Daily compared with alternate-day levamisole in pediatric nephrotic syndrome: an open-label randomized controlled...

Area of Science:

• Pediatric Nephrology
• Immunology
• Pharmacology

Background:

• Levamisole offers a cost-effective and safer alternative to other steroid-sparing agents for nephrotic syndrome.
• Conventional alternate-day levamisole administration contrasts with its relatively short plasma half-life.
• Frequently relapsing or steroid-dependent nephrotic syndrome (FR/SDNS) in children often requires optimized treatment strategies.

Purpose of the Study:

• To evaluate the safety and efficacy of daily levamisole versus alternate-day levamisole in maintaining remission in pediatric FR/SDNS.
• To compare sustained remission rates, relapse frequency, and steroid requirements between the two levamisole administration schedules.

Main Methods:

• An open-label randomized controlled trial involving 190 children with FR/SDNS.
• Group A received daily levamisole; Group B received alternate-day levamisole for 12 months, with a 3-month prednisolone taper.
• Outcomes assessed included sustained remission, relapse rates, steroid dosage, and adverse effects.

Main Results:

• Sustained remission rates were similar (36% daily vs. 27% alternate-day; p=0.18).
• Daily levamisole significantly reduced relapse rates (p=0.03) and cumulative steroid dosage (p=0.02).
• Adverse effects were comparable between groups, with reversible leucopenia and hepatic transaminitis being most common.

Conclusions:

• Daily levamisole is not superior to alternate-day dosing for achieving sustained remission in pediatric FR/SDNS over 12 months.
• Daily administration offers significant benefits by lowering relapse rates and steroid requirements without compromising safety.
• Further research may explore optimal dosing strategies for levamisole in managing FR/SDNS.