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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06314230




Registration number
NCT06314230
Ethics application status
Date submitted
10/03/2024
Date registered
15/03/2024
Date last updated
10/04/2024

Titles & IDs
Public title
Australian Genomics Of Chronic Allograft Dysfunction Study
Scientific title
Australian Genomics Of Chronic Allograft Dysfunction Study
Secondary ID [1] 0 0
AUSCAD
Universal Trial Number (UTN)
Trial acronym
AUSCAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplant Rejection 0 0
Kidney Transplant; Complications 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Kidney transplant recipients - Kidney or kidney-pancreas transplant recipients enrolled into the study prospectively. Risk factors recorded, blood/urine/kidney samples analysed and correlated with outcomes.
Non-interventional, observational in nature.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Graft failure
Timepoint [1] 0 0
Time Frame: At biopsy or during study follow up after biopsy (expected average 60-months)
Primary outcome [2] 0 0
Allograft rejection
Timepoint [2] 0 0
At biopsy or during study follow up after biopsy (expected average 12-months)
Primary outcome [3] 0 0
Gene profile
Timepoint [3] 0 0
At biopsy - based on collected tissue sample
Secondary outcome [1] 0 0
Death
Timepoint [1] 0 0
At biopsy or during study follow up after biopsy (expected average over 60-months)
Secondary outcome [2] 0 0
Major infectious adverse outcomes
Timepoint [2] 0 0
Any time (expected average over 12-months)
Secondary outcome [3] 0 0
Major malignancy related adverse outcomes
Timepoint [3] 0 0
Any time (expected average over 12-months)
Secondary outcome [4] 0 0
Major cardiovascular adverse outcomes
Timepoint [4] 0 0
Any time (expected average over 12-months)
Secondary outcome [5] 0 0
Chronic allograft dysfunction
Timepoint [5] 0 0
Any time (expected average 60-months)
Secondary outcome [6] 0 0
BK virus associated nephropathy
Timepoint [6] 0 0
At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary outcome [7] 0 0
Albuminuria
Timepoint [7] 0 0
At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary outcome [8] 0 0
Surrogate end-points
Timepoint [8] 0 0
At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary outcome [9] 0 0
Delayed graft function (DGF)
Timepoint [9] 0 0
At biopsy or during study follow up after biopsy (within 7 days of transplantation)
Secondary outcome [10] 0 0
Death censored graft loss (DCGL)
Timepoint [10] 0 0
At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary outcome [11] 0 0
Treatment resistant rejection
Timepoint [11] 0 0
At biopsy or during study follow up after biopsy (expected average 12-months)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2040
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Westmead Institute for Medical Research - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06314230
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jennifer SY Li, MBBS, FRACP
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
jennifer.li@health.nsw.gov.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06314230