Clinical and Immunological Outcomes of Living and Deceased Donor Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,293
- 试验地点
- 1
- 主要终点
- the functionality of kidney transplantation
研究概览
简要总结
This is a retrospective, prospective, single-centre, non-pharmacological observational study.
The primary objective is to investigate the long-term prognosis of the kidney transplant function of different types of donors.
详细描述
It provides for the systematic collection of clinical information of patients undergoing kidney transplantation from 01/01/2017 until the Ethics Committee approves the study and the Director General of the IRCCS issues the authorisation. Data collection will continue for 9 years after the start of the study.
Patients participating in the prospective part will be treated according to clinical practice, in accordance with the judgement of the physician and the information reported in the Technical Data Sheet of each individual product of any concomitant therapies administered according to clinical practice. There are no additional study-specific visits/examinations for enrolled patients and any data recorded for the purposes of the study is collected for care purposes during the patient's normal course of treatment.
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 recipient from any donor.
- •Acquisition of Informed Consent to study participation and data processing.
排除标准
- 未提供
结局指标
主要结局
the functionality of kidney transplantation
时间窗: 1 month, 6 months, 1 year, 5 years, 10 years
the functionality of the kidney transplant will be assessed by considering the events of graft failure (return to ESRD, kidney retransplantation), and eGFR change (calculated according to the CKD-EPI formula) at 1 month, 6 months, 1 year, 5 years and 10 years after transplantation. A loss of eGFR of 40% within the first 3 years of follow-up from the baseline visit (at discharge from transplantation) is considered a valid surrogate end-point of ESRD.
次要结局
未报告次要终点