Autologous Tolerogenic Dendritic Cells (ATDC) for Highly Sensitized Kidney Transplant Recipients
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Side effects of ATDC cell product in highly sensitized patients who received a kidney from a deceased donor.
研究概览
简要总结
The ATDC-PICI study is a Phase Ib, single-arm, prospective, non-randomized, multicentric trial, to evaluate the safety of ATDC cell product as adjunctive therapy to standard of care (SOC) in highly sensitized kidney transplant recipients.
详细描述
The study population is sensitized kidney transplant candidates (cPRA ≥ 90%) between 18 and 65 years.
An algorithm has been designed to rank highly sensitized patients on the waiting list for kidney transplantation according to their likelihood of obtaining a suitable donor within the upcoming 12 months. The algorithm was designed based on an analysis of an immunologically matched historical cohort using data from the OCATT registry.
Patients will be selected in accordance with the algorithm and proposed for inclusion in the study in a sequential manner until the required number of patients has been reached (n=30). Given the unpredictability and reduced likelihood of obtaining a compatible deceased kidney donor within an acceptable time frame for this study, the total number of patients to be included will be 2x superior to those who will receive treatment with ATDC (n=15).
- 30 highly sensitized patients will be pre-included in the study.
- The first 15 highly sensitized patients that obtain a compatible deceased kidney donor will be included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Highly sensitized (cPRA ≥ 90%) kidney transplant candidates between 18 and 65 years old.
- •To be selected by the algorithm according to probability of kidney transplantation in the upcoming 12months.
- •Adequate venous access and absence of contraindications for leukoapheresis.
- •Women of childbearing age must take contraceptive measures.
- •Must have given written informed consent
排除标准
- •Subjects with active TB.
- •Patients on the waiting list multiple organ transplants.
- •A significantly abnormal general serum screening lab result defined as WBC<3.0x103/ml, Hgb<8.0 g/dL, platelet count <100x103/ml, SGOT>3x upper limit.
- •HIV-positive subjects.
- •Subjects who test positive for HBV infection [positive HBVsAg or HBVeAg/DNA] or HCV infection [RNA+].
- •Subjects with active CMV or EBV infection as defined by positive PCR.
- •Subjects with a known history of previous myocardial infarction within one year of screening.
- •Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.
- •Patients with a kidney disease with high risk of recurrence and/or complement-associated kidney disease (aHUS, etc).
- •Pregnant and lactating women.
研究组 & 干预措施
Treatment
An algorithm has been designed to rank highly sensitized patients on the waiting list for kidney transplantation according to their likelihood of obtaining a suitable donor within the upcoming 12 months. The algorithm was designed based on an analysis of an immunologically matched historical cohort using data from the OCATT registry.
Patients will be selected in accordance with the algorithm and proposed for inclusion in the study in a sequential manner until the required number of patients has been reached (n=30). Given the unpredictability and reduced likelihood of obtaining a compatible deceased kidney donor within an acceptable time frame for this study, the total number of patients to be included will be 2x superior to those who will receive treatment with ATDC (n=15).
- 30 highly sensitized patients will be pre-included in the study.
- The first 15 highly sensitized patients that obtain a compatible deceased kidney donor will receive study treatment.
干预措施: Autologous Tolerogenic Dendritic Cells (Biological)
结局指标
主要结局
Side effects of ATDC cell product in highly sensitized patients who received a kidney from a deceased donor.
时间窗: at day 1 and day 3
Proportion of patients with toxicity/side effects during and after administration.
次要结局
- Rate of infectious disease that required hospitalization at 6 and 12 months.(at 6 months and 12 months.)
- To evaluate incidence of biopsy proven acute rejection episodes in patients treated with ATDC as adjunctive therapy to SOC(at 3 and 12months after transplantation.)
- To evaluate renal function up to 1 year after transplantation(at 3, 6 and 12 months after transplantation)
- To evaluate patient survival(at 12 months after transplantation)
- To evaluate graft survival(at 12 months after transplantation)
- To characterize the immunophenotype status.(24 months)