EUCTR2013-005503-13-DE进行中（未招募）1 期
A prospective randomized single blind monocenter phase II study of organ perfusion with Custodiol-N compared with Custodiol solution in living donor kidney transplantation - Custodiol
Essen University Hospital, University of Essen, Klinik für Allgemein-, Viszeral- und Transplantationschirugie0 个研究点目标入组 72 人开始时间: 2014年8月12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
- 72
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
入选标准
- •1.all indications for kidney transplantation as defined by local transplant law (TPG, Abs. 4, § 10)
- •2.living donors should fulfil the criteria for living organ donation in accord-ance to local transplant law (TPG, Abs. 3, § 8)
- •3.recipients awaiting their first transplant
- •4.recipients = 18 years
- •5.recipient’s signed informed consent before the transplantation of data use and protection
- •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 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. any contraindication for performance of a kidney transplantation
- •as defined by local transplant law (TPG, Abs. 4, § 10)
- •2. donors or recipients participating in another study involving
- •compound/interventions aimed at the reduction of preservation
- •and/or ischemia/reperfusion injury
- •3. deceased donor kidney transplantation
- •4. pregnant or lactating recipient patients
- •5. female recipients of child-bearing potential who are not using
- •a highly effective contraception method with a pearl-index <1
- •6. multiorgan transplantation
- •7. double kidney transplantation
- •8. perfusion of the kidney by machine perfusion
- •9. repeated kidney transplantation
- •10. Panel reactive antibodies > 85%
- •11. ABO incompatible kidney transplantation
- •12. Known hypersensitivity/anaphylaxis against iron chelators
研究者
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Organ perfusion with Custodiol-N compared with Custodiol solution in living donor kidney transplantatioKidney failureLiving donor kidney transplantationUrological and Genital DiseasesISRCTN44414069Klinik für Allgemein-, Viszeral- und Transplantationschirurgie/ Universitätsklinikum Essen72
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