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  1. 学術雑誌論文
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  1. 部局別インデックス
  2. 医学部

Study protocol : multicenter double-blind, randomized, placebo-controlled trial of rituximab for the treatment of childhood-onset early-stage uncomplicated frequently relapsing or steroid-dependent nephrotic syndrome (JSKDC10 trial)

http://hdl.handle.net/20.500.12000/45876
http://hdl.handle.net/20.500.12000/45876
deeb4aa0-607c-42a1-ae6c-5cc614222af9
名前 / ファイル ライセンス アクション
Nagano2019_Article_StudyProtocolMulticenterDouble.pdf Nagano2019_Article_StudyProtocolMulticenterDouble.pdf
Item type デフォルトアイテムタイプ(フル)(1)
公開日 2020-05-22
タイトル
タイトル Study protocol : multicenter double-blind, randomized, placebo-controlled trial of rituximab for the treatment of childhood-onset early-stage uncomplicated frequently relapsing or steroid-dependent nephrotic syndrome (JSKDC10 trial)
言語 en
作成者 Nagano, China

× Nagano, China

en Nagano, China

Sako, Mayumi

× Sako, Mayumi

en Sako, Mayumi

Kamei, Koichi

× Kamei, Koichi

en Kamei, Koichi

Ishikura, Kenji

× Ishikura, Kenji

en Ishikura, Kenji

Nakamura, Hidefumi

× Nakamura, Hidefumi

en Nakamura, Hidefumi

Nakanishi, Koichi

× Nakanishi, Koichi

en Nakanishi, Koichi

Omori, Takashi

× Omori, Takashi

en Omori, Takashi

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 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 Frequently relapsing nephrotic syndrome
言語 en
主題Scheme Other
主題 Steroid-sensitive nephrotic syndrome
言語 en
主題Scheme Other
主題 Rituximab
内容記述
内容記述タイプ Other
内容記述 Background: Eighty percent of children with idiopathic nephrotic syndrome respond well to steroid therapy, but up to 50% of patients with steroid-sensitive nephrotic syndrome exhibit frequently relapsing (FRNS) or steroid-dependent nephrotic syndrome (SDNS). Several studies identified the chimeric anti-CD20 monoclonal antibody rituximab as an effective treatment for patients with complicated FRNS/SDNS. Recent studies suggested that rituximab could also be a first-line treatment for early-stage uncomplicated FRNS/SDNS, although further studies are required to confirm its efficacy and safety. Methods/design: We are conducting a multicenter, double-blind, randomized placebo controlled trial to investigate the efficacy and safety of rituximab for the treatment of childhood-onset early-stage uncomplicated FRNS/SDNS. Patients will be allocated to receive two 375 mg/m(2) doses (maximum dose: 500 mg) of either rituximab or placebo. Investigators are permitted to request the disclosure of a subject's allocation code if he or she exhibits treatment failure. Additionally, if placebo-treated subjects display early relapse (a sign of treatment failure), they have the option to receive rituximab in an unblinded phase. The primary endpoint is relapse-free survival during the observation period. Discussion: The results will provide important data on the use of rituximab for patients with uncomplicated FRNS/SDNS. In the future, rituximab treatment will enable most patients with uncomplicated FRNS/SDNS to discontinue or reduce steroid therapy without relapse, and it is possible that rituximab could represent an immunosuppressive therapy for these diseases.
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/20.500.12000/45876
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/s12882-019-1470-3
関連識別子
識別子タイプ DOI
関連識別子 https://doi.org/10.1186/s12882-019-1470-3
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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