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临床试验/NCT00805571
NCT00805571已完成不适用

Urinary Kidney Injury Molecule-1 As Diagnostic Biomarker of Proximal Tubular Injury in Adult and Pediatric Transplant Recipients

Northwell Health1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1

研究概览

简要总结

The purpose of this study is to determine if measuring the level of a protein called Kidney Injury Molecule-1 (KIM-1) in the urine will help healthcare providers detect any problems with the transplanted kidney before the laboratory investigations that are used on a routine basis do. This approach may allow the doctor to intervene at an earlier point of a rejection episode and may thereby prolong survival of the transplant kidney.

详细描述

SPECIFIC AIMS:

  1. To investigate the role of urinary Kim-1 excretion as a marker of delayed graft function, acute kidney allograft rejection and/or virus-induced allograft nephropathy and/or calcineurin-inhibitor nephrotoxicity.
  2. To determine the role of urinary Kim-1 excretion in predicting long term outcome after kidney transplantation compared to standard diagnostic tests.
  3. To determine the role of reduction in urinary Kim-1 excretion after a rejection episode and/or viral infection as a marker of repair of renal tubules.

HYPOTHESIS

Monitoring of urinary KIM-1 in kidney transplant recipients will facilitate the detection of delayed graft function, acute allograft rejection or infectious causes of proximal tubular injury, allowing earlier intervention with better long-term graft survival. Detection of urinary KIM-1 will precede increases in serum creatinine to detect acute graft injury and urinary KIM-1 will decrease faster than serum creatinine and will predict responsiveness (or lack thereof) to intervention more accurately.

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
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children and adults from the age of 3 years who are eligible transplant candidates listed for deceased donor kidney or who are scheduled for a living related or unrelated donor kidney transplant at Mount Sinai Hospital will be eligible for inclusion in this project. Patients will be recruited from the population awaiting kidney transplant treated at the Schneider Children's Hospital and Mount Sinai Hospital.

排除标准

  • 未提供

研究者

申办方类型
Other

研究点 (1)

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