A Multi center, Double-Blind, Rando

A Multi center, Double-Blind, Randomized, Placebo-
Controlled Trial of Rituximab Therapy for Childhood-
Onset Complicated FRNS/SDNS
To evaluate the efficacy and safety of rituximab inchildhood onset complicated FRNS/SDNS,amulti center,double-blind,
randomized, placebo-controlled trial was carried out by the
Research Group of Childhood-onset Refractory Nephrotic
Syndrome (RCRNS) in Japan (RCRNS01) (Clinical Trials
Registry ID: UMIN000001405). At the same time, an open-
label, multicenter, pharmacokinetic trial (RCRNS-02)
(Clinical Trials Registry ID: UMIN000001406) was also
carried out. These two trials were investigator-initiated
clinical trials, which sought to gain approval from the Min-
istryofHealth,LabourandWelfare,Japantomakerituximab
available for patients with childhood-onset complicated
FRNS/SDNS. These trials were supported by a Health and
Labor Sciences Research Grant for the Large Scale Clinical
Trial Network Project (CCT-B-2001). The study design of
RCRNS01 is shown in Fig. 1. The protocol for RCRNS01 is
available at http://www.med.kobe-u.ac.jp/pediat/pdf/rcrn01.
pdf.Whenpatientsdevelopedrelapseofnephroticsyndrome,

Hasil (Bahasa Indonesia) 2:

Sebuah pusat multi, Double-Blind, Acak, plasebo
terkontrol Pengadilan Rituximab Terapi untuk masa kecil
Onset Complicated SNKS / SDN
Untuk mengevaluasi efikasi dan keamanan rituximab inchildhood onset rumit SNKS / SDN, pusat amulti, double-blind,
acak, plasebo percobaan -controlled dilakukan oleh
Research Group of Childhood-onset tahan panas Nefrotik
Syndrome (RCRNS) di Jepang (RCRNS01) (Clinical Trials
Registry ID: UMIN000001405). Pada saat yang sama, sebuah terbuka-
label, multicenter, percobaan farmakokinetik (RCRNS-02)
(Clinical Trials Registry ID: UMIN000001406) juga
dilakukan. Kedua percobaan yang penyidik-dimulai
uji klinis, yang berusaha untuk mendapatkan persetujuan dari kementerian
istryofHealth, LabourandWelfare, Japantomakerituximab
tersedia untuk pasien dengan masa-onset rumit
SNKS / SDN. Percobaan ini didukung oleh Kesehatan dan
Ilmu Tenaga Kerja Penelitian Hibah Skala Besar Clinical
Percobaan Proyek Jaringan (CCT-B-2001). Desain penelitian dari
RCRNS01 ditunjukkan pada Gambar. 1. Protokol untuk RCRNS01 adalah
tersedia di http://www.med.kobe-u.ac.jp/pediat/pdf/rcrn01.
pdf.Whenpatientsdevelopedrelapseofnephroticsyndrome,