Genomics of Kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,552
- 试验地点
- 5
- 主要终点
- Transplant recipient genotypes: time to a persistent 25% decrease in Estimated Glomerular Filtration Rate (eGFR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Transplant recipient genotypes: time to a persistent 25% decrease in Estimated Glomerular Filtration Rate (eGFR)
时间窗: Day 0 to Year 5
eGFR: Estimated GFR test results are a measure of kidney function.
Recipient genotypes: time to select Calcineurin Inhibitor (CNI)-related toxicities
时间窗: Day 0 to Year 5
Toxicities may include: new onset diabetes or nephrotoxicity. CNI: calcineurin inhibitor
Transplant recipient genotypes: time to acute rejection
时间窗: Day 0 to Year 5
Transplant recipient genotypes: time to allograft failure
时间窗: Day 0 to Year 5
allograft failure is defined as graft loss or participant death.
Donor Genotypes: time to a persistent 25% decrease in eGFR
时间窗: Day 0 to year 5
The time to a persistent 25% decrease in eGFR in the donated organ's recipient.
Donor Genotypes: time to chronic graft dysfunction
时间窗: Day 0 to Year 5
The time to dysfunction of the donated organ.
Donor Genotypes: time to allograft failure
时间窗: Day 0 to Year 5
The time to the failure of the donated organ (defined as graft loss or participant death).
Recipient candidate genotypes: Calcineurin (CN) and IMPDH protein activity and expression
时间窗: Day 0 to Year 5
CN: Calcineurin. IMPDH: Inosine-5'-monophosphate dehydrogenase
Transplant recipient genotypes: time to chronic graft disfunction
时间窗: Day 0 to Year 5
Recipient genotypes: repeated measures of clinically obtained tacrolimus trough blood levels
时间窗: Day 0 to Year 5
Recipient genotypes: time to select mycophenolate-related toxicities (leukopenia, anemia)
时间窗: Day 0 to Year 5
次要结局
- 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(Day 0 to Year 5)
- Slope of eGFR(Day 0 to Year 5)
- Time to composite endpoint of graft loss or death or persistent 25% increase in serum creatinine(Day 0 to Year 5)
- Time to Epstein-Barr virus (EBV) and Cytomegalovirus (CMV) infection(Day 0 to Year 5)
- Delayed graft function(Day 0 to Year 5)