Molecular Markers of Acute Kidney Injury in Elderly Deceased Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Kidney graft function at month 3
研究概览
简要总结
Scoring systems that combine donor clinical and morphological parameters to predict outcome of kidney transplantation lack enough specificity to be generally accepted. Compare to classical histology, molecular assessment of renal tissue offers unbiased and technically robust approach. In this prospective 3-months' observational study procurement biopsies in 180 brain death donors will be performed. Using microarray which detect top differently regulated genes, conventional histology, urinary AKI biomarkers, renal function and clinical variables models predicting DGF and early graft scarring (IFTA, poor graft function) in recipients will be constructed. The associations of AKI in donors with distinct fibrosis atrophy and AKI molecular signals will be found. Molecular techniques and final models may help to improve the decision-making process for the acceptance of kidneys from marginal donors but more importantly, it may help clinicians to guide less toxic immunosuppression in identified problematic grafts.
详细描述
The aim is to create a prediction model of early clinical outcome (delayed graft function) based on donor and recipient clinical variables, donor eGFR, urinary AKI biomarkers, histology (glomerulosclerosis, interstitial fibrosis, vascular changes) and top differently regulated genes found in microarray of wedge procurement donor biopsy. Construct a model capable to predict early renal allograft scarring (IFTA>2), and impaired graft function (eGFR<45 mL/min), as early as at 3 months. Describe renal molecular changes associated with established AKI in brain-death deceased donor and with aging.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All DBD (donation after brain death) donors whose kidneys will be procured by transplant team of Institute for Clinical and Experimental Medicine (IKEM) in donor hospital.
- •All DBD (donation after brain death) donors whose kidneys will be procured by transplant team of Institute for Clinical and Experimental Medicine (IKEM) at IKEM.
排除标准
- •Donors with circulatory death
- •Donors with machine perfusion
- •Donors with multiorgan transplantation.
结局指标
主要结局
Kidney graft function at month 3
时间窗: 3 months
Kidney graft function is measured as estimated glomerular filtration in ml/s/1.73m2.
次要结局
- Delayed graft function(1 week)
- Gene expression in 3-month protocol biopsy of recipient(3 months)
- Urinary biomarkers of AKI in donors before organ taking (NAG)(3 months)
- Urinary biomarkers of AKI in donors before organ taking (alfa1 microglobulin)(3 months)
- Urinary biomarkers of AKI in donors before organ taking (transferrin)(3 months)
- Kidney graft survival(1 year)
- Fibrosis grade at month 3(3 months)
- Gene expression in Donor kidney(3 months)
- Urinary biomarkers of AKI in donors before organ taking (beta 2 microglobulin)(3 months)
- Urinary biomarkers of AKI in donors before organ taking(3 months)
- Urinary biomarkers of AKI in donors before organ taking (alfa2 macroglobulin)(3 months)
研究者
Prof. Ondřej Viklický, M.D., Ph.D.
Head of Department of Nephrology and Transplant Center
Institute for Clinical and Experimental Medicine