Efficacy, safety and pharmacokinetics of daily versus every other day levamisole therapy in children aged 2-18 years with frequently relapsing or steroid dependent nephrotic syndrome: A prospective open label randomized trial with blinded end point assessment

Post Graduate Institute of Medical Education and Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年11月21日

试验速览

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•Patients with idiopathic steroid responsive nephrotic syndrome with frequent relapses or steroid dependence in the preceding 6-12 months
•Age at onset of frequent relapses or steroid dependence between 2 and 18 years
•Prednisolone requirement <=1 mg/kg on alternate days to maintain remission
•Parents willing to give informed written consent

•Prior therapy with cyclosporine tacrolimus or intravenous rituximab
•Therapy with oral or intravenous cyclophosphamide, and MMF in the preceding 12 months
•Known secondary etiology (e.g. lupus erythematosus IgA nephropathy amyloidosis)
•Known chronic infection (tuberculosis HIV hepatitis B or C)
•Known malignancy epilepsy
•Thrombocytopenia leukopenia neutropenia or deranged liver function tests at enrolment
•Evidence of steroid toxicity: Cataract glaucoma body mass index >30 or height <-3 SD of that expected
•Estimated glomerular filtration rate <60 ml/min/1.73 m2
•Residing more than 200 km away or unwilling to come for regular follow-up

发起方

Post Graduate Institute of Medical Education and Research