Abstract: FR-OR62
Randomized Controlled Trial Comparing 3- vs. 6-Months Initial Prednisone Therapy in Young (<4-Year-Old) Children with Nephrotic Syndrome
Session Information
- High-Impact Clinical Trials
November 05, 2021 | Location: Live-Stream, Virtual Only
Abstract Time: 10:45 AM - 11:00 AM
Category: Pediatric Nephrology
- 1700 Pediatric Nephrology
Authors
- Sinha, Aditi, All India Institute of Medical Sciences, New Delhi, Delhi, India
- Hari, Pankaj, All India Institute of Medical Sciences, New Delhi, Delhi, India
- Bagga, Arvind, All India Institute of Medical Sciences, New Delhi, Delhi, India
Group or Team Name
- Nephrotic Syndrome Study Group
Background
While recent RCTs suggest no role for prolonged (>2-3 months) initial corticosteroid therapy in NS, subgroup analysis in 2-studies suggests its association with reduced frequency of subsequent relapses in children <4-6 yr-old. This multicenter open-label trial examines the efficacy & safety of 3-months versus 6-months prednisone therapy during the first episode of NS in patients <4-yr-old [CTRI2015/06/005939; NCT03141970].
Methods
Following ethics approval & parental consent, 172 consecutive patients (1-4 yr-old) were enrolled at onset of idiopathic NS during 2015-19. After 6-wk daily & 6-wk alternate day (AD) initial prednisone therapy, they were randomized (1:1) to either tapering prednisone on AD for 12-wk or no therapy. Relapses were treated with prednisone 2 mg/kg/d till remission, then on AD for 4-wk. Outcomes, based on intention-to-treat analysis during 2-yr follow up, include the proportion of patients with relapse or frequent relapses, time to first relapse, cumulative steroid dose & adverse effects. Based on a prior RCT, at 80% power & α=0.05) 78 patients were required per group to show 30% higher sustained remission with 6-mo therapy.
Results
Baseline features in the groups were similar (Fig 1). Despite trends favoring 6-mo therapy, proportions of patients in sustained remission & frequent relapses at 1- & 2-yr, time to relapse (HR 0.75; 95%CI 0.53-1.06) or frequent relapses (HR 0.78; 0.52-1.18), and relapse rates were similar (Fig 1, 2). The rates of adverse events were similar.
Conclusion
Prolonged initial prednisolone therapy does not significantly alter the disease course in young children with NS.
Fig 1. Baseline characteristics & key outcome variables
Fig 2. Kaplan-Meier estimates of the time to (a) relapse, and (b) frequent relapses
Funding
- Government Support - Non-U.S.