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)

Medical University Of Vienna1 个研究点分布在 1 个国家目标入组 24 人2024年5月31日

概览

阶段: 1/2 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Medical University Of Vienna
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.
状态: 进行中（未招募）
最后更新: 去年

概览研究者入排标准结局指标研究点相似试验

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.

注册库

euclinicaltrials.eu

开始日期

2024年5月31日

结束日期

待定

最后更新

去年

研究类型

Interventional clinical trial of medicinal product

研究者

发起方

Medical University Of Vienna

责任方

Principal Investigator

主要研究者

Division of Transplantation

Scientific

Medical University Of Vienna

入排标准

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.

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 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.