Single- versus Divided-Dose Prednisolone for the First Episode of Nephrotic Syndrome in Children: An Open-Label RCT

Area of Science:

• Pediatric Nephrology
• Endocrinology
• Clinical Pharmacology

Background:

• Early morning single-dose prednisolone is hypothesized to reduce hypothalamic-pituitary-adrenal (HPA) axis suppression in nephrotic syndrome.
• Clinical practice varies due to limited evidence, with divided-dose prednisolone still frequently used.

Purpose of the Study:

• To compare HPA axis suppression between single-dose and divided-dose prednisolone in children with a first episode of nephrotic syndrome.
• To evaluate the efficacy and relapse rates associated with different prednisolone dosing strategies.

Main Methods:

• An open-label randomized control trial involving sixty children with first episode of nephrotic syndrome.
• Patients received either single or two divided daily doses of prednisolone for 6 weeks, followed by an alternate daily regimen.
• The Short Synacthen Test was performed at 6 weeks to assess HPA suppression.

Main Results:

• HPA suppression was significantly greater with divided-dose prednisolone (100%) compared to single-dose (83%) after 6 weeks (P=0.02).
• Remission was achieved in all patients, with similar relapse rates between groups during the 6+6 week treatment period.
• Children receiving divided doses experienced a shorter time to first relapse within 6 months (median 28 days vs. 131 days, P=0.002).

Conclusions:

• Single-dose and divided-dose prednisolone are equally effective for inducing remission in nephrotic syndrome with similar relapse rates.
• Single-dose prednisolone demonstrates less HPA axis suppression and a longer time to first relapse.
• Findings support single-dose prednisolone for potentially mitigating endocrine side effects in pediatric nephrotic syndrome management.