跳至主要内容
临床试验/NCT04029402
NCT04029402招募中不适用

Molecular Analysis of Diabetic Kidney Disease Biopsies

Unity Health Toronto4 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
4
主要终点
Renal function change

研究概览

简要总结

Despite decades of research, the pathogenesis of human diabetic kidney disease remains largely unclear. Our goal is to use archived human kidney biopsy tissue from patients with and with diabetic nephropathy to identify new molecules that drive and/or protect against disease progression. We will use RNA sequencing to identify transcriptomic changes that associate with histologic and functional outcomes.

详细描述

RESEARCH OBJECTIVES A. To identify differences in transcription profiles obtained from residual kidney tissue which was obtained for clinical purposes.

B. To identify differences in transcription profile between patients whose loss of kidney function progresses rapidly (eGFR decline ≥4ml/min/year) and in whom it progresses more slowly (eGFR decline <4ml/min/year).

C. To identify differences in transcription profile between predominantly glomerular and predominantly tubulointerstitial histopathological types .

D. To identify new pathogenetic pathways that may become targets for therapeutic intervention

METHODS The planned study centres on the use of archival biopsy material that is superfluous to what is or would be needed for clinical care (01/01/1995 to 31/05/2018 , n= approximately 400-500). Archived samples will be collected from St. Michael's Hospital and a number of collaborating centres, including but not limited to University of British Columbia, the University of Manitoba, and the University of Ottawa.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Renal function change

时间窗: Baseline biopsy

Slope of eGFR decline

Interstitial fibrosis

时间窗: Baseline biopsy

Extent of interstitial fibrosis in kidney biopsy assessed using a semi-quantitative scale on light microscopy of biopsy sections

Glomerulosclerosis

时间窗: Baseline biopsy

Extent of glomerulosclerosis in kidney biopsy assessed using a semi-quantitative scale on light microscopy of biopsy sections

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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