Genomics of Kidney Transplantation
The major aim of this research study is to investigate the relationship between genetic variation in DNA (inherited code material in the cells of the body) and factors affecting transplant outcomes, like the drugs people receive or the way their immune systems work, for example.
To do this, investigators will collect blood samples from participants.
Genetic material will be separated from each blood sample and analyzed, looking for genetic variation.
研究概览
详细说明
In the past, the major problems in kidney transplantation were surgical complications, acute rejection, and infections. Right now, researchers are focusing on improving immune suppression therapy and achieving better long-term survival of kidney transplants. One of the ways to try to understand what causes loss of function after many years is to find out if there is a genetic factor involved.
There are a number of differences in specific genes that have been identified and are thought to affect transplant outcomes. Studying these gene variations (differences between people or differences between populations) is important in determining whether these variations are related to transplant outcomes and how this information can help patients achieve better long-term transplant survival.
研究类型
观察性的
注册 (实际的)
1552
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。
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
- 孩子
- 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
非概率样本
研究人群
Targeted: 3000 Kidney or Kidney-pancreas transplant recipients and 1300 of the donors
描述
Inclusion Criteria:
- Kidney (or kidney-pancreas) transplant recipient no more than 10 days post-transplant or kidney donor no more than 30 days post-transplant or previously enrolled in Phase I of the Genomics of Kidney Transplantation Study;
- No organs other than kidney or pancreas transplanted simultaneously with the qualifying kidney transplant; and
- Participant or parent/guardian must be able to understand and provide written informed consent.
Inclusion for the Activity and mRNA Expression Cohort:
- Recipient enrolled in the Main Cohort Study;
- Informed consent for participation in the Activity and mRNA Expression Cohort;
- Age 18 years or greater as of day of transplantation;and
- Will receive tacrolimus, cyclosporine or mycophenolate as part of maintenance immunosuppression therapy.
Exclusion Criteria:
- Inability or unwillingness of the participant or parent/guardian to give a written informed consent or comply with the study protocol.
For the Activity and mRNA Expression Cohort:
- Inability or unwillingness of the participant or parent/guardian to give a written informed consent for participation in the Activity and mRNA Expression Cohort or comply with the study protocol.
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 |
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Transplant Recipients Cohort
Main Study Cohort: Kidney (or kidney-pancreas) transplant recipients.
Enrollment for this cohort is closed.
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Transplant Donors Cohort
Main Study Cohort: The kidney donor for transplant recipients in this study.
Enrollment for this cohort is closed.
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Activity&mRNA Expression Substudy Cohort
A subset of subjects enrolled in the main study who will receive tacrolimus, cyclosporine or mycophenolate as part of maintenance immunosuppression therapy.
This group has a prospective observational cohort design.
Enrollment into the Activity and messenger ribonucleic acid (mRNA) Expression Cohort, occurring concurrently with enrollment of the rest of the study, will continue until either the required sample size of 600 is achieved or the protocol team terminates enrollment.
Participants in the Activity and mRNA Expression Cohort have additional blood draws up to 2 weeks prior to transplant, at week 1, Month 3 and Month 6 post-transplant.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Transplant recipient genotypes: time to chronic graft disfunction
大体时间：Day 0 to Year 5
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Day 0 to Year 5
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Transplant recipient genotypes: time to a persistent 25% decrease in Estimated Glomerular Filtration Rate (eGFR)
大体时间：Day 0 to Year 5
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eGFR: Estimated GFR test results are a measure of kidney function.
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Day 0 to Year 5
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Transplant recipient genotypes: time to acute rejection
大体时间：Day 0 to Year 5
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Day 0 to Year 5
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Transplant recipient genotypes: time to allograft failure
大体时间：Day 0 to Year 5
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allograft failure is defined as graft loss or participant death.
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Day 0 to Year 5
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Donor Genotypes: time to chronic graft dysfunction
大体时间：Day 0 to Year 5
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The time to dysfunction of the donated organ.
