Single dose of rituximab for refractory steroid-dependent nephrotic syndrome in children

Koichi Kamei, Shuichi Ito, Kandai Nozu, Shuichiro Fujinaga, Makiko Nakayama, Mayumi Sako, Mari Saito, Maki Yoneko, Kazumoto Iijima

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    Abstract

    We conducted a multicenter prospective trial to evaluate the efficacy, safety and pharmacokinetics of a single dose of rituximab (375 mg/m2 body surface area) for the treatment of children with refractory steroid-dependent nephrotic syndrome (SDNS). All patients (n=12) were able to discontinue steroids at a median of 74 days after treatment. The frequency of relapses per 6 months was significantly reduced and the steroid-free period per 6 months was significantly increased after treatment compared with those before treatment. The condition in nine of the patients (75%) relapsed at a median of 129 days after treatment, and seven patients were given additional rituximab due to steroid dependency. Most of the relapses developed simultaneously with recovery of B-cells. However, three patients (25%) did not have a relapse with B-cell recovery and the disease was kept in remission for more than 1 year. None of the patients developed life-threatening adverse events. This is the first report of a prospective study of a single dose of rituximab for refractory SDNS. Treatment with a single dose of rituximab may be effective for refractory SDNS, but its efficacy to prevent relapses was transient in most of the patients.

    Original languageEnglish
    Pages (from-to)1321-1328
    Number of pages8
    JournalPediatric Nephrology
    Volume24
    Issue number7
    DOIs
    Publication statusPublished - 2009

    Keywords

    • Children
    • Clinical trial
    • Pharmacokinetics
    • Refractory steroid-dependent nephrotic syndrome
    • Rituximab

    ASJC Scopus subject areas

    • Pediatrics, Perinatology, and Child Health
    • Nephrology

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  • Cite this

    Kamei, K., Ito, S., Nozu, K., Fujinaga, S., Nakayama, M., Sako, M., Saito, M., Yoneko, M., & Iijima, K. (2009). Single dose of rituximab for refractory steroid-dependent nephrotic syndrome in children. Pediatric Nephrology, 24(7), 1321-1328. https://doi.org/10.1007/s00467-009-1191-0