title: A multicenter randomized trial indicates initial prednisolone treatment for childhood nephrotic syndrome for two months is not inferior to six-month treatment.
abstract: In this multicenter, open-label, randomized controlled trial, we determined whether 2-month prednisolone therapy for steroid-sensitive nephrotic syndrome was inferior or not to 6-month therapy despite significantly less steroid exposure. The primary end point was time from start of initial treatment to start of frequently relapsing nephrotic syndrome. The pre-specified non-inferiority margin was a hazard ratio of 1.3 with one-sided significance of 5%. We randomly assigned 255 children with an initial episode of steroid-sensitive nephrotic syndrome to either 2 - or 6-month treatment of which 246 were eligible for final analysis. The total prednisolone exposure counted both initial and relapse prednisolone treatment administered over 24 months. Median follow-up in months was 36.7 in the 2-month and 38.2 in the 6-month treatment group. Time to frequent relaps was similar in both groups; however, the median was reached only in the 6-month group (799 days). The hazard ratio was 0.86 (90% confidence interval, 0.64-1.16) and met the non-inferior margin. Time to first relapse was also similar in both groups: median day 242 (2-month) and 243 (6-month). Frequency and severity of adverse events were similar in both groups. Most adverse events were transient and occurred during initial or relapse therapy. Thus, 2 months of initial prednisolone therapy for steroid-sensitive nephrotic syndrome, despite less prednisolone exposure, is not inferior to 6 months of initial therapy in terms of time to onset of frequently relapsing nephrotic syndrome.
authors: Department of Pediatrics, Wakayama Medical University, Wakayama City, Japan.
authors: Norishige
authors: N
authors: Yoshikawa
authors: Department of Pediatrics, Wakayama Medical University, Wakayama City, Japan.
authors: Koichi
authors: K
authors: Nakanishi
authors: Division for Clinical Trials, Clinical Research Center, National Center for Child Health and Development, Tokyo, Japan.
authors: Mayumi
authors: M
authors: Sako
authors: Department of Biostatistics and Epidemiology, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.
authors: Mari S
authors: MS
authors: Oba
authors: Department of Health Policy, National Center for Child Health and Development, Tokyo, Japan.
authors: Rintaro
authors: R
authors: Mori
authors: Department of Health Policy, National Center for Child Health and Development, Tokyo, Japan.
authors: Erika
authors: E
authors: Ota
authors: Department of Nephrology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.
authors: Kenji
authors: K
authors: Ishikura
authors: Department of Nephrology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.
authors: Hiroshi
authors: H
authors: Hataya
authors: Department of Nephrology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.
authors: Masataka
authors: M
authors: Honda
authors: Department of Nephrology and Rheumatology, National Center for Child Health and Development, Tokyo, Japan.
authors: Shuichi
authors: S
authors: Ito
authors: Department of Pediatrics, Wakayama Medical University, Wakayama City, Japan.
authors: Yuko
authors: Y
authors: Shima
authors: Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Japan.
authors: Hiroshi
authors: H
authors: Kaito
authors: Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Japan.
authors: Kandai
authors: K
authors: Nozu
authors: Division for Clinical Trials, Clinical Research Center, National Center for Child Health and Development, Tokyo, Japan.
authors: Hidefumi
authors: H
authors: Nakamura
authors: National Center for Child Health and Development, Tokyo, Japan.
authors: Takashi
authors: T
authors: Igarashi
authors: Department of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan.
authors: Yasuo
authors: Y
authors: Ohashi
authors: Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Japan.
authors: Kazumoto
authors: K
authors: Iijima
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007223:Infant; D008297:Male; D009404:Nephrotic Syndrome / Q000188:drug therapy*; D011239:Prednisolone / Q000008:administration & dosage*; D012008:Recurrence
chemical_list: D005938:Glucocorticoids; D011239:Prednisolone