NCT02560220已完成1 期
A Single-arm Phase-I Trial for the Determination of Safety and Feasibility of the Intravenous Administration of Mitomycin C-treated Donor Peripheral Blood Mononuclear Cells (MICs) for Individualized Immunosuppression in Living Donor Kidney Transplant Recipients (TOL-1 Study)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The primary outcome measure is the frequency of adverse events after intravenous administration of MICs within 30 days after transplantation.
研究概览
简要总结
A phase- I clinical trial to determine safety and feasibilty of intravenous administration of mitomycin C-treated donor peripheral blood mononuclear cells in patients with chronic kidney disease stage KDIGO 4 or 5 (i.e. GFR 15-30 mL/min or < 15 mL/min) who receive a kidney transplant from a living donor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic kidney disease stage KDIGO 4 or 5
- •First kidney transplant from a living donor
- •Age ≥ 18 years
- •ABO compatible
- •CDC-PRA < 20%
- •No donor-specific antibodies
- •Negative CDC and ELISA crossmatch
- •Immunosuppression with cyclosporin A, EC-MPS and methylprednisolone
- •Informed consent
- •Adequate contraception (women with child bearing potential)
排除标准
- •Psychiatric disorder
- •Heart failure (NYHA III or IV)
- •Severe liver disease
- •Active hepatitis B or C or HIV infection
- •Active bacterial, fungal or viral disease
- •Malignancy or malignancy in the last 5 years before screening
- •Preexisting immunosuppression
- •Vaccination with a live vaccine in the last 3 months before screening
- •S/p splenectomy
- •Substance abuse
- •Pregnancy or lactation
- •Women: Child/pregnancy with the intended donor
- •Allergy against the investigational drug or part of it
- •Other diseases that prohibit participation in the study (in the opinion of the investigator)
- •Participation in an other interventional study
研究组 & 干预措施
Intervention arm
Experimental
Patients receive MIC cell therapy together with standard immunosuppressive therapy
干预措施: Mitomycin C-induced peripheral blood mononuclear cells (MICs) (Biological)
结局指标
主要结局
The primary outcome measure is the frequency of adverse events after intravenous administration of MICs within 30 days after transplantation.
时间窗: 30 days
次要结局
- Cumulative incidence of infection(30 days)
- Cumulative incidence of CMV reactivation(30 days)
- Number of patients with PTLD(30 days)
- Number of patients with delayed graft function(7 days)
- Number of patients with a pos. CDC and/or ELISA crossmatch(day -1 before transplantation)
- Number of patients with DSA(day -1 before transplantation and day 7 and 30 after transplantation)
- Incidence of biopsy-proven cellular rejection(30 days)
- Incidence of biopsy-proven antibody-mediated rejection(30 days)
- Number of patients with stable graft function (S-creatinine < 2mg/dL)(30 days)
- Patient and graft survival(30 days)
研究者
Christian Morath, M.D.
Martin Zeier, M. D.
Heidelberg University
研究点 (1)
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