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Kidney Week

Abstract: TH-PO1202

Rituximab for Adult-Onset Frequently Relapsing or Steroid-Dependent Nephrotic Syndrome: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

  • Isaka, Yoshitaka, Osaka Daigaku, Suita, Osaka, Japan
  • Maruyama, Shoichi, Nagoya Daigaku, Nagoya, Aichi, Japan
  • Sakaguchi, Mika, Kinki Daigaku, Higashiosaka, Osaka, Japan
  • Hayashi, Hiroki, Fujita Ika Daigaku, Toyoake, Aichi, Japan
  • Kaida, Yusuke, Kurume Daigaku, Kurume, Fukuoka, Japan
  • Goto, Shin, Niigata Daigaku, Niigata, Niigata, Japan
  • Tsukamoto, Tatsuo, Igaku Kenkyujo Kitano Byoin, Osaka, Osaka, Japan
  • Maeshima, Akito, Saitama Ika Daigaku Sogo Iryo Center, Kawagoe, Saitama, Japan
  • Ikeda, Yoichiro, Tokyo Daigaku, Bunkyo-ku, Tokyo, Japan
  • Sakai, Norihiko, Kanazawa Daigaku, Kanazawa, Ishikawa, Japan
  • Sawa, Naoki, Toranomon Byoin, Minato-ku, Tokyo, Japan
  • Furuichi, Kengo, Kanazawa Ika Daigaku, Kahoku-gun, Ishikawa, Japan
  • Yamagata, Kunihiro, Tsukuba Daigaku, Tsukuba, Ibaraki, Japan
  • Sakaguchi, Yusuke, Osaka Daigaku, Suita, Osaka, Japan
  • Shinzawa, Maki, Osaka Daigaku, Suita, Osaka, Japan
  • Wada, Takehiko, Toranomon Byoin, Minato-ku, Tokyo, Japan
  • Shibagaki, Yugo, Sei Marianna Ika Daigaku, Kawasaki, Kanagawa, Japan
  • Hiromura, Keiju, Gunma Daigaku, Maebashi, Gunma, Japan

Group or Team Name

  • A-TEAM.
Background

Among adult-onset nephrotic syndromes, side effects of long-term steroid use are problematic in patients with frequently relapsing nephrotic syndrome (FRNS) and patients with steroid-dependent nephrotic syndrome (SDNS). We investigated the efficacy and safety of rituximab on FRNS or SDNS patients.

Methods

We performed a multicenter, double-blind, randomized, placebo-controlled trial at 13 centers in Japan. Adult-onset FRNS or SDNS patients with urinary protein <0.3 g/gCr on at least two urine protein determinations after initiation of steroid therapy for the most recent relapse were enrolled. Patients received rituximab (375 mg/m2) or placebo twice a week apart, and at 25 weeks. The dose of steroids was reduced and discontinued every 4 weeks in principle. Subjects who relapsed (urinary protein 1 g/g Cr or higher) within 49 weeks from the start date of the investigational drug could receive rituximab treatment once they were in remission after treatment with steroids. The primary endpoint was the relapse-free period. Safety endpoints were frequency and severity of adverse events. Patients who received their assigned intervention were included in analyses. This trial is registered with the University Hospital Medical Information Network clinical trials registry, number UMIN000041475.

Results

66 patients received the assigned intervention (32 were given rituximab and 34 placebo). The median relapse-free period was significantly longer in the rituximab group (not reached, 95% CI -/-) than in the placebo group(29.8 week, 20.1/-; hazard ratio: 0.16, 0.05-0.46; p=0.0008). The recurrence-free rate at 49 weeks was 86.5% in the rituximab group and 37.2% in the placebo group (p<0.0001). The recurrence-free rate at 49 weeks for patients who entered the treatment phase after relapse was 66.7% (2 of 3 patients) in the rituximab group and 100% (20 of 20 patients) in the placebo group. Four patients (12.5%) in the rituximab group and 2 (5.9%) in the placebo group had at least one serious adverse event.

Conclusion

Rituximab is an effective and safe treatment for the prevention of adult-onset FRNS and SDNS relapse.

Funding

  • Commercial Support – Zenyaku Kogyo Co., Ltd.