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临床试验/NL-OMON44222
NL-OMON44222招募中3 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 Universitair Medisch Centrum0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
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

入排标准

年龄范围
18 至 99(—)

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

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

研究者

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