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Title :Study protocol: high-dose mizoribine with prednisolone therapy in short-term relapsing steroid-sensitive nephrotic syndrome to prevent frequent relapse (JSKDC05 trial)
Authors :Hama, Taketsugu
Nakanishi, Koichi
Ishikura, Kenji
Ito, Shuichi
Nakamura, Hidefumi
Sako, Mayumi
Saito-Oba, Mari
Nozu, Kandai
Shima, Yuko
Iijima, Kazumoto
Yoshikawa, Norishige
Issue Date :10-Sep-2018
Abstract :Background: Eighty percent of children with steroid-sensitive nephrotic syndrome (SSNS) relapse within 2 years and 40-50% patients show frequently-relapsing nephrotic syndrome (FRNS). Patients showing a relapse within 6 months after initial remission are at high risk of FRNS. Since frequent prednisolone treatment for FRNS induces severe prednisolone side effects, development of a treatment to prevent patients from shifting to FRNS is desirable. Mizoribine is an immunosuppressive drug with fewer side effects than prednisolone. Recent studies reported the efficacy of high-dose mizoribine in children with FRNS. Methods/design: We conduct a multicenter, open, randomized controlled trial to investigate the efficacy and safety of standard prednisolone plus high-dose mizoribine therapy in children with SSNS showing a relapse within 6 months after an initial remission. Patients are allocated to either standard prednisolone alone treatment group, or standard prednisolone plus high-dose mizoribine group. For the former group, mizoribine is administered at a dose of 10 mg/kg/day once daily and continued for 2 years. The primary endpoint is the duration to frequent relapse. Discussion: The results provide important data on use of high-dose mizoribine to prevent SSNS patients from shifting to FRNS. Since blood concentrations of mizoribine have not been investigated in detail until now, there is a possibility that mizoribine is underestimated in favor of other immunosuppressive drugs. In future, high-dose mizoribine therapy may lead to prevention of relapse in children at high risk of FRNS, and to decreased total dose of prednisolone.
URL :https://doi.org/10.1186/s12882-018-1033-z
Type Local :雑誌掲載論文
ISSN :1471-2369
Publisher :Springer Nature
URI :http://hdl.handle.net/20.500.12000/45852
Citation :BMC Nephrology Vol.19
Appears in Collections:Peer-reviewed Journal Articles (Faculty of Medicine)

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