Comparison of cyclosporin and chlorambucil in the treatment of steroid-dependent idiopathic nephrotic syndrome: a multicentre randomized controlled trial. The French Society of Paediatric Nephrology.

Forty children with steroid-dependent idiopathic nephrotic syndrome and signs of steroid toxicity were randomly assigned to receive either cyclosporin 6 mg/kg body wt. per day for 3 months and at tapering doses over the next 3 months or chlorambucil at a cumulative dose of 8 mg/kg body wt. The two groups of patients did not differ significantly in sex distribution, age of onset of disease, duration of disease, number of relapses and histological findings. Of the 20 patients treated with cyclosporin, 4 relapsed before or on discontinuation of prednisone, 7 relapsed when the initial dose of cyclosporin was tapered, and 8 after withdrawal of cyclosporin. Of the 20 patients treated with chlorambucil, 14 relapsed while 6 were still in remission 27-49 months after completion of the treatment course. Thus the actuarial remission rate at 2 years was 45% after a course of chlorambucil compared with only 5% after a 3-month course of cyclosporin. We believe that children with steroid-dependent idiopathic nephrotic syndrome should be treated with a course of chlorambucil before resorting to cyclosporin.

RCT Entities:   Population Interventions Outcomes