A randomized, controlled trial was conducted in a pediatric unit in a teaching hospital in India to assess the efficacy of
levamisole in maintaining remission in children with
steroid-sensitive nephrotic syndrome. Sixty-one children with
steroid-sensitive nephrotic syndrome, who had achieved remission with
corticosteroids, were allocated to a treatment group (33 patients) receiving
levamisole (2-3 mg/kg/day) twice a week for 12 months or to a control group (28 patients) receiving no treatment. The main outcome measure was duration of remission. Thirty months later, in the
levamisole group, 21 of 33 patients were in remission as against 12 of 28 patients in the control group (chi 2 = 2.54, p = 0.11, NS). The median duration of remission maintenance was 12 months in the
levamisole group as compared with 10.5 months in the control group. On survival analysis, the difference in duration of remission maintenance between the two groups was not significant (p = 0.10), though there was a trend in favor of the treatment group. On stratified survival analysis, multiple relapsers in the
levamisole group had longer remission maintenance than the control group though this did not reach statistical significance (p = 0.08). The clinically significant trend towards increased duration of remission maintenance in
steroid-sensitive nephrotic syndrome observed with
levamisole therapy, especially in patients with multiple relapses, may require a larger study with a longer follow-up for definitive confirmation.