NL-OMON45147招募中2 期
Prospective donor-specific Cellular alloresponse assessment for Immunosuppression Minimization in de novo renal transplantation - CELLIMI
Charite Universiteitskliniek Berlijn0 个研究点目标入组 200 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1) Men and women, age >=18 years.
- •2) Subject must be a recipient of a first renal transplant from a deceased or living donor.
- •3) Subject must have a current documented PRA <20% and no detectable anti-class I and II HLA antibodies by solid phase assay (Luminex®).
- •4) Subject is willing to provide signed written informed consent.
排除标准
- •1) Subjects undergoing renal transplant with a current documented PRA >20% and/or detectable anti-class I and II HLA antibodies by solid phase assay (Luminex®).
- •2) CDC positive cross match.
- •3) Subjects receiving an allograft from a donor older than 65 years with elevated creatinine levels and/or treated diabetes.
- •4) Cold ischemia time (CIT) higher than 24h.
- •5) Subjects with a prior solid organ transplant (SOT), including renal re-transplantation, or receiving a concurrent SOT.
研究者
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