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Proteogenomic Biomarker Panels in a Serial Blood & Urine Monitoring Study of Kidney Transplant Recipients (PROGENI-KI)

2017年8月10日更新者：National Institute of Allergy and Infectious Diseases (NIAID)

Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood & Urine Monitoring Study of Kidney Transplant Recipients - Transplant Proteogenomics

There is a need to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had kidney transplant. Researchers will examine blood, urine, and tissue samples and try to identify genetic markers for certain conditions like rejection, response to therapy, and scarring of the kidney. By studying gene patterns, researchers hope to be able to diagnose these conditions earlier and improve kidney survival.

研究概览

地位

完全的

条件

详细说明

Kidney transplantation is a good treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it working for a long time. One field of interest is how one's cellular make-up might affect the body's immune response (body's natural defense system to illness and foreign things) to a kidney transplant. Cellular tests, like gene expression, help doctors to study a person's cellular traits. Gene expression is when information found in one's DNA is translated into RNA and eventually proteins. These components are present in each of the body's cells. In this study, researchers are trying to learn if certain changes in the RNA and proteins found in blood, urine, or transplant biopsy tissue can detect rejection before injury can occur or become too severe. The blood and urine tests will look for patterns in one's DNA (called genetic markers).

This study will follow subjects for 2 years after transplant. There will be a total of 12 study visits with additional study visits if rejection occurs. The study requires additional samples of blood, urine, and tissue to be collected during routine clinical visits and biopsies (a procedure to remove and examine a small piece of kidney tissue).

研究类型

观察性的

注册 (实际的)

307

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Arizona
  - Phoenix、Arizona、美国、85054
    - Mayo Clinic, Division of Nephrology
- California
  - La Jolla、California、美国、92037
    - The Scripps Research Institute, Scripps Center for Organ and Cell Transplantation,
- Illinois
  - Chicago、Illinois、美国、60611
    - Northwestern University, Feinberg School of Medicine, Division of Organ Transplantation
- Ohio
  - Cleveland、Ohio、美国、44195
    - The Cleveland Clinic
- South Carolina
  - Charleston、South Carolina、美国、29425
    - Medical University of South Carolina, Division of Transplant

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Adults undergoing kidney transplantation.

描述

Inclusion Criteria:

Subjects undergoing primary or subsequent deceased-donor or living donor kidney transplantation
Subject and/or parent guardian must be able to understand and provide informed consent
Female subjects of childbearing potential must have a negative pregnancy test within 6 weeks of study entry.

Exclusion Criteria:

Need for combined organ transplantation with an extra-renal organ and/or islet
Recipient of previous non-renal solid organ and/or islet cell transplantation
Infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
Inability or unwillingness of a participant to give written informed consent or comply with study protocol
Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：队列
时间观点：预期

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Incidence of Biopsy Proven Acute Rejection (AR)-Clinical and Sub-Clinical), Chronic Allograft Nephropathy/Interstitial Fibrosis and Tubular Atrophy (CAN/IFTA), and Normal Renal Biopsy with Stable, Good Kidney Function 大体时间：12 and 24 months	12 and 24 months

次要结果测量

结果测量	大体时间
Incidence of Death 大体时间：Baseline to month 24	Baseline to month 24
Incidence of Graft Loss 大体时间：Baseline to month 24	Baseline to month 24
Incidence of Opportunistic infections 大体时间：Baseline to month 24	Baseline to month 24
Incidence of BKV, CMV, and EBV Infection 大体时间：Baseline to month 24	Baseline to month 24
Incidence of Treated Urinary Tract Infection 大体时间：Baseline to month 24	Baseline to month 24
Incidence of Malignancy 大体时间：Baseline to month 24	Baseline to month 24
Changes that Occur in Blood, Urine, and Kidney Tissue Gene Expression Signature 大体时间：Month 1 to month 24	Month 1 to month 24
Changes in Plasma Protein Expression Profile 大体时间：Month 1 to month 24	Month 1 to month 24
Changes in Urine Protein Expression Profile 大体时间：Month 1 to month 24	Month 1 to month 24
Changes in Blood MicroRNA Expression Profile 大体时间：Month 1 to month 24	Month 1 to month 24
Evolution of Gene and Protein Expression Profiles During Response to Therapy for AR 大体时间：Month 1 to month 24	Month 1 to month 24
Evolution of Gene and Protein Expression Profiles During Progression or Regression of CAN/IFTA on Protocol Biopsies 大体时间：Month 1 to month 24	Month 1 to month 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Institute of Allergy and Infectious Diseases (NIAID)

合作者

Clinical Trials in Organ Transplantation

调查人员

首席研究员：Michael Abecassis, MD, MBA、Northwestern University
学习椅：John J Friedewald, MD、Northwestern University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年3月1日

初级完成 (实际的)

2016年6月1日

研究完成 (实际的)