Australian Genomics Of Chronic Allograft Dysfunction Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorWestern Sydney Local Health District
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Living or deceased donor kidney transplant candidate.
Biological sex: any
Ages: 18-75 years.
Subject must be able to understand and provide informed consent.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: Kidney transplant recipients
Trial outcomes
Primary outcomes
1
Graft failure
Failure of the kidney transplant, resulting in death or return to dialysis
Time frame
Time Frame: At biopsy or during study follow up after biopsy (expected average 60-months)2
Allograft rejection
Any rejection (acute or chronic, borderline, T-cell, antibody or mixed rejection) in the kidney transplant
Time frame
At biopsy or during study follow up after biopsy (expected average 12-months)3
Gene profile
Gene expression or variant profiles of participants
Time frame
At biopsy - based on collected tissue sampleSecondary outcomes
1
Death
Death from any cause
Time frame
At biopsy or during study follow up after biopsy (expected average over 60-months)2
Major infectious adverse outcomes
Major viral, bacterial or fungal infections
Time frame
Any time (expected average over 12-months)3
Major malignancy related adverse outcomes
Major cancers - particularly virally driven malignancies, skin cancers
Time frame
Any time (expected average over 12-months)4
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)
Time frame
Any time (expected average over 12-months)Sponsors and contacts
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Source ClinicalTrials.gov