Tissue Study on the Chronic Active Humoral Rejection (cAMR) Population of Kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Kidney survival post tranplant
研究概览
简要总结
The study is tissue-based, retrospective and prospective, single-centre, non-sponsored.
Primary objective: To examine patient and organ survival and eGFR variation in kidney transplant patients diagnosed histologically with cAMR.
详细描述
At the kidney transplant follow-up clinic of the UO Nephrology, Dialysis and Transplantation Unit of the IRCCS AOUBO Policlinico di Sant'Orsola, directed by Prof. G. La Manna, all patients with a diagnosis of cAMR made since 01/01/2018 and patients with a new diagnosis of cAMR made after the approval of this protocol by the Ethics Committee will be enrolled.
The study will last 5 years and 6 months.
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
- •Age ≥18 years
- •Kidney transplant recipients
- •eGFR>15 ml/min/1.73 sq m at the time of diagnosis of cAMR
- •cAMR diagnosis defined on the basis of the 2018 Banff Classification (17), made after 1/1/
- •Obtaining Informed Consent to Participation.
排除标准
- •Combined transplant patients (heart-kidney, liver-kidney or kidney-pancreas)
- •Histological evidence of concomitant disease (e.g. recurrence of original nephropathy or diagnosis of 'de novo' nephropathy, acute cellular rejection, polyomavirus BK nephropathy, other)
结局指标
主要结局
Kidney survival post tranplant
时间窗: 1 year, 2 years
Patient and organ survival status
Change in eGFR
时间窗: 1 year, 2 years
The change in eGFR will be assessed by the linear slope of eGFR (least square method) in patients who have at least 3 serum creatinine assessments. In addition to the mean annual change in eGFR from the baseline visit, it will be assessed how many patients achieved a reduction in eGFR of 40% and 50% (percentage change) between the baseline visit and the 1- and 2-year follow-up visits.
次要结局
未报告次要终点