DE NOVO DONOR SPECIFIC ANTIBODIES AFTER KIDNEY TRANSPLANTATION: SINGLE-CENTER RETROSPECTIVE STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 主要终点
- Development of dnDSA in kidney transplant patients
研究概览
简要总结
To investigate the variations of Donor Specific Antibodies in kidney transplant patients based on the type of immunosuppressive therapy adopted and immunosuppressive blood levels.
详细描述
Retrospective observational monocentric study at the U.O.C. of Hepatobiliary Surgery and Transplants of Tor Vergata Polyclinic. All kidney transplant patients in the indicated study period will be enrolled and followed at the U.O.C. clinic.
For each patient, demographic, transplant and post-transplant data will be collected. In the latter, data relating to dnDSA will be registered, searching for a possible triggering cause at the anamnestic level.
The dosage of dnDSA is performed in common clinical practice in a routine manner in all patients undergoing kidney transplant, using the method "Flow cytometric analysis using FlowPRA Screening Test and/or Luminex Single Antigen Beads class I and II- IgG (cut- positivity off = MFI> 1000)".
The blood dosage of the immunosuppressor is measured during routine checks and a comparison is made between Tacrolimus-based immunosuppressive therapy and other immunosuppressive therapy, highlighting the differences in the risk of developing dnDSA and in graft and patient survival.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients,both male and female over the age of 18
- •Patients with at least one year of follow-up
排除标准
- •Combined liver-kidney or pancreas-kidney transplants
- •Re-transplants
- •Patients with follow-up less than one year
结局指标
主要结局
Development of dnDSA in kidney transplant patients
时间窗: • Pre-transplant • Baseline (I PODs) • At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old
Define the incidence of development of dnDSA in patients undergoing kidney transplantation.
次要结局
- Patient survival(5 and 10 years)
- Blood dosage levels of post-transplant immunosuppressive drugs(• At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old)
- Graft survival(5 and 10 years)
- Donor-recipient HLA mismatch(Pre-transplant)
研究者
Roberta Angelico
Associate Professor
University of Rome Tor Vergata