Australian Genomics Of Chronic Allograft Dysfunction Study (AUSCAD)

July 14, 2025 updated by: Jennifer Li, Western Sydney Local Health District
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
      • Westmead, New South Wales, Australia, 2145

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Graft failure
Time Frame: Time Frame: At biopsy or during study follow up after biopsy (expected average 60-months)
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
Time Frame: At biopsy or during study follow up after biopsy (expected average 12-months)
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
Time Frame: At biopsy - based on collected tissue sample
Gene expression or variant profiles of participants
At biopsy - based on collected tissue sample

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Death censored graft loss (DCGL)
Time Frame: At biopsy or during study follow up after biopsy (expected average 12-months)
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
Time Frame: At biopsy or during study follow up after biopsy (expected average 12-months)
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)
Time Frame: At biopsy or during study follow up after biopsy (within 7 days of transplantation)
Need for dialysis within 7 days of transplantation
At biopsy or during study follow up after biopsy (within 7 days of transplantation)
Albuminuria
Time Frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Based on urine albumin to creatinine ratio
At biopsy or during study follow up after biopsy (expected average 12-months)
Surrogate end-points
Time Frame: At biopsy or during study follow up after biopsy (expected average 12-months)
eGFR slow and iBOX score
At biopsy or during study follow up after biopsy (expected average 12-months)
Death
Time Frame: At biopsy or during study follow up after biopsy (expected average over 60-months)
Death from any cause
At biopsy or during study follow up after biopsy (expected average over 60-months)
Major infectious adverse outcomes
Time Frame: Any time (expected average over 12-months)
Major viral, bacterial or fungal infections
Any time (expected average over 12-months)
Major malignancy related adverse outcomes
Time Frame: Any time (expected average over 12-months)
Major cancers - particularly virally driven malignancies, skin cancers
Any time (expected average over 12-months)
Major cardiovascular adverse outcomes
Time Frame: Any time (expected average over 12-months)
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
Time Frame: Any time (expected average 60-months)
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
Time Frame: At biopsy or during study follow up after biopsy (expected average 12-months)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Western Sydney Local Health District

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2012

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2040

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2040

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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