This was a controlled prospective study on the use of an
immunomodulator drug,
levamisole, in the treatment of frequently relapsing,
steroid-dependent (FR/SD) idiopathic
nephrotic syndrome. The study was started on 1 January 2001 and completed on 31 December 2003. There were two groups: a treatment group who received
levamisole (2.5 mg/kg) on alternate days for 1 year and a control group who received low-dose
prednisolone only (<0.5 mg/kg) on alternate days for 1 year. There were a total of 56 patients (32 in the treatment group and 24 in the control group). The male to female ratio was 1.66:1 in both groups. The mean age upon initial diagnosis was 3.3 years in the
levamisole group versus 4.3 years in the control group. The mean duration from diagnosis to the start of the second line treatment was 3.2 years in the
levamisole group versus 2.8 years in the control group. The relapse rate and the total cumulative dose of
prednisolone during the year prior to second line
therapy was compared to that during the year following the institution of second line
therapy in 56 patients. The mean relapse rate was reduced more significantly in the
levamisole group. It was reduced by 0.29 versus 0.11 relapses/patient/month in the control group (P =0.0001). The mean cumulative dose of
steroids was also reduced more significantly in the
levamisole group. It was reduced by 293 versus 102 mg/m(2)/month in the control group (P <0.0001).
Therapy failure was seen in 3/32 (9.4%) in the
levamisole group versus 12/24 (50%) in the control group. Of the patients, 20/32 (62.5%) using
levamisole were relapse-free in the follow-up year post
therapy, while no patient was relapse-free in the control group over the same period. No major adverse effects of
levamisole were seen. The cost of
levamisole therapy was estimated to be US$ 25 per year for a 20-kg
body weight child. Thus, we concluded that
levamisole is a highly efficacious, safe and easily affordable initial
therapy for FR/SD idiopathic
nephrotic syndrome.