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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06314230
Registration number
NCT06314230
Ethics application status
Date submitted
10/03/2024
Date registered
15/03/2024
Titles & IDs
Public title
Australian Genomics Of Chronic Allograft Dysfunction Study
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Scientific title
Australian Genomics Of Chronic Allograft Dysfunction Study
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Secondary ID [1]
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AUSCAD
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Universal Trial Number (UTN)
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Trial acronym
AUSCAD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Kidney Transplant Rejection
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Kidney Transplant; Complications
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Condition category
Condition code
Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Graft failure
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Assessment method [1]
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Failure of the kidney transplant, resulting in death or return to dialysis
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Timepoint [1]
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Time Frame: At biopsy or during study follow up after biopsy (expected average 60-months)
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Primary outcome [2]
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Allograft rejection
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Assessment method [2]
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Any rejection (acute or chronic, borderline, T-cell, antibody or mixed rejection) in the kidney transplant
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Timepoint [2]
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At biopsy or during study follow up after biopsy (expected average 12-months)
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Primary outcome [3]
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Gene profile
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Assessment method [3]
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Gene expression or variant profiles of participants
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Timepoint [3]
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At biopsy - based on collected tissue sample
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Secondary outcome [1]
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Death
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Assessment method [1]
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Death from any cause
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Timepoint [1]
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At biopsy or during study follow up after biopsy (expected average over 60-months)
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Secondary outcome [2]
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Major infectious adverse outcomes
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Assessment method [2]
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Major viral, bacterial or fungal infections
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Timepoint [2]
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Any time (expected average over 12-months)
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Secondary outcome [3]
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Major malignancy related adverse outcomes
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Assessment method [3]
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Major cancers - particularly virally driven malignancies, skin cancers
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Timepoint [3]
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Any time (expected average over 12-months)
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Secondary outcome [4]
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Major cardiovascular adverse outcomes
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Assessment method [4]
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4-point MACE: CV death, non-fatal MI, non-fatal stroke, UA requiring hospitalization; and cardiometabolic risks (post-transplant diabetes, dyslipidemia, obesity)
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Timepoint [4]
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Any time (expected average over 12-months)
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Secondary outcome [5]
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Chronic allograft dysfunction
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Assessment method [5]
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Decline in kidney function in the transplant from the baseline, histologically manifest as fibrosis (interstitial fibrosis and tubular atrophy, IFTA)
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Timepoint [5]
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Any time (expected average 60-months)
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Secondary outcome [6]
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BK virus associated nephropathy
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Assessment method [6]
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BK virus associated nephropathy biopsy evidence of positive SV40 stain in tubules
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Timepoint [6]
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At biopsy or during study follow up after biopsy (expected average 12-months)
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Secondary outcome [7]
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Albuminuria
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Assessment method [7]
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Based on urine albumin to creatinine ratio
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Timepoint [7]
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At biopsy or during study follow up after biopsy (expected average 12-months)
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Secondary outcome [8]
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Surrogate end-points
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Assessment method [8]
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eGFR slow and iBOX score
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Timepoint [8]
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At biopsy or during study follow up after biopsy (expected average 12-months)
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Secondary outcome [9]
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Delayed graft function (DGF)
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Assessment method [9]
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Need for dialysis within 7 days of transplantation
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Timepoint [9]
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At biopsy or during study follow up after biopsy (within 7 days of transplantation)
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Secondary outcome [10]
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Death censored graft loss (DCGL)
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Assessment method [10]
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Graft loss - excluding cases of death with functioning graft
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Timepoint [10]
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At biopsy or during study follow up after biopsy (expected average 12-months)
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Secondary outcome [11]
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Treatment resistant rejection
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Assessment method [11]
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Persistent rejection despite additional glucocorticoids and/or upscaling of maintenance immunosuppression
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Timepoint [11]
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At biopsy or during study follow up after biopsy (expected average 12-months)
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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.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/04/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2040
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Westmead Hospital - Westmead
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Recruitment hospital [2]
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Westmead Institute for Medical Research - Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Funding & Sponsors
Primary sponsor type
Other
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Name
Western Sydney Local Health District
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT06314230
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jennifer SY Li, MBBS, FRACP
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Address
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Country
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Phone
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06314230