Use of Extracorporeal Photopheresis in Kidney Transplantation: Effects on Antibody-Mediated Rejection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Number of participants with response to extracorporeal photopheresis (ECP) at 1 year
研究概览
简要总结
This study aims to describe, over a one-year period, the clinical, biological, and histological evolution of a cohort of kidney transplant recipients who developed antibody-mediated rejection and were treated with extracorporeal photopheresis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 transplant recipients followed at the University Hospitals of Besançon and Lille between September 1, 2016, and August 31, 2023
- •Patients with antibody-mediated rejection (as confirmed by histological analysis of the renal biopsy)
- •Rejection treated with extracorporeal photopheresis
- •Subjects who do not object to the use of their personal data and/or biological samples
- •Subjects affiliated with, or beneficiaries of, the French social security system
排除标准
- •Patients with acute rejection
- •Pregnant women, women in labor, or breastfeeding mothers
- •Individuals deprived of liberty by judicial or administrative decision; individuals receiving compulsory psychiatric care; or individuals admitted to a healthcare or social institution for reasons other than research participation
- •Adults under legal protection or unable to provide informed consent
- •Subjects without health insurance coverage
- •Subjects currently within an exclusion period from another study, or as listed in the "national volunteer registry"
结局指标
主要结局
Number of participants with response to extracorporeal photopheresis (ECP) at 1 year
时间窗: One year after initiation of ECP
Response is defined as either: * stable serum creatinine at 1 year after initiation of ECP, corresponding to a variation within ±20% of baseline serum creatinine (responder); or * a reduction in the slope of creatinine clearance decline following initiation of ECP compared with the pre-treatment trajectory (partial responder). Participants meeting either criterion are considered responders for the primary efficacy analysis.
次要结局
未报告次要终点