Investigators from the All India Institute of Medical Sciences in New Delhi, India, conducted a randomized controlled trial to assess the effect of oral daily steroids versus alternate days on relapse rates in children with frequently relapsing nephrotic syndrome (FRNS). Eligible patients included those 2–18 years old who were receiving care at the study institution for recently diagnosed FRNS (≥2 relapses in the previous 6 months or ≥3 in the preceding 12 months) or steroid-dependent nephrotic syndrome. Participants were randomized to daily low-dose prednisolone (0.2–0.3 mg/kg) or prednisolone on alternate days (0.5–0.75 mg/kg) over 12 months. Participants (or their parents) were instructed to monitor proteinuria by using urine dipsticks 2–3 times per week. The study team assessed records of urine examination and performed physical examination every 2 months.
The primary outcome was the incidence of relapses after 12 months of treatment, calculated as the number of relapses per person-year of follow-up. Secondary outcomes included time to first relapse, time to treatment failure (defined as ≥2 relapses in 6 months or ≥3 in 12 months), change in weight and height, and steroid-related adverse effects. Investigators compared the primary outcome by study arm by using incidence rate ratios and compared time to first relapse and treatment failure by using the log-rank test.
Sixty-two patients were randomized, 31 to each group. Baseline demographics and clinical characteristics were similar in the 2 groups. The incidence of relapses in the daily group was significantly lower than in the alternate group (16 per 28.9 person-years vs 42 per 21.6 person-years; incidence rate ratio, 0.28; 95% CI, 0.15–0.52). Time to first relapse and treatment failure were significantly prolonged in the daily (vs alternate) group. There were no differences in height and weight between the 2 groups, and there were similar rates of steroid-related adverse effects.
The investigators conclude that daily low-dose steroid therapy in FRNS is more effective in preventing relapse than alternate day therapy.
Dr Sanchez-Kazi has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.
Nephrotic syndrome is a glomerular disease with incidence of 1–2 per 100,000 and prevalence of 16 per 100,000 children. The most common histologic finding is minimal change. Approximately 80%–90% respond to corticosteroid, but most will relapse.1
Corticosteroid, prednisone or prednisolone, is the mainstay of treatment for the initial presentation and for relapses often triggered by infections. The original recommendation by the International Study of Kidney Disease in Children for initial treatment was a total of 8 weeks: 4 weeks of 60 mg/m2 per day, followed by 4 weeks of 40 mg/m2 per day on 3 consecutive days weekly, later changed to alternate days because of the...