A randomized, controlled trial was conducted in a pediatric unit in a
teaching hospital in India to assess the efficacy of levamisole in mai
ntaining remission in children with steroid-sensitive nephrotic syndro
me. Sixty-one children with steroid-sensitive nephrotic syndrome, who
had achieved remission with corticosteroids, were allocated to a treat
ment 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 tr
eatment. The main outcome measure was duration of remission. Thirty mo
nths later, in the levamisole group, 21 of 33 patients were in remissi
on as against 12 of 28 patients in the control group (chi2 = 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 g
roup. On survival analysis, the difference in duration of remission ma
intenance between the two groups was not significant (p = 0.10), thoug
h there was a trend in favor of the treatment group. On stratified sur
vival 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-sensit
ive nephrotic syndrome observed with levamisole therapy, especially in
patients with multiple relapses, may require a larger study with a lo
nger follow-up for definitive confirmation.