Australian Genomics Of Chronic Allograft Dysfunction Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Kidney Transplant Rejection, Kidney Transplant; Complications. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Graft failure [Time frame: Time Frame: At biopsy or during study follow up after biopsy (expected average 60-months)]
- Allograft rejection [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
- Gene profile [Time frame: At biopsy - based on collected tissue sample]
Secondary outcome measures (11)
- Death [Time frame: At biopsy or during study follow up after biopsy (expected average over 60-months)]
- Major infectious adverse outcomes [Time frame: Any time (expected average over 12-months)]
- Major malignancy related adverse outcomes [Time frame: Any time (expected average over 12-months)]
- Major cardiovascular adverse outcomes [Time frame: Any time (expected average over 12-months)]
- Chronic allograft dysfunction [Time frame: Any time (expected average 60-months)]
- BK virus associated nephropathy [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
- Albuminuria [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
- Surrogate end-points [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
- Delayed graft function (DGF) [Time frame: At biopsy or during study follow up after biopsy (within 7 days of transplantation)]
- Death censored graft loss (DCGL) [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
- Treatment resistant rejection [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Australia · 2 centers
- Westmead Hospital — Westmead
- Westmead Institute for Medical Research — Westmead
Identifiers
NCT: NCT06314230 · AUSCAD