EUCTR2017-003366-27-NL进行中（未招募）1 期
Efficacy of rituximab in comparison to continued corticosteroid treatment in idiopathic nephrotic syndrome unresponsive to 8 weeks of high dose prednisone. - Rituximab in SRNS
Radboud University Nijmegen Medical Center0 个研究点目标入组 40 人开始时间: 2017年10月10日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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 = 18 years
- •Persistent proteinuria = 2 g/ 24 hours or a protein-to-creatinine ratio = 2 g/10mmol (2 g/g) after 8 weeks of treatment with high dose prednisone 1 mg/kg/day (max 80 mg/day)
- •Idiopathic nephrotic syndrome caused by biopsy proven minimal change disease or focal segmental glomerulosclerosis
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Severe nephrotic syndrome with hypotension
- •Previous treatment with immunosuppressive medication other than prednisone
- •Treatment with prednisone > 10 weeks in last six months
- •Secondary form of FSGS or minimal change disease
- •Patients who test positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody
- •(anti-HBc).
- •Patients infected with HIV or suffering from other active infections
- •Patients inoculated with a live vaccine within 4 weeks prior to inclusion
- •Pregnancy, breast feeding, women with inadequate contraception
- •Malignancy
- •Kidney transplantation
- •Previous treatment with monoclonal antibodies
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