EUCTR2017-001604-30-DE进行中（未招募）1 期
Safety, Tolerability and Efficacy of anti-IL-6 Antibody Clazakizumab in Late Antibody-Mediated Rejection after Kidney Transplantation - A Pilot Trial
Charité Berlin0 个研究点目标入组 20 人开始时间: 2018年2月6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
- 20
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 living or deceased donor allograft >365 days post-transplantation
- •- eGFR>30ml/min/1.73m2
- •- Detection of HLA class I and/or II antigen-specific antibodies (preformed and/or de novo DSA)
- •- Acute/active or chronic/active ABMR (±C4d in PTC) according to BANFF 2013/2015
- •- Molecular ABMR score (ABMRpm) =0.2
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- active participation in another clinical trial
- •- age <18 years
- •- female subject is pregnant or lactating
- •- index biopsy results:
- •*T-cell medated rejection classified BANFF grade = I
- •*de novo or recurrent severe thrombotic microangiopathy
- •*Polyoma virus nephropathy
- •* de novo or recurrrent glomerulonephritis
- •- acute rejection treatment <3 months before screening
- •- acute deterioration of graft function (eGFR decline within 1-3 months >25%)
- •- nephrotic range proteinuria >3500mg/g protein/creatinine ratio
- •- Active vrial, bacterial or fungal infection precluding intensified immunosuppression
- •- Active malignant disease precluding intensified immunosuppression
- •- Abnormal liver function tests (ALT, AST, bilirubin >1.5x upper limit of normal)
- •- Other significant liver disease
- •- latent or active tuberculosis (positive QuantiFERON- TB GOD test, Chest X-Ray)
- •- Administration of a live vaccine within 6 weeks of screening
- •- neutropenia (<1 G/L) or thrombocytopenia (<100 G/L)
- •- history of gastrointestinal perforation, diverticulitis, or inflammatory bowel disease
- •- history of alcohol or illicit substance abuse
- •- serious medical or psychiatric illness likely to interfere with participation in the study
研究者
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