NCT03764124招募中不适用
Prospective Monocentric Observational Study of Kidney Transplant Recipients at the CHU of Liege for the Prediction of Allograft Survival and Impact of Imaging in Clinical Decision-making.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Imaging
研究概览
简要总结
To further develop personalized medicine in kidney transplantation and improve transplant patient outcomes, attention has been given to define early surrogate endpoints that might aid therapeutic interventions, and help clinical decision-making.
To adequately predict transplant patients' individual risks of allograft loss and patients' complications, this would require a complex integration of data, including: donor data, recipient characteristics, transplant characteristics, biopsies results, immunosuppressive regimen, allograft infections, acute kidney injuries, recipient immune profiles, protocol and per cause biopsies and imaging (PET/CT imaging).
This project aims:
- Assessed the usefulness of 18F-FDG PET/CT imaging in kidney transplantation recipients presenting with suspected acute rejection who underwent a transplant needle biopsy;
- To develop a prognostic risk score to predict kidney allograft survival;
- To evaluate the impact of corticoids withdrawal on long term outcomes (risk of rejection and impact on bone mineral density);
- Evaluate the type and the frequencies of complications in our kidney transplant population
详细描述
- The detection of acute rejection in kidney transplant recipients, depends critically on assessments of serum creatinine, an insensitive measure of renal injury and the diagnosis relies on renal transplant needle biopsy which is an invasive procedure associated with a significant risk of bleeding and graft loss and is limited by sampling error and/or interobserver variability. Moreover, repeated biopsies to evaluate a renal graft's status pose challenges, including practicability and cost. Consequently, other sensitive and less invasive modalities, including gene expression profiling and omic analyses of blood and urine samples as well as in vivo imaging, are currently under investigation to reinforce our clinical armamentarium for acute rejection diagnosis. Likewise, it would be useful to non-invasively predict rejection in kidney transplant recipients with acute renal dysfunction and suspected acute rejection, thereby avoiding unnecessary transplant biopsy.
- This study aims to generate a scoring system that predicts individual patients' risk of long-term kidney allograft failure.
- Since 2007, the protocol in our institution is to withdraw the corticoids after 3 months after the protocol biopsy if no sign of rejection is demonstrated. We would like to evaluate the impact of such decision in the risk of rejection and the long-term allograft outcome in our patients. We are looking also to the impact on bone mineral density after corticoids withdrawal in those patients.
- Evaluate the type and the frequencies of complications in our kidney transplant population to adapt our daily basis clinical practice.
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
- •Kidney recipient transplanted after 2007
- •Kidney recipient over 18 years of age
- •Clinical, biological, immunological and follow up data available
排除标准
- •Combined transplantation
结局指标
主要结局
Imaging
时间窗: Prediction of rejection at time of biopsies
Prediction model of the PET/CT imaging to predict the histological results of a biopsy.
次要结局
- Allograft survival probability post transplantation(Allograft survival probability at 1-year post transplantation)
- Rejection(Evaluation of the risk of rejection during follow-up in patients with corticoids withdrawal at 3 months post transplantation)
研究者
Antoine Bouquegneau
MD
University of Liege
研究点 (1)
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