POS-462 EFFICACY AND SAFETY OF PREDNISOLONE ON ALTERNATE DAYS MADE DAILY WITH INFECTIONS VERSUS LEVAMISOLE IN FREQUENTLY RELAPSING NEPHROTIC SYNDROME: AN OPEN LABEL RANDOMIZED CONTROLLED TRIAL

Recent RCT suggest that levamisole enables prednisone withdrawal in patients with frequently relapsing nephrotic syndrome (FRNS) & steroid-dependence (SD). Prednisolone on alternate days (AD), made daily during infections, is an strategy to reduce relapses these patients. This open label enrolled patients, 2-18 yr-old, FRNS or SD. Following prednisolone-induced remission and stratification for SD age (4-yr), were randomized 1:1 receive 12-months therapy AD prednisolone (0.5-0.7 mg/kg, infections) (2-2.5 mg/kg AD; tapered by 3-months) [CTRI/2015/07/006002]. Patients high threshold (>1 prednisolone), cataract/glaucoma prior use of either therapy, excluded. Modified intention-to-treat analyses compared, at 1-yr, proportions FR/SD (primary outcome), treatment failure (FR/SD, significant AE necessitating discontinuation intervention, ≥2 serious AE), sustained remission, frequency relapses, received (mg/kg/day), changes anthropometric parameters, time first relapse FR. Based previous RCT, assuming non-inferiority ≤20% versus levamisole, 90% power α=0.05, 152 required be detect between-group differences, allowing 10% loss. Of 238 screened, 160 80 each allocated ot levamisole; all included analysis (Fig 1). Baseline characteristics comparable (Table Outcomes, tabulated Table 2, indicate preventing could not demonstrated; frequent significantly fewer administered levamisole. The comparable; both groups showed considerable reduction rates usage. Changes anthropometry similar between improved from baseline. Serious few proportion groups. Per protocol results (data shown). 1. characteristicsTable 2.Outcomes 12 months end studyView Large Image Figure ViewerDownload Hi-res image Download (PPT) Results this trial have implications guiding the choice initial FRNS. While was non-inferior therapies enabled rates. Levamisole provided more-steroid sparing, may preferred agent children risk steroid toxicity.