Renal Allograft Tolerance Through Mixed Chimerism
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Successful Withdrawal of Immunosuppressive Therapy
研究概览
简要总结
This study will examine the safety and effectiveness of a combination kidney and bone marrow transplant from a haplo-identical related donor. An investigational medication and other treatments will be given prior to and after the transplant to help protect the transplanted kidney from being attacked by the body's immune system
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18-60 years of age
- •Candidate for a living-donor renal allograft with a one haplotype identical donor identified.
- •First or second transplant with either a living donor or cadaveric transplant as the first transplant.
- •Positive serologic testing for EBV indicating past exposure.
排除标准
- •ABO blood group-incompatible renal allograft.
- •Evidence of anti-HLA antibody within 60 days prior to transplant as assessed by routine methodology (AHG and/or ELISA)
- •Positive testing for: HIV, hepatitis B core antigen, or hepatitis C virus or positivity for hepatitis B surface antigen.
- •Cardiac ejection fraction < 40% or clinical evidence of insufficiency.
- •History of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- •Underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as focal segmental glomerulosclerosis, type I or II nonproliferative glomerulonephritis).
- •Prior dose-limiting radiation therapy.
- •Abnormal (>2 times lab normal) values for (a) liver function chemistries (ALT, AST, AP), (b) bilirubin, (c) coagulation studies (PT, PTT).
- •The presence of any medical condition that the investigator deems incompatible with participation in the trial.
研究组 & 干预措施
Combined Bone Marrow and Kidney Transplantation
Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation
干预措施: MEDI-507 (Drug)
Combined Bone Marrow and Kidney Transplantation
Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation
干预措施: Rituximab (Drug)
Combined Bone Marrow and Kidney Transplantation
Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation
干预措施: Total Body Irradiation (Radiation)
Combined Bone Marrow and Kidney Transplantation
Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation
干预措施: Thymic Irradiation (Radiation)
结局指标
主要结局
Successful Withdrawal of Immunosuppressive Therapy
时间窗: 5 years
The primary endpoint is induction of transient mixed chimerism and renal allograft tolerance without "engraftment syndrome" or "acute kidney injury"
次要结局
- Number of Participants With Engraftment Syndrome(5 Years)
研究者
David Sachs M.D.
Director, Transplantation Biology Research Center
Massachusetts General Hospital