A Response-Adjusted Prednisone Protocol for Children with Newly Diagnosed Idiopathic Nephrotic Syndrome

Background: All children with initial presentation of idiopathic nephrotic syndrome are treated with similar prednisone protocols in terms of dose and duration of administration, although the time to response varies widely. This study sought to assess the safety and effectiveness of a novel response-adjusted protocol for early responders.

Methods: A prospective interventional study was conducted at a tertiary pediatric medical center in Israel between 2014-2017. The cohort included 36 children with newly diagnosed idiopathic nephrotic syndrome who responded to prednisone treatment within 8 days. Clinical outcomes were compared between the control group (n=19) treated with the standard protocol (60mg/m2/24h, followed by 40mg/m2/48h, two weeks each, followed by a slow taper down; total 24 weeks) and the study group (n=17) treated with a dose-adjusted protocol (60mg/m2/24h for 2 weeks followed by 45mg/m2/24h for 2 weeks, 30mg/m²/48h for 2 weeks and 15mg/m2/48h; total 8 weeks).

Results: There were no cases of relapse in the study group during the shorter initial treatment. At 24 months, there were no significant between-group differences in the proportion of patients with frequently relapsing nephrotic syndrome (29% vs 47%, p=0.27). The mean one-year prednisone cumulative dose was 260mg/kg in the control group and 100mg/kg in the study group (p=0.001).

Conclusions: A response-adjusted prednisone protocol is safe and effective for use in children with idiopathic nephrotic syndrome who respond to the initial prednisone dose within 5-8 days. With the new protocol we can reduce the first-year cumulative prednisone dose. A large multicenter study is needed to corroborate our results.