EUCTR2012-002857-41-AT进行中（未招募）1 期
Bortezomib in late antibody-mediated kidney transplant rejection (BORTEJECT Study) - Bortezomib in late transplant rejection
niversitätsklinik für Innere Medizin III, Medizinische Universität Wien0 个研究点目标入组 44 人开始时间: 2013年6月18日最近更新:
适应症
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
- 44
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
- •Voluntary written informed consent
- •Age >18 years
- •Functioning allograft after =180 days
- •eGFR >20 ml/min/1.73 m2
- •Serological results
- •HLA class I and/or II DSA-positive
- •Index BX results
- •At least one of the following features (with or without C4d in PTC):
- •Glomerulitis – PTCitis - transplant glomerulopathy - PTC BM lamellation
- •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 34
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Laboratory tests
- •Thrombocytopenia <30 G/l within 2 weeks before enrolment
- •Neutrophil count <1 G/l within 2 weeks before enrolment
- •Clinical evaluation
- •Peripheral neuropathy =grade 2
- •Index BX results
- •Patients actively participating in another clinical trial
- •Female subject is pregnant or lactating*
- •Acute rejection treatment <1 month before screening
- •Acute deterioration of graft function due to suspected acute rejection
- •Active viral, bacterial or fungal infection precluding bortezomib treatment
- •Active malignant disease precluding intensified immunosuppressive therapy
- •Serious medical or psychiatric illness likely to interfere with participation in the study*
- •Documented intolerance of Bortezomib, boron or mannitol
- •T-cell-mediated rejection classified Banff grade >I
- •De novo or recurrent severe thrombotic microangiopathy
- •Polyoma virus nephropathy
- •De novo or recurrent glomerulonephritis in the allograft
研究者
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