Initial treatment of idiopathic nephrotic syndrome in children: prednisone versus prednisone plus cyclosporine A: a prospective, randomized trial

Abstract

Previous studies of the Arbeitsgemeinschaft für Pädiatrische Nephrologie in children with steroid-sensitive nephrotic syndrome have shown that the length of initial prednisone therapy has an impact on the subsequent relapse rate. The aim of this randomized, prospective, multicenter study was to reduce the number of relapses further by increasing the initial immunosuppression: Patients with an initial attack of nephrotic syndrome were randomly allocated to treatment with 6 wk of 60 mg/m(2) per d prednisone followed by 6 wk of 40 mg/m(2) per 48 h (Pred group) or to the same prednisone treatment plus 8 wk of cyclosporine (Pred+CsA group). The primary end point was first relapse; follow-up was truncated at 2 yr. In the Pred+CsA group (n = 49 patients), the first relapse occurred later compared with the Pred group (n = 55 patients) (median 22.8 versus 12.5 mo). After 6 mo, 10.4% of patients in the Pred+CsA group experienced a first relapse versus 31.5% in the Pred group (P = 0.01); after 1 yr, 36.5 versus 51% (P = 0.15); and after 2 yr, 51 versus 50%. The mean relapse rate per patient was 0.12 versus 0.57 after 6 mo (P = 0.01), 0.63 versus 1.03 after 1 yr (P = 0.02), and 1.03 versus 2.06 after 2 yr (not significant). The significant benefit for adding CsA was lost after 9 to 12 mo. GFR remained unchanged. The subsequent treatment rate with cyclophosphamide was lower in the CsA group (five versus 12 patients) after 2 yr. With the use of logistic regression statistics, children who were younger than 7 yr show a significantly better sustained remission rate with initial CsA treatment for the 2-yr observation time (P = 0.03). It remains questionable, however, whether the intensified initial treatment with CsA could be recommended generally.