Australian Genomics Of Chronic Allograft Dysfunction Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Graft failure
研究概览
简要总结
The goal of the Australian Genomics of Chronic Allograft Dysfunction (AUSCAD) study is a single centre (Westmead Hospital), prospective, observational study, which enrols patients at time of kidney (or kidney-transplant) transplant and tracks the post transplant course. The AUSCAD study aims to generate new knowledge and improve outcomes following kidney transplantation. The primary aim is to determine whether important outcomes (including chronic rejection and graft loss) are correlated with patterns of allograft reactivity, gene expression and susceptibility profiles.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Living or deceased donor kidney transplant candidate.
- •Biological sex: any
- •Ages: 18-75 years.
- •Subject must be able to understand and provide informed consent.
- •Deceased donor individuals where Research Consent has been obtained from the person consenting to organ donation at the time of organ retrieval.
- •Identifiable living donors who have received informed consent and have consented to participate in the project.
排除标准
- •Presensitization in living donor recipients prior to transplantation, as determined by site-specific standards, OR positive cross match according to site specific technique in cadaveric donor recipients.
- •Recipients of multiple organ transplants, with the exception of kidney/pancreas transplants.
- •Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- •High risk populations including pregnant women, children less than 18 years and prisoners will not be included in the study.
- •Non English speaking potential participants who do not understand the requirements of the study will not be included.
结局指标
主要结局
Graft failure
时间窗: Time Frame: At biopsy or during study follow up after biopsy (expected average 60-months)
Failure of the kidney transplant, resulting in death or return to dialysis
Allograft rejection
时间窗: At biopsy or during study follow up after biopsy (expected average 12-months)
Any rejection (acute or chronic, borderline, T-cell, antibody or mixed rejection) in the kidney transplant
Gene profile
时间窗: At biopsy - based on collected tissue sample
Gene expression or variant profiles of participants
次要结局
- BK virus associated nephropathy(At biopsy or during study follow up after biopsy (expected average 12-months))
- Death(At biopsy or during study follow up after biopsy (expected average over 60-months))
- Major infectious adverse outcomes(Any time (expected average over 12-months))
- Chronic allograft dysfunction(Any time (expected average 60-months))
- Albuminuria(At biopsy or during study follow up after biopsy (expected average 12-months))
- Delayed graft function (DGF)(At biopsy or during study follow up after biopsy (within 7 days of transplantation))
- Major malignancy related adverse outcomes(Any time (expected average over 12-months))
- Major cardiovascular adverse outcomes(Any time (expected average over 12-months))
- Surrogate end-points(At biopsy or during study follow up after biopsy (expected average 12-months))
- Death censored graft loss (DCGL)(At biopsy or during study follow up after biopsy (expected average 12-months))
- Treatment resistant rejection(At biopsy or during study follow up after biopsy (expected average 12-months))
研究者
Jennifer Li
Nephrologist and Transplant Physician
Western Sydney Local Health District