Catalytic Antibodies to Predict Uninvasively Late Transplant Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)
研究概览
简要总结
Chronic Allograft Nephropathy (CAN), a major cause of late allograft failure, is characterized by a progressive decline in graft function correlating with tissue destruction. Recent data suggest that it may be possible to delay graft destruction if adequate management is initiated early (ie, at the stage of subclinical CAN). It is therefore essential to design new tests allowing physicians to predict transplant recipients prone to develop CAN
详细描述
Superantibodies are multifunctional antibodies combining the classical antigen-binding function with nonclassical biological activities, such as protease-like activity. In the past few years the role of proteolytic SuperAntibody (pSAb) has been evidenced in many biological processes in which their role may be either deleterious (autoimmune disease, alloimmune response against) or beneficial (sepsis).
Nothing is known so far regarding the role of pSAb in the setting of solid organ transplantation.
Preliminary data
The investigator has obtained preliminary results from a retrospective case control study indicating that an elevated serine protease activity of circulating IgG (measured by the hydrolysis of a synthetic fluorescent substrate: Proline-Phenylalanine-Arginine-Methylcoumarinamide (PFR-MCA)), correlates with the absence of CAN on protocol biopsy performed 2 years post-transplantation. Interestingly, low level of proteolysis IgG, measured 3 months post-transplantation, were also predictive of CAN at 2 years down the lane.
Aim of the Research project:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age > 18 the day of transplantation
- •Recipient of a renal graft
- •Informed consent to participate to the study
- •Patient transplanted and followed 2 years in one of the 3 transplantation centers of the study (Hospital Edouard Herriot or Centre Hospitalier Lyon Sud)
排除标准
- •Multiorgan transplantation
- •Previous transplantation
- •ABO incompatible renal transplantation
- •Patient > 18 years old but under guardianship
结局指标
主要结局
PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)
时间窗: at 24 months post-transplantation
次要结局
- Glomerular filtration rate by MDRD formula (ml/min)(at 24 months post-transplantation)
- Interstitial fibrosis on graft biopsy (%)(at 24 months post-transplantation)
- Proteinuria/creatinuria ratio (g/g)(at 24 months post-transplantation)