ISRCTN85447324已完成不适用
Erythopoietin and delayed graft function in renal allografts from extended criteria donors: a single centre, randomised, double blind, parallel-group, placebo controlled trial
Central Manchester and Manchester Children's University Hospital (CMMCUH) NHS Trust (UK)0 个研究点目标入组 40 人开始时间: 2009年8月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 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
- 性别
- All
入选标准
- •1. Men and women aged greater than or equal to 18 years
- •2. The subject is willing to provide signed written informed consent
- •3. The subject is the recipient of a deceased donor kidney transplant
- •4. The donor and/or donor kidney meet at least one of the following extended criteria for organ donation from either 4.1. or 4.2. as described below:
- •4.1. Donor:
- •Greater than 50 years with:
- •4.1.1. Cerebrovascular accident (CVA) + hypertension (HTN) + serum creatinine (SCr) greater than 1.5
- •4.1.2. CVA + HTN
- •4.1.3. CVA + SCr greater than 1.5
- •4.1.4. HTN + SCr greater than 1.5
- •Greater than 60 years with:
- •4.1.5. CVA
- •4.1.6. HTN
- •4.1.7. SCr greater than 1.5
- •4.2. Additional criteria cold ischaemia time (CIT) greater than or equal to 24 hours
排除标准
- •1. Women who are pregnant or breastfeeding
- •2. Women with a positive pregnancy test on enrolment
- •3. Subjects with any active infection that would normally exclude transplantation
- •4. Subjects who have used any other investigational drug within 30 days prior to transplantation
- •5. Subjects with a haemoglobin level greater than or equal to 15 g/dl
- •6. Subjects with a diastolic blood pressure greater than 100 mmHg pre-transplantation
- •7. Subjects previously intolerant of NeoRecormon®
研究者
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