Format

Send to

Choose Destination
Kidney Int. 2015 Jan;87(1):225-32. doi: 10.1038/ki.2014.260. Epub 2014 Jul 23.

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

Author information

1
Department of Pediatrics, Wakayama Medical University, Wakayama City, Japan.
2
Division for Clinical Trials, Clinical Research Center, National Center for Child Health and Development, Tokyo, Japan.
3
Department of Biostatistics and Epidemiology, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.
4
Department of Health Policy, National Center for Child Health and Development, Tokyo, Japan.
5
Department of Nephrology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.
6
Department of Nephrology and Rheumatology, National Center for Child Health and Development, Tokyo, Japan.
7
Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Japan.
8
National Center for Child Health and Development, Tokyo, Japan.
9
Department of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan.

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.

PMID:
25054775
PMCID:
PMC4284810
DOI:
10.1038/ki.2014.260
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Elsevier Science Icon for PubMed Central
Loading ...
Support Center