NCT04540380进行中（未招募）1 期
Renal Allograft Tolerance Through Mixed Chimerism - SMC/MGH
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence of Chimerism Transition Syndrome
研究概览
简要总结
The goal is to investigate the safety of the conditioning regimen, and its ability to induce donor/recipient lymphohematopoietic chimerism without Chimerism Transition Syndrome (CTS), which may result in donor-specific unresponsiveness (tolerance) to the renal allograft in the absence of maintenance immunosuppression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 18-65 years of age.
- •Candidate for a living-donor renal allograft from an HLA mismatched donor
- •Subjects with chronic kidney disease stage or ESRD who are treated with either hemodialysis or peritoneal dialysis.
- •First transplant.
- •Use of FDA-approved methods of contraception
- •Ability to understand and provide informed consent.
- •Negative COVID at screening and 2 days before procedure
排除标准
- •ABO blood group-incompatible renal allograft.
- •Participant with a (non DSA) PRA > 20% within 6 months prior to transplant
- •Persistent Leukopenia (WBC less than 2,000/mm3) or thrombocytopenia (<100,000/mm3).
- •Seropositivity for HIV-1, hepatitis B core antigen, or hepatitis C virus (confirmed by hepatitis C virus RNA); or positivity for hepatitis B surface antigen.
- •Active infection
- •Left ventricular ejection fraction < 40% as determined by TTE or clinical evidence of heart failure
- •Forced expiratory volume FEV1 or DLCO < 50% of predicted.
- •Lactation or pregnancy
- •History of cancer (following the American Transplant Society Guidelines)
- •Underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as focal segmental glomerulosclerosis).
- •Prior dose-limiting radiation therapy
- •Known genetic disease or family history that may result in greater sensitivity to the effects of irradiation, or a physical deformity that would preclude adequate shielding or appropriate dosing during the irradiation component of the conditioning regimen
- •Enrollment in other investigational drug studies within 30 days prior to enrollment
- •Abnormal (>2 times lab normal) values for (a) liver function chemistries (ALT, AST, AP), (b) bilirubin, (c) coagulation studies (PT, PTT).
- •Allergy or sensitivity to any component of Siplizumab, Fludarabine, Cyclophosphamide, tacrolimus, DMSO, MMF or rituximab.
- •The presence of any medical condition that the investigator deems incompatible with participation in the trial.
- •Subjects who have non-insulin dependent diabetes (NIDDM) without good blood glucose control (HbA1c<7). Subject with severe retinopathy, gastroparesis, or severe neuropathy which prevent subject's normal independent daily activities will be excluded from the study
结局指标
主要结局
Incidence of Chimerism Transition Syndrome
时间窗: 36 months after immunosuppression withdrawal
Incidence of tolerance induction
时间窗: 36 months after immunosuppression withdrawal
Incidence of Transient Chimerism
时间窗: 36 months after immunosuppression withdrawal
次要结局
未报告次要终点
研究者
Tatsuo Kawai, MD, PhD
Principal Investigator
Massachusetts General Hospital
研究点 (2)
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