NCT06365411尚未招募不适用
GEnomic Medicine in Kidney Transplantation Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Death censored graft loss (DCGL)
研究概览
简要总结
Investigator led, prospective, observational cohort study to detect genomic features which can predict outcomes following kidney transplantation.
- Determine non-HLA genomic mismatches between donor-recipient pairs which impact kidney allograft survival following transplantation
- Derive polygenic risk scores on pre-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction
- Derive polygenic risk scores on post-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants included in the study must be age ≥ 18 years old at time of enrolment and
- •able to provide informed consent (interpreter permitted) for enrolment
- •consenting to longitudinal follow up (can withdraw post enrolment)
- •consenting to provide samples for biobanking, including blood, urine, faecal and/or kidney biopsy tissue (collected prospectively, separate to routine care)
排除标准
- •Patients will be excluded from the study if they are
- •unable (or unwilling) to provide consent, or
- •have life-expectancy less than 6-months, or
- •have received a haematopoietic stem cell transplant in the past 5 years.
结局指标
主要结局
Death censored graft loss (DCGL)
时间窗: At biopsy or during study follow up after biopsy (expected average over 60-months)
Loss of functioning kidney transplant (not counted if patient died with functioning graft)
Biopsy proven rejection (BPAR)
时间窗: At biopsy or during study follow up after biopsy (expected average 12-months)
Rejection diagnosed on kidney transplant biopsy
次要结局
- Albuminuria(Months 1, 3, 12 any time after 12-months trnasplantation)
- Death(Any time during or after biopsy (expected over 60-months))
- Delayed Graft Function (DGF)(within the first 7 days post transplantation)
- chronic rejection; chronic transplant glomerulopathy; and interstitial fibrosis and tubular atrophy (IFTA) scores(At biopsy or during study follow up after biopsy (expected average over 12-months))
- Major cardiovascular complications(At biopsy or during study follow up after biopsy (expected average 60-months))
- Kidney cell type composition(At biopsy - based on collected tissue sample)
- Proteinomic signature(At biopsy or during study follow up after biopsy (expected average 12-months))
- Hospital admission or emergency attendance(At biopsy or during study follow up after biopsy (expected average 12-months))
- Kidney function(Months 1, 3, 12, 24, 36, 48, 60, 120 post transplantation)
- BK virus complications(At biopsy or during study follow up after biopsy (expected average 12-months))
- Kidney biopsy transcriptomic signature(At biopsy - based on collected tissue sample)
- All cause graft loss(At biopsy or during study follow up after biopsy (expected average over 60-months))
- Treatment resistant rejection(At biopsy or during study follow up after biopsy (expected average 12-months))
- Surrogate end-point markers(Months 3, 12, 24, 36, 48 and 60, 120 post transplantation)
- Borderline rejeciton(At biopsy or during study follow up after biopsy (expected average 12-months))
- Major infectious complications(At biopsy or during study follow up after biopsy (expected average 60-months))
- Malignancy post transplantation(At biopsy or during study follow up after biopsy (expected average 60-months))
- Recurrent disease(At biopsy or during study follow up after biopsy (expected average 60-months))
研究者
Jennifer Li
Nephrologist and Transplant Physician
Western Sydney Local Health District
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