• Bmc Nephrol · Sep 2018

    Randomized Controlled Trial Multicenter Study

    Study protocol: high-dose mizoribine with prednisolone therapy in short-term relapsing steroid-sensitive nephrotic syndrome to prevent frequent relapse (JSKDC05 trial).

    • Taketsugu Hama, Koichi Nakanishi, Kenji Ishikura, Shuichi Ito, Hidefumi Nakamura, Mayumi Sako, Mari Saito-Oba, Kandai Nozu, Yuko Shima, Kazumoto Iijima, Norishige Yoshikawa, and Japanese Study Group of Kidney Disease in Children (JSKDC).
    • Department of Pediatrics, Wakayama Medical University, Wakayama, Japan.
    • Bmc Nephrol. 2018 Sep 10; 19 (1): 223.

    BackgroundEighty 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/DesignWe 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.DiscussionThe 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.Trial RegistrationUMIN000005103 , (Prospectively registered 1st March 2011).

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