Body weight-based prednisolone versus body surface area-based prednisolone regimen for induction of remission in children with nephrotic syndrome: a randomized, open-label, equivalence clinical trial

Abstract

Background: Body surface area (BSA)-based prednisolone dosing for childhood nephrotic syndrome (NS) leads to higher cumulative prednisolone doses than body weight (BW)-based dosing. The clinical effects of this higher dosage have not been evaluated in prospective studies.

Methods: This parallel-group open-label randomized clinical trial enrolled 100 children with idiopathic NS, to receive BW-based (n = 50) or BSA-based (n = 50) prednisolone dosing by block randomization in a 1:1 ratio. The time taken for remission, relapse rate per 6 months, and adverse effects of steroids were analyzed in both groups.

Results: There was no significant difference in the time taken for remission in the BW group versus the BSA group (median (IQR) 7 (4.5-9) versus 5.5 (4-8) days; p = 0.082); similar results were observed on subgroup analysis in new-onset and infrequently-relapsing NS (IFRNS). The cumulative prednisolone dosage during the enrolment episode was higher in the BSA group. The incidence of hypertension was higher (p = 0.048) in the BSA group on per-protocol analysis. The relapse rates in the two groups per 6 months on follow-up were comparable.

Conclusions: Clinical outcomes with BW-based dosing are equivalent to BSA dosing-related outcomes, although cumulative prednisolone doses are lower in the former. The practice of BW-based calculations for prescribing prednisolone in NS is a reasonable approach.

Keywords: Body surface area; Body weight; Children; Nephrotic syndrome; Prednisolone.