CTRI/2018/11/016342尚未招募未知
Efficacy and safety of intravenous rituximab versus tacrolimus in frequently relapsing nephrotic syndrome
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Idiopathic steroid responsive (sensitive) nephrotic syndrome with age 3-18 years
- •Frequently relapsing course with a relapse in the last 3 months
- •Failure of >=2 alternative agents (eg, long term corticosteroids on alternate days, levamisole, oral cyclophosphamide, mycophenolate mofetil (MMF) [Failure of cyclophosphamide defined as occurrence of 2 relapses after 6 months of completing therapy; that for levamisole, long term alternate day steroids and mycophenolate mofetil defined as occurrence of two relapses within last 6 months ; failure of therapy also includes serious therapy-associated adverse effects]
- •Remission confirmed by dipstick
- •Parents willing to give informed written consent
排除标准
- •Known secondary cause for nephrotic syndrome (e.g., lupus erythematosus, IgA nephropathy, amyloidosis)
- •rior therapy with cyclosporine or tacrolimus (either drug for >1 week duration)or intravenous rituximab ever
- •Estimated glomerular filtration rate <60 ml/min/1.73 m2
- •Leukopenia (ANC<=1500/mm3), thrombocytopenia, deranged liver function tests or hyperglycemia (fasting blood sugar >=126 mg% or HbA1c>=6.1%) at enrolment
- •Known malignancy
- •Previous history of >=1 episode of seizures which are not explained by acute metabolic disturbances(hypoglycemia, hypocalcemia, hyponatremia), hypertension or simple febrile seizures
- •Recent infection requiring hospitalization in the last 3 weeks
- •Patients in whom information regarding disease course and treatment is not available for the last six months
- •Past or present infection with HIV/HBV/HCV
研究者
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