocated to either RTX plus MMF treatment group, or RTX plus placebo treatment group. For the former group, MMF is administered at a dose of 1000-1200mg/m(2)/day (maximum 2g/day) twice daily for 17months after RTX treatment. The primary endpoint is time-to-treatment failure (development of frequent relapses, steroid dependence or steroid resistance).Discussion:The results will provide important data on the use of MMF as maintenance therapy after RTX to prevent complicated FRNS/SDNS patients from declining into treatment failure. In future, MMF in conjunction with RTX treatment may permit increased duration of remission in complicated' FRNS/SDNS cases.Trial registration:This trial was prospectively registered to UMIN Clinical Trials Registry on June 23, 2014 (UMIN Trial ID: UMIN000014347).
内容記述タイプ Other
内容記述 論文
出版者
言語 en
出版者 Springer Nature
言語
言語 eng
資源タイプ
資源タイプ journal article
資源タイプ識別子 http://purl.org/coar/resource_type/c_6501
出版タイプ
出版タイプ VoR
出版タイプResource http://purl.org/coar/version/c_970fb48d4fbd8a85
識別子
識別子 http://hdl.handle.net/20.500.12000/45851
識別子タイプ HDL
関連情報
関連識別子
識別子タイプ DOI
関連識別子 https://doi.org/10.1186/s12882-018-1099-7
関連識別子
識別子タイプ DOI
関連識別子 https://doi.org/10.1186/s12882-018-1099-7
収録物識別子
収録物識別子タイプ ISSN
収録物識別子 1471-2369
収録物名
言語 en
収録物名 BMC Nephrology
書誌情報
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