2024-513459-34-00招募中2 期
A prospective controlled trial to evaluate safety and efficacy of in vitro expanded recipient regulatory T cell therapy and tocilizumab together with donor bone marrow infusion in HLA-mismatched living donor kidney transplant recipients (Trex)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Co-primary endpoint 1 (safety) is defined as incidence of GVHD, impaired graft function [eGFR <35mL/min/1.73m2] or patient death, whichever occurs first, within 12 months post-transplant.
研究概览
简要总结
- To examine the safety of Treg therapy together with tocilizumab and donor bone marrow in living donor kidney transplant recipients.
- To assess chimerism levels within the first month post-transplant.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •For recipients (study and control group): Patient has provided written informed consent.
- •For donors (study group only): Participant is 18 years or older.
- •For donors (study group only): Participant is suitable to donate bone marrow according to the guidelines of the Department of Blood Group Serology and Transfusion Medicine.
- •For donors (study group only): WOCBP must not be pregnant at inclusion (i.e. negative pregnancy test).
- •For donors (control group only): Participant has provided written informed consent to donate blood for immune monitoring analyses.
- •For donors (control group only): Participant is 18 years or older.
- •For recipients (study and control group): Patient is 18 years or older.
- •For recipients (study and control group): Patient is a planned recipient of a living donor kidney transplant.
- •For recipients (study and control group): Patient is a planned recipient of an ABO-compatible kidney graft.
- •For recipients (study and control group): Patient is a planned recipient of a kidney graft from a donor that is not HLA-identical.
- •For recipients (study and control group): Patient is negative for DSA.
- •For recipients (study and control group): WOCBP must have a negative pregnancy test at inclusion.
- •For recipients (study and control group): WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the study in such a manner that the risk of pregnancy is minimized.
- •For donors (study group only): Participant has provided written informed consent.
排除标准
- •For recipients (study and control group): Patient is EBV-negative on serology.
- •For recipients (study and control group): Patient is HIV-positive or suffering from chronic viral hepatitis.
- •For recipients (study and control group): Patient is CMV-negative and receiving a kidney from a CMV-positive donor.
- •For recipients (study and control group): Positive T-cell lymphocytotoxic cross match.
- •For recipients (study and control group): Patient with prior kidney transplant or non-renal solid organ transplant.
- •For recipients (study and control group): Patient has a known contraindication to any of the protocol-specified treatments
- •For recipients (study and control group): Patient had been diagnosed with a malignancy within 5 years prior to study entry, excluding non-metastatic basal or squamous cell carcinoma of the skin.
- •For recipients (study and control group): Female patients who are breast-feeding.
- •For recipients (study and control group): Female patients with a positive pregnancy test.
结局指标
主要结局
Co-primary endpoint 1 (safety) is defined as incidence of GVHD, impaired graft function [eGFR <35mL/min/1.73m2] or patient death, whichever occurs first, within 12 months post-transplant.
Co-primary endpoint 1 (safety) is defined as incidence of GVHD, impaired graft function [eGFR <35mL/min/1.73m2] or patient death, whichever occurs first, within 12 months post-transplant.
Co-primary endpoint 2 (efficacy) is defined as the individual peak chimerism levels within the first month post-transplant.
Co-primary endpoint 2 (efficacy) is defined as the individual peak chimerism levels within the first month post-transplant.
次要结局
- To demonstrate that the study protocol allows the initiation of a step-wise reduction of immunosuppression up to a point when patients receive drug monotherapy.
- To gain insight as to whether the study protocol leads to detectable changes in the immune system indicative of pro-tolerogenic immune modulation.
- To assess the frequency of biopsy-proven acute rejection episodes.
- To assess the frequency of subclinical rejection episodes on surveillance biopsies.
- To assess kidney graft function.
- To assess the area-under-the-curve (AUC) of chimerism.
研究者
Division of Transplantation
Scientific
Medical University Of Vienna
研究点 (1)
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