ormothermic Kidney Perfusion Phase 1

niversity of Oxford0 个研究点目标入组 36 人开始时间: 2021年1月28日最近更新: 2024年3月25日

适应症

试验速览

暂无简介。

•Donor criteria:
•1. Kidneys from deceased donors aged above 16 years
•2. DCD or DBD
•3. Accepted for transplantation according to local criteria
•4. Cold ischaemia time (CIT) prior to NMP no greater than 10 hours
•Recipient criteria:
•1. Male or female, aged 18 years or older
•2. On waiting list for kidney transplantation at Oxford Transplant Centre, Oxford
•3. Provided informed consent for participation in the study
•4. Able and willing to comply with all study requirements (in opinion of investigator or deputy)
•5. Fit to proceed with kidney transplantation
•Matched controls criteria:
•1. Kidneys from donors aged 16 years or over
•2. DBD or DCD
•3. Recipients underwent transplantation of a deceased-donor kidney on or after 01/10/2016

•Donor criteria:
•1. Donor kidneys that would not be accepted according to local criteria
•2. Donor kidneys accepted as a pair for dual transplant
•3. CIT greater than 10 hours prior to initiation of NMP
•Recipient criteria:
•1. Not willing or unable to provide informed consent
•2. Recipients aged less than 18 years
•3. Participation in an investigational study likely to affect on interpretation of the trial data
•4. Undergoing living donor kidney transplantation
•5. Undergoing dual kidney transplantation
•6. Undergoing transplantation of other organ(s) in addition to the kidney
•7. Substantial risk of transplant not proceeding – e.g. risk of positive cross-match (in opinion of Investigator and/ or implanting surgeon)
•8. Other significant disease or disorder which, in the opinion of the Investigator, may: (i) put the participant at risk by participating in the study; (ii) influence the result of the study; (iii) affect the participant’s ability to participate in the study
•Matched controls criteria:
•1. Underwent transplantation of other organ(s) in addition to the kidney
•2. Underwent dual kidney transplantation
•3. Underwent living donor kidney transplantation
•4. 12-month eGFR not available

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