| 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
Sako, Mayumi
Nakanishi, Koichi
Ishikura, Kenji
Ito, Shuichi
Nakamura, Hidefumi
Oba, Saito Mari
Nozu, Kandai
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 |
| 権利情報 |
|
|
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 |
| 主題 |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
rituximab |
| 主題 |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
frequently-relapsing nephrotic syndrome |
| 主題 |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
steroid-dependent nephrotic syndrome |
| 主題 |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
steroid-sensitive nephrotic syndrome |
| 主題 |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
multicenter |
| 主題 |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
double-blind |
| 主題 |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
randomized |
| 主題 |
|
|
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 |
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|
内容記述タイプ |
Other |
|
内容記述 |
論文 |
| 出版者 |
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出版者 |
Springer Nature |
|
言語 |
en |
| 言語 |
|
|
言語 |
eng |
| 資源タイプ |
|
|
資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
|
資源タイプ |
journal article |
| 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 |
|
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|
識別子タイプ |
DOI |
|
|
関連識別子 |
https://doi.org/10.1186/s12882-018-1099-7 |
| 関連情報 |
|
|
|
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 |
|
|
収録物名 |
BMC Nephrology |
|
言語 |
en |
| 書誌情報 |
巻 19,
発行日 2018-11-01
|
s12882-018-1099-7.pdf
