Australian Genomics Of Chronic Allograft Dysfunction Study (AUSCAD)

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplant Rejection; Kidney Transplant; Complications

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Jennifer SY Li, MBBS, FRACP; Email: jennifer.li@health.nsw.gov.au
• Study Contact Backup: Name: Philip J O'Connell, MBBS, FRACP; Email: philip.oconnell@sydney.edu.au

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital
      • Contact: Jennifer SY Li, MBBS, FRACP; Email: jennifer.li@health.nsw.gov.au
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Institute for Medical Research
      • Contact: Philip J O'Connell, MBBS, FRACP; Email: philip.oconnell@sydney.edu.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft failure	Failure of the kidney transplant, resulting in death or return to dialysis	Time Frame: At biopsy or during study follow up after biopsy (expected average 60-months)
Allograft rejection	Any rejection (acute or chronic, borderline, T-cell, antibody or mixed rejection) in the kidney transplant	At biopsy or during study follow up after biopsy (expected average 12-months)
Gene profile	Gene expression or variant profiles of participants	At biopsy - based on collected tissue sample

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death censored graft loss (DCGL)	Graft loss - excluding cases of death with functioning graft	At biopsy or during study follow up after biopsy (expected average 12-months)
Treatment resistant rejection	Persistent rejection despite additional glucocorticoids and/or upscaling of maintenance immunosuppression	At biopsy or during study follow up after biopsy (expected average 12-months)
Delayed graft function (DGF)	Need for dialysis within 7 days of transplantation	At biopsy or during study follow up after biopsy (within 7 days of transplantation)
Albuminuria	Based on urine albumin to creatinine ratio	At biopsy or during study follow up after biopsy (expected average 12-months)
Surrogate end-points	eGFR slow and iBOX score	At biopsy or during study follow up after biopsy (expected average 12-months)
Death	Death from any cause	At biopsy or during study follow up after biopsy (expected average over 60-months)
Major infectious adverse outcomes	Major viral, bacterial or fungal infections	Any time (expected average over 12-months)
Major malignancy related adverse outcomes	Major cancers - particularly virally driven malignancies, skin cancers	Any time (expected average over 12-months)
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)	Any time (expected average over 12-months)
Chronic allograft dysfunction	Decline in kidney function in the transplant from the baseline, histologically manifest as fibrosis (interstitial fibrosis and tubular atrophy, IFTA)	Any time (expected average 60-months)
BK virus associated nephropathy	BK virus associated nephropathy biopsy evidence of positive SV40 stain in tubules	At biopsy or during study follow up after biopsy (expected average 12-months)

Collaborators and Investigators

• Sponsor: Western Sydney Local Health District

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2012
• Primary Completion (Estimated): January 1, 2040
• Study Completion (Estimated): January 1, 2040

Study Registration Dates

• First Submitted: March 10, 2024
• First Submitted That Met QC Criteria: March 10, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: AUSCAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No