ISRCTN11038572进行中（未招募）2 期
The TWO study: Transplantation Without Over-immunosuppression - a Phase IIb trial of regulatory T cells in renal transplantation
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 136
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35428650/ (added 17/05/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Kidney recipient inclusion criteria:
- •1. Chronic renal insufficiency necessitating kidney transplantation and approved to receive a kidney allograft from a living donor
- •2. Willing and able to give informed consent for participation in the trial
- •3. Aged 18 years or above
- •4. In the Investigator’s opinion, is able and willing to comply with all trial requirements
- •5. Able to commence the immunosuppressive regimen at the protocol-specified time point
- •6. Female participants of child bearing potential and male participants whose partner is of childbearing potential must be willing to ensure that they or their partner use highly effective contraception during the trial
- •7. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial
- •Kidney donor inclusion criteria:
- •1. Eligible for live kidney donation
- •2. Aged at least 18 years
- •3. ABO blood group compatible with the organ recipient
- •4. Willing to provide personal, medical and biological data for the trial analysis
- •5. Willing and able to provide a blood sample for the immune monitoring assays
- •6. Willing and able to give informed consent for participation in the trial
排除标准
- •Kidney recipient exclusion criteria:
- •1. Patient has previously received any tissue or organ transplant
- •2. Known contraindication to the protocol-specified treatments or medications
- •3. ABO blood group incompatible with donor
- •4. Calculated reaction frequency (CRF) of >40% within 6 months prior to transplant
- •5. Previous treatment with any desensitisation procedure (with or without IVIg)
- •6. 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)
- •7. Serologically positive for anti-HIV-1/2 Ab, HbsAg, anti-HBcAb, antiHCV Ab, anti-HTLV-1/2 Ab or syphilis (treponema palladium)
- •8. Significant liver disease, defined as persistently elevated ALT levels >3 x upper limit of normal range (ULN)
- •9. 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
- •10. Participation in another clinical trial during the study or within 28 days prior to planned study entry
- •11. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- •12. Psychological, familial, sociological, or geographical factors potentially hampering compliance with the study protocol and follow-up visit schedule
- •13. 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 donor exclusion criteria:
- •1. Exposure to any investigational agents at the time of kidney donation, or within 28 days prior to kidney donation
- •2. Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator designated personnel
- •3. Is a paired exchange donor
- •4. Is an altruistic donor
研究者
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