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

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. 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 6months, and adverse effects of steroids were analyzed in both groups. 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 6months on follow-up were comparable. 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.