Randomized controlled trial to compare the efficacy and safety of converting alternate day to daily prednisolone during infections versus levamisole in children with frequently relapsing and steroid dependent nephrotic syndrome

Indian Council of Medical Research0 个研究点目标入组 138 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•a) Patients with idiopathic steroid responsive nephrotic syndrome with frequent relapses or steroid dependence in the preceding 6 months
•b) Age at onset of frequent relapses or steroid dependence between 2 and 18 years
•c) Prednisolone requirement <=1 mg/kg on alternate days to maintain remission
•d) Parents willing to give informed written consent

•a) Known etiology (e.g., systemic lupus erythematosus, IgA nephropathy, amyloidosis)
•b) Prior therapy with levamisole, cyclosporine, tacrolimus or azathioprine
•c) Therapy with oral or intravenous cyclophosphamide or intravenous rituximab in the preceding 6 months
•d) Thrombocytopenia, leukopenia or deranged liver function tests
•e) Known chronic infection (tuberculosis, HIV, hepatitis B or C)
•f) Known malignancy
•g) Severe malnutrition (WHO classification); body mass index >30 or height <-2 SD of that expected (NCHS)
•h) Presence of cataract or glaucoma
•i) Estimated glomerular filtration rate <60 ml/min/1.73 m2
•j) Residing more than 100 km away or unwilling to come for regular follow-up

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