Randomized Controlled Multicentre Trial to Quantify the Benefits of Biomarkers in Routine Patient Care in Kidney Transplant Recipients" EU-TRAIN IMPACT Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 16
- 主要终点
- The rate of biopsies
研究概览
简要总结
The investigator hypothesize that the combined use of (1) non-invasive biomarkers in peripheral blood predicting anti-donor immunological activation or quiescence (2) interactive and actionable data analytics delivered at the bedside will promote safe clinical follow-up of kidney transplant patients with less need for invasive and induced risk surveillance by allograft protocol biopsies to assess allograft rejection in clinically stable kidney transplant patients. It is therefore proposed an European, multicenter, prospective randomized comparing two strategies of follow-up: in the first, biopsies are guided by biomarkers, in the second one, a routine biopsy is performed at M3. In both groups, a biopsy is performed at M12 and whenever considered necessary by the clinician.
详细描述
The main objective of this study is to demonstrate the ability of use of non-invasive biomarkers to decrease the number of allograft biopsies during the first year after transplantation. 300 new transplanted patients in the 7 clinical transplant sites will be included in the prospective multicentre EU-TRAIN Impact study with centralized storage of samples in CHUN (blood mRNA), ICS (blood cellular assays), Saint -Louis Hospital (blood anti-HLA DSA, and non-HLA antibodies), INSERM (Biopsy mRNA). Recruitment of patients will start on the day of transplantation (d-8 for transplantation from living donors) and data/samples collected over the first year following transplantation. Realization of all the acts for the research are representing the usual medical practice (Standard Of Care: SOC) except six additional blood samples that will be collected and analyzed specifically for the research and additional analysis done specifically for the research on half of one of the two biopsy cores from the recipient. 3 additional blood samples from the living donor will also be collected and analyzed specifically for the research (timepoint of the sampling: anytime from 8 days to the day of transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •All men and women, age ≥18 years old.
- •Subject must be a recipient of a single renal transplant from a deceased or living donor.
- •Subject is willing and able to provide signed written informed consent and willing to comply with study procedures
- •Women of Childbearing Potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL]. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of clinical trial
排除标准
- •Subject with Hepatitis B chronic infection and/or active infection by Hepatitis C virus (positive blood PCR result at the moment of transplant).
- •Subjects with known human immunodeficiency virus (HIV) infection.
- •Patients with active systemic infection that requires the continued use of antibiotics.
- •Patients with neoplasia except localized skin cancer receiving appropriate treatment.
- •WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period, women who are pregnant or breastfeeding or women with a positive pregnancy test on enrolment.
- •Subjects who are legally detained in an official institution.
- •Primary non-function or early graft loss due to mechanical/surgical complications.
- •Death within the first 6 months after transplantation.
- •Any condition that, in the opinion of the investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient
- •History of multi-organ transplant (interference with rejection natural history).
研究组 & 干预措施
routine group
Patients will follow a standard clinical follow-up based on kidney allograft function (serum creatinine, estimated glomerular filtration rate (eGFR), proteinuria) and a surveillance allograft biopsies performed at 3 and 12 months after transplantation (M3 and M12). Visits with biopsies for clinical indication are left to the appreciation of the investigator
biomarker guided follow-up
Patients will follow a biomarker-guided strategy based on specific non-invasive biomarkers as defined in EUTRAIN-1 study on the basis of its detection and prediction capacities for rejection at M3 to decide whether a biopsy is performed. At M12 a routine biopsy is performed.
Visits with biopsies for clinical indication are left to the appreciation of the investigator
干预措施: biomarker-guided strategy (Biological)
结局指标
主要结局
The rate of biopsies
时间窗: up to 12 months
comparison of the rate of biopsies performed during the first year in the Group of biomarkers guided biopsies vs. routine Group
次要结局
- Health-related Quality of life (QoL) of transplant patients after receiving a user-friendly reporting format from the EU-TRAIN report.(12 months)
- Rate of complications due to performed biopsies(12month)
- Economic impact of implementing biomarkers in European Healthcare systems (cost/benefit)(up to 12 months)
- Severity of biopsy-proven rejections between both groups(12month)
- Type of biopsy-proven rejections between both groups(12month)
- Outcome of biopsy-proven rejections between both groups(12month)
- Rate of immunosuppressant treatment modifications(12month)
- Incidence of death(12 months)
- Incidence of allograft loss(12 months)