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Day 0 to Year 5
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Donor Genotypes: time to a persistent 25% decrease in eGFR
大体时间：Day 0 to year 5
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The time to a persistent 25% decrease in eGFR in the donated organ's recipient.
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Day 0 to year 5
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Donor Genotypes: time to allograft failure
大体时间：Day 0 to Year 5
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The time to the failure of the donated organ (defined as graft loss or participant death).
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Day 0 to Year 5
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Recipient genotypes: time to select mycophenolate-related toxicities (leukopenia, anemia)
大体时间：Day 0 to Year 5
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Day 0 to Year 5
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Recipient genotypes: time to select Calcineurin Inhibitor (CNI)-related toxicities
大体时间：Day 0 to Year 5
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Toxicities may include: new onset diabetes or nephrotoxicity.
CNI: calcineurin inhibitor
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Day 0 to Year 5
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Recipient genotypes: repeated measures of clinically obtained tacrolimus trough blood levels
大体时间：Day 0 to Year 5
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Day 0 to Year 5
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Recipient candidate genotypes: Calcineurin (CN) and IMPDH protein activity and expression
大体时间：Day 0 to Year 5
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CN: Calcineurin.
IMPDH: Inosine-5'-monophosphate dehydrogenase
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Day 0 to Year 5
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to composite endpoint of graft loss or death or persistent 25% increase in serum creatinine
大体时间：Day 0 to Year 5
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Day 0 to Year 5
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Time to renal biopsy with presence of the following semi-quantitative pathology endpoints: patterns of Banff biopsy score, presence of circulating anti-donor anti-Human Leukocyte Antigen (HLA) antibodies, C4d positivity
大体时间：Day 0 to Year 5
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Day 0 to Year 5
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Slope of eGFR
大体时间：Day 0 to Year 5
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Day 0 to Year 5
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Delayed graft function
大体时间：Day 0 to Year 5
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Day 0 to Year 5
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Time to Epstein-Barr virus (EBV) and Cytomegalovirus (CMV) infection
大体时间：Day 0 to Year 5
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EBV: Epstein-Barr virus.
CMV: cytomegalovirus.
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Day 0 to Year 5
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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
- 首席研究员：A Matas, MD、University of Minnesota
- 学习椅：A Israni, MD, MS、University of Minnesota
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
- Oetting WS, Schladt DP, Dorr CR, Wu B, Guan W, Remmel RP, Ikle D, Mannon RB, Matas AJ, Israni AK, Jacobson PA; DeKAF Genomics and GEN03 Investigators. Analysis of 75 Candidate SNPs Associated With Acute Rejection in Kidney Transplant Recipients: Validation of rs2910164 in MicroRNA MIR146A. Transplantation. 2019 Aug;103(8):1591-1602. doi: 10.1097/TP.0000000000002659.
- Nguyen TT, Pearson RA, Mohamed ME, Schladt DP, Berglund D, Rivers Z, Skaar DJ, Wu B, Guan W, van Setten J, Keating BJ, Dorr C, Remmel RP, Matas AJ, Mannon RB, Israni AK, Oetting WS, Jacobson PA. Pharmacogenomics in kidney transplant recipients and potential for integration into practice. J Clin Pharm Ther. 2020 Dec;45(6):1457-1465. doi: 10.1111/jcpt.13223. Epub 2020 Jul 14.
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
2012年8月1日
初级完成 (实际的)
2017年1月1日
研究完成 (实际的)
2017年1月1日
研究注册日期
首次提交
2012年10月17日
首先提交符合 QC 标准的
2012年10月25日
首次发布 (估计)
2012年10月26日
研究记录更新
最后更新发布 (实际的)
2017年6月5日
上次提交的符合 QC 标准的更新
2017年6月2日
最后验证
2017年6月1日
更多信息
与本研究相关的术语
其他研究编号
- DAIT GEN-03
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.