steroids form the mainstay of treatment of idiopathic nephrotic syndrome in children. However use of high dose steroids or large cumulative doses over long periods has been shown to produce various side effects on the short as well as long term. These include hypertension, diabetes, cataract raised intraocular pressure, short stature, osteoporosis, steroid myopathy to list a few prominent ones. More than 80% of children with idiopathic nephrotic syndrome relapse after the first episode with various studies showing that approximately 60% have frequent relapses and 30-40% have a steroid dependent course. It is these children who are at the highest risk for various adverse effects of steroids. One strategy to combat this has been to try to use various steroid sparing agents in children with frequently relapsing or steroid dependent nephrotic syndrome. But they are used in conjunction with steroids and steroids are used to first achieve remission and the standard dose of 1.5 mg/kg/day alternate day for 4 weeks is given followed by slow taper with the steroid sparing agents.  A literature search revealed that this steroid dosing and duration of a relapse is more or less arbitrary and not supported by firm evidence from large trials. We therefore thought that we would re-examine this dosing of treatment of relapse in a Randomized Control Trial to determine if reduction in the dose of steroids used by one third is non inferior to the standard dose. This has huge implications and if proven would go a long way in preventing the development of serious adverse effects of steroid therapy especially in children with frequently relapsing or steroid dependent nephrotic syndrome.

In the proposed study we plan to enroll children with steroid sensitive nephrotic syndrome who have either been on no immunosuppresion in last 6 months or who have been on a stable low dose of steroids or any steroid sparing agent on the same dose for last 6 months. Such children will be randomized to receive either standard dose regime during relapse or reduced dose and studied for outcome variables including number of relapses in children in whom steroid dose is reduced to 1mg/kg alternate day for 4 weeks instead of the standard 1.5 mg/kg/day alternate day in 6 months, proportion of frequent relapsers on the reduced dose regime as compared to standard regime and cumulative steroid dose in two groups for 6 months.

Results: 27 children were enrolled from July 18 to Feb 19. The baseline characteristics of the patients are as mentioned in Table 1.Mean age of enrolment was 4 years + 2.8 months.10 children were not on any medications before enrolment, 9 were on Levamisole and 8 were on MMF. 14 were randomised to reduced steroid dose group. Of them 9 (5 on Levamisole and 4 on MMF) had 2nd relapse within 6 months when treated with reduced dose and were taken off study. The mean time of these children on Levamisole or MMF was 14+2 months. They had an infrequently relapsing course in last 6 months with average number of relapses 0.6/child. However relapses in previous 1 year were 3.2/child. None of the enrolled children who were not on any medications before relapse or who were on low dose alternate day steroids had treatment failure. The relapse rate in these children was also 0.6/child in last 6 months and 0.8 in the calendar year prior to that.  Since 9 children on reduced dose had second relapse in 6 months, we discontinued the study as per stoppage rules.