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Associating Renal Transplantation With the ITN Signature of Tolerance (ARTIST)

An Observational Study to Assess the Prevalence of a Tolerance Signature in Renal Transplant Recipients (ITN524ST/CTOT-12)

This is an observational study for people who have received a kidney transplant within the past 1 to 5 years. Researchers in this study are looking for a certain pattern of genes and cells in the blood that has been found in a group of rare transplant patients who do not need immunosuppression. The study goal is to find out how common this pattern is in transplant patients, as a first step in determining if it can be used to personalize anti-rejection drug regimens better.

研究概览

地位

完全的

条件

详细说明

Following surgery, kidney transplant patients must take medications in order to prevent rejection of their transplanted organ. These medications can be very effective. Called immunosuppressive drugs, they work by reducing the activity of the immune system. Because of this, however, they can also have serious side effects, including increased risks of serious infections and certain types of cancer.

The ITN Registry of Tolerant Kidney Transplant Recipients recently identified a rare group of people whose immune system has accepted their transplant without continued use of immunosuppressive drugs. Researchers have found that these patients have a unique pattern of cells and genes expressed in their blood compared to other transplant patients.

The ARTIST study will ask the questions "Are there other transplant patients who show this pattern?" and "If so, how often?"

The goal is to find out if there are other transplant patients who are taking immunosuppression who also show this pattern of genes. If there are others, then this pattern may one day be useful in identifying transplant patients who could reduce the dose of immunosuppression they need without fear of rejection.

Researchers are seeking adults who have received a kidney transplant within the past 1 to 5 years. Participants will be asked to attend 3 short appointments with study doctors over a period of 2 years. At these visits, doctors will request demographic and clinical information, relevant medical histories and blood and urine samples. Participants will be compensated for their time.

It is important to note that this is an observational study only. Other than receiving consultations and advice from the transplant team, there is no direct medical benefit to participating. However, by participating, patients may play an active part in helping doctors learn to control kidney transplant rejection more effectively, with fewer drugs.

研究类型

观察性的

注册 (实际的)

250

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

    • Alabama
      • Birmingham、Alabama、美国、35294
        • University of Alabama Birmingham
    • California
      • San Francisco、California、美国、94143
        • University of California San Francisco
    • Georgia
      • Atlanta、Georgia、美国、30322
        • Emory University
    • Illinois
      • Chicago、Illinois、美国、60611
        • Northwestern University
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Brigham and Women's Hospital
      • Boston、Massachusetts、美国、02115
        • Beth Israel Deaconess Medical Center
    • New York
      • New York、New York、美国、10029
        • Mount Sinai School of Medicine
    • Ohio
      • Cleveland、Ohio、美国、44195
        • The Cleveland Clinic Foundation

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 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study will include 250 participants who are determined to be eligible for further follow-up based on the eligibility criteria.

Among those eligible for further follow-up

  • at least 25 participants will be renal transplant recipients who received induction therapy with Campath, and
  • at least 25 participants will be renal transplant recipients who are receiving sirolimus or everolimus at time of enrollment and who have not received calcineurin inhibitors for at least 30 days prior to enrollment

描述

Inclusion Criteria:

  • Received first kidney transplant from a living or deceased donor.
  • Kidney transplanted between 1 and 5 years ago.
  • Calculated GFR of greater than or equal to 45 mL/min/1.73 m2 within last 6 months
  • Ability to understand and provide informed consent.

Exclusion Criteria:

  • History of steroid-resistant acute rejection
  • History of two or more episodes of acute rejection
  • Any acute rejection in the past year
  • Current malignancy
  • Transplant of another organ
  • AIDS according to the CDC definition of AIDS.

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

队列和干预

团体/队列
Renal Transplant Recipients
Subjects who received a kidney transplant within the past 1 to 5 years

研究衡量的是什么?

主要结果指标

结果测量
大体时间
The presence of at least one time point of the previously identified renal transplant tolerance signature.
大体时间:2 years
2 years

次要结果测量

结果测量
大体时间
Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants.
大体时间:2 years
2 years
Expression levels for a wide variety of genes measured by large-scale microarray or by PCR assessments
大体时间:2 years
2 years
Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype
大体时间:2 years
2 years
Selected clinical events and laboratory parameters to assess hematologic and renal function
大体时间:2 years
2 years

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。

调查人员

  • 学习椅:Kenneth Newell, MD, PhD、Emory University
  • 学习椅:Laurence Turka, MD、Beth Israel Deaconess Medical Center

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。

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

2010年9月1日

初级完成 (实际的)

2014年4月1日

研究完成 (实际的)

2014年4月1日

研究注册日期

首次提交

2012年1月19日

首先提交符合 QC 标准的

2012年1月19日

首次发布 (估计)

2012年1月24日

研究记录更新

最后更新发布 (估计)

2016年12月20日

上次提交的符合 QC 标准的更新

2016年12月16日

最后验证

2016年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • DAIT ITN524ST/CTOT-12

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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