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)
研究概览
地位
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
注册 (实际的)
联系人和位置
学习地点
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama Birmingham
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California
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San Francisco、California、美国、94143
- University of California San Francisco
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern University
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Massachusetts
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Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital
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Boston、Massachusetts、美国、02115
- Beth Israel Deaconess Medical Center
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New York
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New York、New York、美国、10029
- Mount Sinai School of Medicine
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Ohio
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Cleveland、Ohio、美国、44195
- The Cleveland Clinic Foundation
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
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
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Renal Transplant Recipients
Subjects who received a kidney transplant within the past 1 to 5 years
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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The presence of at least one time point of the previously identified renal transplant tolerance signature.
大体时间:2 years
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2 years
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次要结果测量
结果测量 |
大体时间 |
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Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants.
大体时间:2 years
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2 years
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Expression levels for a wide variety of genes measured by large-scale microarray or by PCR assessments
大体时间:2 years
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2 years
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Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype
大体时间:2 years
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2 years
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Selected clinical events and laboratory parameters to assess hematologic and renal function
大体时间:2 years
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2 years
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合作者和调查者
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
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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