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NCT Number: NCT06314230

Australian Genomics Of Chronic Allograft Dysfunction Study

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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Key information

Conditions

Kidney Transplant Rejection Kidney Transplant; Complications

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Westmead Hospital, Westmead, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. Gene profile

    Time frame: At biopsy - based on collected tissue sample

    Gene expression or variant profiles of participants

Secondary outcomes

  1. Death

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

    Death from any cause

  2. Major infectious adverse outcomes

    Time frame: Any time (expected average over 12-months)

    Major viral, bacterial or fungal infections

  3. Major malignancy related adverse outcomes

    Time frame: Any time (expected average over 12-months)

    Major cancers - particularly virally driven malignancies, skin cancers

  4. 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)

  5. 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)

  6. 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

  7. Albuminuria

    Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)

    Based on urine albumin to creatinine ratio

  8. Surrogate end-points

    Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)

    eGFR slow and iBOX score

  9. 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

  10. 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

  11. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer SY Li, MBBS, FRACP

CONTACT

[email protected]

Philip J O'Connell, MBBS, FRACP

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Western Sydney Local Health District

Other

Registry information

Acronym: AUSCAD

Important dates

Study start
2012
Primary completion
2040
Study completion
2040
First posted
Mar 15, 2024
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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