Clinical trial NCT06314230: Australian Genomics Of Chronic Allograft Dysfunction Study
Official title: Australian Genomics Of Chronic Allograft Dysfunction Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplant Rejection
Kidney Transplant; Complications
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

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.


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.

Primary outcomes:
measure: Graft failure
timeFrame: Time Frame: At biopsy or during study follow up after biopsy (expected average 60-months)
measure: Allograft rejection
timeFrame: At biopsy or during study follow up after biopsy (expected average 12-months)
measure: Gene profile
timeFrame: At biopsy - based on collected tissue sample
Secondary outcomes:
measure: Death
timeFrame: At biopsy or during study follow up after biopsy (expected average over 60-months)
measure: Major infectious adverse outcomes
timeFrame: Any time (expected average over 12-months)
measure: Major malignancy related adverse outcomes
timeFrame: Any time (expected average over 12-months)
measure: Major cardiovascular adverse outcomes
timeFrame: Any time (expected average over 12-months)
measure: Chronic allograft dysfunction
timeFrame: Any time (expected average 60-months)
measure: BK virus associated nephropathy
timeFrame: At biopsy or during study follow up after biopsy (expected average 12-months)
measure: Albuminuria
timeFrame: At biopsy or during study follow up after biopsy (expected average 12-months)
measure: Surrogate end-points
timeFrame: At biopsy or during study follow up after biopsy (expected average 12-months)
measure: Delayed graft function (DGF)
timeFrame: At biopsy or during study follow up after biopsy (within 7 days of transplantation)
measure: Death censored graft loss (DCGL)
timeFrame: At biopsy or during study follow up after biopsy (expected average 12-months)
measure: Treatment resistant rejection
timeFrame: At biopsy or during study follow up after biopsy (expected average 12-months)
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Institute for Medical Research
state: New South Wales
Study officials:
References: