THYMOGLOBULIN INDUCTION AND STEROID-FREE IMMUNOSUPPRESSION IN KIDNEY TRANSPLANTATION FROM DECEASED DONORS AFTER CARDIAC DEATH-AN OPEN LABEL RANDOMISED CONTROLLED TRIAL TO EVALUATE THE ROLE OF THYMOGLOBULIN AS INDUCTION IMMUNOSUPPRESSION IN KIDNEY TRANSPLANTS FROM DECEASED DONORS AFTER CARDIAC DEATH
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- delayed graft function
研究概览
简要总结
The purpose of this study is to determine if anti-thymocyte globulin (Thymoglobuline) administration in the kidney transplant recipient is able to reduce the amount of damage that kidneys transplanted from deceased donors sustains on reperfusion.
详细描述
The increasing disparity between organ availability and the number of patients on waiting list for a transplant has led to different strategies to improve half life of all transplants. One such method is to reduce the amount of damage the organ sustains during the period of preservation and reperfusion in the recipient. Thymoglobulin, an anti-lymphocyte antibody has been shown to have the ability to reduce this damage in experimental studies. This study aims to ascertain the role of Thymoglobulin in kidney transplants from donors after cardiac death, the type of kidney transplants at highest risk of sustaining injury during preservation. The study will involve comparison with conventional immunosuppressant therapy, comparison between Thymoglobulin administered in different doses, and observation of the patterns of blood cell repopulation (lymphocytes mainly) in the first year following kidney transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study
- •Male or Female, aged 18 years or above
- •Recipient of DCD kidney transplant
- •Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the first 12 months of the study
- •Able (in the Investigators opinion) and willing to comply with all study requirements
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
排除标准
- •The participant may not enter the study if ANY of the following apply:
- •Failure of either recipient of a pair of kidneys to give consent
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- •History of specific viral infection that would contraindicate depleting antibody therapy e.g. hepatitis B&C, HIV
- •Significant hepatic impairment-.i.e. Values 3 times upper limit of normal (unless this is usual for the subject)
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
- •Participants who have participated in another research study involving an investigational product in the previous 12 weeks
- •Previous administration of Thymoglobuline
- •Patients with functioning non-renal transplants and on immunosuppression
- •The patient is not suitable, in the opinion of the Investigator, to take part in the trial
研究组 & 干预措施
Thymoglobulin
Thymoglobulin induction group
干预措施: antithymocyte globulin (Drug)
Basiliximab
Basiliximab induction - 20 mg, day 0 and day 4
干预措施: Basiliximab (Drug)
结局指标
主要结局
delayed graft function
时间窗: 7 days
次要结局
- steroid avoidance(1 year)
- lymphocyte repopulation(1 year)