Randomized Controlled Trial to Compare the Efficacy of Low-dose Daily vs Alternate-day Prednisolone in Children With Steroid Dependent and Frequently Relapsing Nephrotic Syndrome Daily vs Alternate-day Prednisolone in Nephrotic Syndrome
Journal of Pediatric Nephrology,
Vol. 11 No. 3 (2023),
16 October 2024
https://doi.org/10.22037/jpn.v11i3.44033
Abstract
Background and Aim: Tapering alternate-day doses of corticosteroid forms the cornerstone
of the management of steroid-dependent nephrotic syndrome (SDNS) and frequently relapsing
nephrotic syndrome nephrotic syndrome (FRNS). This study compares the reduction of
relapses over a one-year follow-up, using equivalent steroid doses given as either daily or
alternate-day therapy.
Methods: This was an open-label, randomized controlled trial. The participants were children
with SDNS or FRNS, aged 2-10 years. After remission, steroid doses were tapered until a
threshold below 0.75 mg/kg/day. Then, subjects were randomized to one of two arms as
follows: Daily prednisolone at 0.15-0.30 mg/kg/day (intervention arm) or alternate-day dose
of 0.5-0.75 mg/kg (control arm). Both groups were compared after 12 months for a reduction
in relapse frequency. Secondary outcome measures included time to first relapse, proportion
of relapse-free patients, mean steroid dose used, infection episodes, need for alternative
medications, and side effects of corticosteroids.
Results: Median (interquartile range [IQR]) changes in relapse frequency did not differ
between the groups, 0 (IQR: -1.0, 0.25) vs 0 (IQR: 0.0, 1.0) in intervention and control groups,
respectively (P=0.46). The mean percentage change in relapse frequency was -18.1±42.4%
(negative denotes decreased) in the intervention group and 6.0±26.9% in the control group
(P=0.05). The median relapse frequencies during the trial period were 3 (IQR: 2, 3) and 3
(IQR: 3, 4) in the intervention group and control groups, respectively (P=0.021). At study
completion, prednisolone dose was lower in the intervention group, 0.33±0.12 vs 0.40±0.05
(P=0.02). Both groups did not differ by other secondary outcome variables.
Conclusion: In patients with SDNS and FRNS, daily low dose (0.15-0.30 mg/kg/day)
administration of prednisolone is not superior to conventional alternate-day dosing.
- Glucocorticoids
- Minimal change disease
- Nephrotic syndrome
- Stunting
How to Cite
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