A multicenter randomized trial indicates initial prednisolone treatment for childhood nephrotic syndrome for two months is not inferior to six-month treatment

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...

Full description

Saved in:
Bibliographic Details
Published in:Kidney international 2015-01, Vol.87 (1), p.225-232
Main Authors: Yoshikawa, Norishige, Nakanishi, Koichi, Sako, Mayumi, Oba, Mari S., Mori, Rintaro, Ota, Erika, Ishikura, Kenji, Hataya, Hiroshi, Honda, Masataka, Ito, Shuichi, Shima, Yuko, Kaito, Hiroshi, Nozu, Kandai, Nakamura, Hidefumi, Igarashi, Takashi, Ohashi, Yasuo, Iijima, Kazumoto
Format: Article
Language:English
Subjects:
Adolescent
Child
Child, Preschool
Clinical Trial
Female
Glucocorticoids - administration & dosage
Humans
Infant
initial treatment
Male
nephrotic syndrome
Nephrotic Syndrome - drug therapy
pediatric nephrology
Prednisolone - administration & dosage
randomized controlled trial
Recurrence
steroid
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:0085-2538
1523-1755
DOI:10.1038/ki.2014.260