Prospective KTD-innov Cohort of Kidney Transplants Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 824
- 试验地点
- 1
- 主要终点
- Concordance of invasive/non-invasive biomarkers with allograft rejection
研究概览
简要总结
Main objective: To constitute a prospective multicentre French cohort of kidney transplant recipients including clinical, biological and immunological evaluation combined with non-invasive biomarkers in peripheral blood and urine, and gene expression assessment in allograft biopsy in order to increase the performance of rejection diagnosis in kidney transplant patients.
the investigators hypothesise that the addition of non-invasive biomarkers and intragraft assessment of gene expression profiles will improve the diagnosis capacity of histology in kidney transplant recipients as it reveals pathophysiological pathways that are not captured by light microscopy.
详细描述
Rejection currently represents the major cause of allograft failure worldwide, with immediate consequences for the patients in terms of mortality, morbidity and costs for the society. The field of transplantation lacks robust assessments for immune monitoring and diagnoses. Currently, light microscopy still represents the gold standard, which has clearly been identified as imperfect. Given those facts, success of clinical trials is impaired with space for improvement of current diagnosis standards that should eventually lead to improved outcomes for kidney transplant recipients.
This study will provide the investigators with prospective data of kidney transplant patient that will allow the improvement of rejection diagnosis and individual immune monitoring for precision medicine: improvement of rejection diagnosis, stage and assessment of response to therapy. In order to estimate for each patient a probability of rejection, The investigators will generate algorithms using traditional clinical, biological and histological data that will be enriched by tissue as well as blood and urine non-invasive immune biomarkers.
These algorithms will be encapsulated in a "user-friendly" web-based application with best in-class visualisation : the TransplanScreen will display individual information with comparative and predictive context for clinicians and patients and better interfacing and communication. It will include a comprehensive TransplanScreen report based on the algorithms and included in Electronic Medical Record databases (object-oriented). It aims to provide visual and contextual information to promote personalised decision making, addressing the demand of public health authorities for improving efficiency and quality of care.
The expected benefit for participants and society will be to reduce the financial burden of graft rejection for society.
The cohort will include n=750 kidney transplant recipients in 8 French centres : 3 Parisian ones: Necker hospital, Saint-Louis Hospital and Bichat hospital and 4 regional ones: CHU Nantes, Toulouse and Bordeaux, Montpellier and Lyon Hospitals. Bichat hospital will not be recruiting but will contribute to the research.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Men or female patients, Age ≥ 18 years old at the time of transplantation. Patients receiving a kidney transplant from a living or deceased donor. Patients who signed the informed consent form and willing to comply with study procedures.
- •Female patients of child-bearing potential must have a negative pregnancy test (serum beta-hCG) and must be practicing an effective, reliable and medically approved contraceptive regimen
- •Patients with a minimum weight of 40 kg
排除标准
- •History of multi-organ transplant (interference with rejection natural history).
- •Unable/unwilling to comply with study procedures (including foreign language speakers who are not assisted by a native French speaker).
- •Vulnerable participants (minors, protected adults, pregnant women, legally detained
结局指标
主要结局
Concordance of invasive/non-invasive biomarkers with allograft rejection
时间窗: month 12
Concordance of invasive/non-invasive biomarkers with allograft rejection diagnosed by the gold standard (histology) in kidney transplant recipients.
次要结局
- Association of non-invasive biomarkers with different subtypes of rejection(month 12)
- Cumulative incidence of T-cell-mediated rejection (TCMR)(month 12)
- Reclassification capacity of gene sets and non-invasive biomarkers to define allograft rejection.(month 12)
- Incidence of delayed graft function(month 12)
- Graft and patient survival(month 12)
- Cumulative incidence of antibody-mediated rejection (ABMR)(month 12)
- Cumulative incidence and duration of dialysis.(month 12)
- Association of gene sets with different subtypes of rejection in the biopsy.(month 12)
- Variation of the non-invasive biomarker signature of allograft rejection(month 12)
- Histological evidence of ABMR and/or TCMR on protocol biopsies(month 12)
- Variation of the gene set signature(month 12)
- Treatment failure rate(month 12)
- Overall pathological changes, including chronic ABMR(month 12)