EUCTR2018-001042-33-IT进行中（未招募）1 期
Efficacy of humanized anti-CD20 antibodies (Ofatumumab) in the treatment of childhood steroid-dependent nephrotic syndrome and development of cell biomarkers predicting outcome. - The OFA3 trial
IRCCS Istituto Giannina Gaslini0 个研究点目标入组 160 人开始时间: 2018年10月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age between 3 and 24 years
- •- Prednison dependent steroid syndrome 0.3-1mg/Kg/day and receive prednisone for at least six months before enrolment. Steroid dependence is defined by two consecutive relapse during corticosteroid therapy or within 14 days of ceasing therapy.
- •- Ability to provide consent and assent: parents’/guardian’s written informed consent, and child’s assent given before any study-related procedure not part of the subject’s normal medical care, with the understanding that consent may be withdrawn by the subject any time without prejudice to his or her future medical care.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Positivity to autoimmunity tests (ANA, nDNA, ANCA)
- •-Reduction of C3 levels.
- •-eGFR<90/ml/min/1,73 m2 valuated according to revised Bedside Schwartz Formula for patients between 2 and 17 years and with CKD-EPI Creatinine 2009 Equation for 18 years old patients.
- •-Pregnancy
- •-Infections: previous or actual HBV (with HBeAb positivity) or HCV infection
- •-CD20 B lymphocytes count <2,5%
- •-Treatment with Rituximab or cyclophosphamide in the last 6 months
研究者
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