Australian Genomics Of Chronic Allograft Dysfunction Study

NCT06314230 | Recruiting DMC

• 1 other identifier: AUSCAD
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Transplant Rejection; Kidney Transplant; Complications

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Death

  At biopsy or during study follow up after biopsy (expected average over 60-months)

• Major infectious adverse outcomes

  Any time (expected average over 12-months)

• Major malignancy related adverse outcomes

  Any time (expected average over 12-months)

• Major cardiovascular adverse outcomes

  Any time (expected average over 12-months)

• Chronic allograft dysfunction

  Any time (expected average 60-months)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western Sydney Local Health District: lead

Study Sites (2)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Westmead Institute for Medical Research

Westmead, New South Wales, 2145, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Enrolment is allocated time 0 (baseline). At times 0, 1, 3, 6, 12, 18 and 24 months, patients will be asked to provide blood and urine samples. At time 0, 3, 12 and indication biopsies, a core kidney biopsy if this already being performed as part of clinical care. These samples will biobanked and used to answer the primary questions of this study and consent will be obtained for samples to be used in future research in to renal related disorders. After 24months, only medical records will be reviewed in the majority of patients, collecting key outcome measures of kidney function, rejection, major complications or allograft failure (resulting in death or return to dialysis). Patients are invited to participate in the extended follow up phase (after 24months)- where patients may choose to submit blood/urine/tissue samples if an indication biopsy performed as part of their clinical care.

Central Study Contacts

Jennifer SY Li, MBBS, FRACP

CONTACT

jennifer.li@health.nsw.gov.au

Philip J O'Connell, MBBS, FRACP

CONTACT

philip.oconnell@sydney.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist and Transplant Physician

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 15, 2024
• Study Start: April 26, 2012
• Primary Completion (Estimated): January 1, 2040
• Study Completion (Estimated): January 1, 2040
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)