Long-term outcome of childhood-onset complicated nephrotic syndrome after a multicenter, double-blind, randomized, placebo-controlled trial of rituximab View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2017-06-29

AUTHORS

Koichi Kamei, Kenji Ishikura, Mayumi Sako, Kunihiko Aya, Ryojiro Tanaka, Kandai Nozu, Hiroshi Kaito, Koichi Nakanishi, Yoshiyuki Ohtomo, Kenichiro Miura, Shori Takahashi, Tetsuji Morimoto, Wataru Kubota, Shuichi Ito, Hidefumi Nakamura, Kazumoto Iijima, on behalf of the Rituximab for Childhood-Onset Refractory Nephrotic Syndrome (RCRNS) Study Group

ABSTRACT

BackgroundAlthough rituximab effectively prevents relapses of complicated frequently relapsing nephrotic syndrome (FRNS) and steroid-dependent nephrotic syndrome (SDNS), data of long-term outcomes and safety are limited.MethodsFifty-one patients (age, 3–38 years) with childhood-onset complicated FRNS or SDNS, who received rituximab in investigator-initiated multicenter prospective trials were enrolled. Rituximab was administered at 375 mg/m2 once weekly for 4 weeks, and immunosuppressive agents were discontinued according to the study protocol. We investigated relapses, re-administration of immunosuppressive agents, additional rituximab treatment, body height, renal function, and late adverse events during the observation period.ResultsForty-eight patients (94%) developed relapses during the observation period (median, 59 months) and the 50% relapse-free survival was 261 days. Thirty patients (59%) developed SDNS, 44 (86%) required re-administration of immunosuppressive agents, and 22 (43%) received additional rituximab treatment. All patients who were receiving immunosuppressive agents at rituximab treatment required either immunosuppressive agents or additional rituximab treatment. On the contrary, 5 of the 13 patients without immunosuppressive agents at rituximab treatment required neither immunosuppressive agents nor additional rituximab treatment and 3 of them did not develop relapse during observation period. Growth failure due to steroid toxicity did not progress and none of the patients developed chronic renal insufficiency. None of the patients suffered from rituximab-related late adverse events.ConclusionsAs most patients suffer from relapses after B-cell recovery, long-term immunosuppressive agents or additional rituximab treatment is necessary. However, some patients who can discontinue immunosuppressive agents before rituximab treatment may achieve long-term remission after rituximab treatment without immunosuppressive agents. More... »

PAGES

2071-2078

Journal

TITLE

Pediatric Nephrology

ISSUE

11

VOLUME

32

Author Affiliations

  • Division of Nephrology and Rheumatology, National Center for Child Health and Development, 2-10-1, Okura, Setagaya-ku, 157-8535, Tokyo, Japan
  • Division for Clinical Trials, Department of Clinical Research, Center for Clinical Research and Development, National Center for Child Health and Development, 2-10-1, Okura, Setagaya-ku, 157-8535, Tokyo, Japan
  • Department of Pediatrics, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, 710-8602, Okayama, Japan
  • Department of Nephrology, Hyogo Prefectural Kobe Children’s Hospital, 1-6-7, Minamimachi, Minatojima, Chuo-ku, 650-0047, Kobe, Hyogo, Japan
  • Department of Pediatrics, Kobe University Graduate School of Medicine, 7-5-2, Kusunoki-cho, Chuo-ku, 650-0017, Kobe, Hyogo, Japan
  • Department of Child Health and Welfare (Pediatrics), Graduate School of Medicine, University of the Ryukyus, 207, Azauehara, Nishihara-cho, Nakagami-gun, 903-0215, Okinawa, Japan
  • Department of Pediatrics, Juntendo University Nerima Hospital, 3-1-10, Takanodai, Nerima-ku, 177-8521, Tokyo, Japan
  • Department of Pediatric Nephrology, Tokyo Women’s Medical University, School of Medicine, 8-1, Kawada-cho, Shinjuku-ku, 162-8666, Tokyo, Japan
  • Department of Pediatrics, Nihon University Itabashi Hospital, 30-1, Oyaguchikamimachi, Itabashi-ku, 173-8610, Tokyo, Japan
  • Division of Pediatrics, Tohoku Medical and Pharmaceutical University Hospital, 1-12-1, Fukumuro, Miyagino-ku, 983-8512, Sendai, Miyagi, Japan
  • Department of Nephrology, Tokyo Metropolitan Children’s Medical Center, 2-8-29, Musashidai, Fuchu, 183-8561, Tokyo, Japan
  • Department of Pediatrics, Graduate School of Medicine, Yokohama City University, 3-9, Fukuura, Kanazawa-ku, 236-0004, Yokohama, Kanagawa, Japan
  • Department of Development Strategy, Center for Clinical Research and Development, National Center for Child Health and Development, 2-10-1, Okura, Setagaya-ku, 157-8535, Tokyo, Japan
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s00467-017-3718-0

    DOI

    http://dx.doi.org/10.1007/s00467-017-3718-0

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1090306762

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/28664242


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