EUCTR2017-001421-41-GB进行中（未招募）1 期
The TWO Study: Transplantation Without Over-immunosuppression.A Phase IIb Trial of Regulatory T Cells in Renal Transplantation. - TWO Study: Treg Cell Therapy Trial v1.0
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 136
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
- 性别
- All
入选标准
- •Kidney Donor:-
- •- aged at least 18
- •- ABO blood group compatible with the recipient
- •- eligible for live kidney donation
- •- willing and able to give informed consent for participation in the trial
- •Kidney Recipient
- •- Chronic renal insufficiency necessitating kidney transplantation and approved to receive a primary kidney allograft from a living donor
- •- Willing and able to give informed consent for participation in the trial
- •- Aged over 18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 108
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •Kidney Donor
- •- Participation in another interventional clinical trial during the study or within 28 days prior to planned study entry
- •- Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the investigator, may invalidate communication with the investigator and/or designated personnel
- •Kidney Recipient
- •The potential participant has previously received any other type of tissue or organ transplant
- •Known contraindication to the protocol-specified treatments or medications
- •ABO blood group incompatible with donor
- •Calculated reaction frequency (CRF) of >40% within 6 months prior to transplant
- •Previous treatment with any desensitisation procedure (with or without IVIg)
- •Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully treated non-metastatic basal or squamous cell carcinomas of the skin)
- •Serologically positive for anti-HIV-1/2 Ab, HbsAg, anti-HBcAb, antiHCV Ab, anti-HTLV-1/2 Ab or syphilis (treponema palladium)
- •Significant liver disease, defined as persistently elevated ALT levels >3 x upper limit of normal range (ULN)
- •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 trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
- •Participation in another interventional clinical trial during the study or within 28 days prior to planned study entry
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- •Psychological, familial, sociological, or geographical factors potentially hampering compliance with the study protocol and follow-up visit schedule
- •Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the investigator, may invalidate communication with the investigator and/or designated personnel
研究者
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