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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kidney transplant recipients | Kidney or kidney-pancreas transplant recipients enrolled into the study prospectively. Risk factors recorded, blood/urine/kidney samples analysed and correlated with outcomes. Non-interventional, observational in nature. |
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| Measure | Description | Time Frame |
|---|---|---|
| Graft failure | Failure of the kidney transplant, resulting in death or return to dialysis | Time Frame: At biopsy or during study follow up after biopsy (expected average 60-months) |
| Allograft rejection | Any rejection (acute or chronic, borderline, T-cell, antibody or mixed rejection) in the kidney transplant | At biopsy or during study follow up after biopsy (expected average 12-months) |
| Gene profile | Gene expression or variant profiles of participants | At biopsy - based on collected tissue sample |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Death from any cause | At biopsy or during study follow up after biopsy (expected average over 60-months) |
| Major infectious adverse outcomes | Major viral, bacterial or fungal infections |
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Inclusion Criteria:
Exclusion Criteria:
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Adult, kidney transplant recipients who receive a transplant at Westmead Hospital are eligible for enrolment if they meet the above inclusion/exclusion criteria. They patients can receive a kidney transplant from either kidney-only or kidney-pancreas transplant. They may receive a kidney from either living or deceased donor. Participants are formally enrolled after informed consent and if the transplant proceeds. Participants are allowed to withdraw from the study at any time.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer SY Li, MBBS, FRACP | Contact | jennifer.li@health.nsw.gov.au | ||
| Philip J O'Connell, MBBS, FRACP | Contact | philip.oconnell@sydney.edu.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmead Hospital | Recruiting | Westmead | New South Wales | 2145 | Australia |
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Enrolment is allocated time 0 (baseline). At times 0, 1, 3, 6, 12, 18 and 24 months, patients will be asked to provide blood and urine samples. At time 0, 3, 12 and indication biopsies, a core kidney biopsy if this already being performed as part of clinical care. These samples will biobanked and used to answer the primary questions of this study and consent will be obtained for samples to be used in future research in to renal related disorders.
After 24months, only medical records will be reviewed in the majority of patients, collecting key outcome measures of kidney function, rejection, major complications or allograft failure (resulting in death or return to dialysis). Patients are invited to participate in the extended follow up phase (after 24months)- where patients may choose to submit blood/urine/tissue samples if an indication biopsy performed as part of their clinical care.
| Any time (expected average over 12-months) |
| Major malignancy related adverse outcomes | Major cancers - particularly virally driven malignancies, skin cancers | Any time (expected average over 12-months) |
| Major cardiovascular adverse outcomes | 4-point MACE: CV death, non-fatal MI, non-fatal stroke, UA requiring hospitalization; and cardiometabolic risks (post-transplant diabetes, dyslipidemia, obesity) | Any time (expected average over 12-months) |
| Chronic allograft dysfunction | Decline in kidney function in the transplant from the baseline, histologically manifest as fibrosis (interstitial fibrosis and tubular atrophy, IFTA) | Any time (expected average 60-months) |
| BK virus associated nephropathy | BK virus associated nephropathy biopsy evidence of positive SV40 stain in tubules | At biopsy or during study follow up after biopsy (expected average 12-months) |
| Albuminuria | Based on urine albumin to creatinine ratio | At biopsy or during study follow up after biopsy (expected average 12-months) |
| Surrogate end-points | eGFR slow and iBOX score | At biopsy or during study follow up after biopsy (expected average 12-months) |
| Delayed graft function (DGF) | Need for dialysis within 7 days of transplantation | At biopsy or during study follow up after biopsy (within 7 days of transplantation) |
| Death censored graft loss (DCGL) | Graft loss - excluding cases of death with functioning graft | At biopsy or during study follow up after biopsy (expected average 12-months) |
| Treatment resistant rejection | Persistent rejection despite additional glucocorticoids and/or upscaling of maintenance immunosuppression | At biopsy or during study follow up after biopsy (expected average 12-months) |
| Westmead Institute for Medical Research | Recruiting | Westmead | New South Wales | 2145 | Australia |
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