Kidney Transplant; Complications, Kidney Transplant Rejection
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Western Sydney Local Health District
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft failure | 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 | 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 | At biopsy - based on collected tissue sample | Gene expression or variant profiles of participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major cardiovascular adverse outcomes | Any time (expected average over 12-months) | 4-point MACE: CV death, non-fatal MI, non-fatal stroke, UA requiring hospitalization; and cardiometabolic risks (post-transplant diabetes, dyslipidemia, obesity) |
| Chronic allograft dysfunction | Any time (expected average 60-months) | Decline in kidney function in the transplant from the baseline, histologically manifest as fibrosis (interstitial fibrosis and tubular atrophy, IFTA) |
| BK virus associated nephropathy | At biopsy or during study follow up after biopsy (expected average 12-months) | BK virus associated nephropathy biopsy evidence of positive SV40 stain in tubules |
| Albuminuria | At biopsy or during study follow up after biopsy (expected average 12-months) | Based on urine albumin to creatinine ratio |
| Death | At biopsy or during study follow up after biopsy (expected average over 60-months) | Death from any cause |
| Delayed graft function (DGF) | At biopsy or during study follow up after biopsy (within 7 days of transplantation) | Need for dialysis within 7 days of transplantation |
| Death censored graft loss (DCGL) | At biopsy or during study follow up after biopsy (expected average 12-months) | Graft loss - excluding cases of death with functioning graft |
| Treatment resistant rejection | At biopsy or during study follow up after biopsy (expected average 12-months) | Persistent rejection despite additional glucocorticoids and/or upscaling of maintenance immunosuppression |
| Surrogate end-points | At biopsy or during study follow up after biopsy (expected average 12-months) | eGFR slow and iBOX score |
| Major infectious adverse outcomes | Any time (expected average over 12-months) | Major viral, bacterial or fungal infections |
| Major malignancy related adverse outcomes | Any time (expected average over 12-months) | Major cancers - particularly virally driven malignancies, skin cancers |
Countries
Australia
Contacts
Primary ContactJennifer SY Li, MBBS, FRACP
Backup ContactPhilip J O'Connell, MBBS, FRACP
Outcome results
None listed