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

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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.

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Acknowledgments

This study was supported by the Health and Labor Sciences Research Grant for the Large Scale Clinical Trial Network Project (to K.I.). The authors are grateful to Professor Shuki Mizutani, Department of Pediatrics and Developmental Biology, Tokyo Medical and Dental University, and the Zenyaku Corporation, for their helpful advice.

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Authors and Affiliations

  1. Department of Nephrology, National Center for Child Health and Development, Tokyo, Japan

    Koichi Kamei, Shuichi Ito, Makiko Nakayama, Mayumi Sako & Kazumoto Iijima

  2. Department of Pediatrics and Developmental Biology, Tokyo Medical and Dental University, Tokyo, Japan

    Koichi Kamei

  3. Department of Pediatrics, Yokohama City University Medial Center, Yokohama, Japan

    Shuichi Ito

  4. Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Japan

    Kandai Nozu

  5. Department of Nephrology, Saitama Children’s Medical Center, Saitama, Japan

    Shuichiro Fujinaga

  6. Biostatistics/Epidemiology and Preventive Health Sciences, School of Health Science and Nursing, University of Tokyo, Tokyo, Japan

    Mari Saito

  7. Division of Clinical Research, National Center for Child Health and Development, Tokyo, Japan

    Maki Yoneko

  8. Division of Child Health and Development, Department of Pediatrics, Kobe University Graduate School of Medicine, 5-1 Kusunoki-cho 7 chome, Chuo-ku, Kobe, 650-0017, Japan

    Kazumoto Iijima

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  1. Koichi Kamei
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  2. Shuichi Ito
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  3. Kandai Nozu
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  4. Shuichiro Fujinaga
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  5. Makiko Nakayama
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  6. Mayumi Sako
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  7. Mari Saito
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  8. Maki Yoneko
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  9. Kazumoto Iijima
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Correspondence to Kazumoto Iijima.

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Kamei, K., Ito, S., Nozu, K. et al. Single dose of rituximab for refractory steroid-dependent nephrotic syndrome in children. Pediatr Nephrol 24, 1321–1328 (2009). https://doi.org/10.1007/s00467-009-1191-0

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  • DOI: https://doi.org/10.1007/s00467-009-1191-0

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