Australian Genomics Of Chronic Allograft Dysfunction Study
- Conditions
- Kidney Transplant RejectionKidney Transplant; Complications
- Registration Number
- NCT06314230
- Lead Sponsor
- Western Sydney Local Health District
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Death At biopsy or during study follow up after biopsy (expected average over 60-months) Death from any cause
Major infectious adverse outcomes Any time (expected average over 12-months) Major viral, bacterial or fungal infections
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)
Albuminuria At biopsy or during study follow up after biopsy (expected average 12-months) Based on urine albumin to creatinine ratio
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
Major malignancy related adverse outcomes Any time (expected average over 12-months) Major cancers - particularly virally driven malignancies, skin cancers
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)
Surrogate end-points At biopsy or during study follow up after biopsy (expected average 12-months) eGFR slow and iBOX score
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
Trial Locations
- Locations (2)
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Westmead Institute for Medical Research
🇦🇺Westmead, New South Wales, Australia