Actively Recruiting

Age: 18Years - 75Years
All Genders
ID06314230

Australian Genomics Of Chronic Allograft Dysfunction Study Observational Study of Kidney and Kidney-Pancreas Transplant Recipients

Led by Western Sydney Local Health District · Updated on 2025-07-17

500

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting the Australian Genomics of Chronic Allograft Dysfunction (AUSCAD) study, a prospective observational study at Westmead Hospital. The study enrolls patients at the time of kidney or kidney-pancreas transplant to track their post-transplant outcomes. The main goal is to understand how gene expression and immune responses relate to important outcomes such as chronic rejection and graft loss. Participants include kidney or kidney-pancreas transplant recipients who are followed over time. The study collects data on risk factors and analyzes blood, urine, and kidney tissue samples. It is non-interventional, meaning no treatments are assigned by the study, and it observes natural outcomes and gene profiles. During the study, researchers monitor participants for graft failure, allograft rejection, and gene profiles at biopsy and follow-up visits up to about 60 months. Additional outcomes tracked include death, infections, malignancies, cardiovascular events, chronic allograft dysfunction, and other transplant-related complications. Participation involves regular clinical follow-up and sample collection to better understand transplant success and challenges.

CONDITIONS

Brief Title

Australian Genomics Of Chronic Allograft Dysfunction Study

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Living or deceased donor kidney transplant candidate
  • Any biological sex
  • Aged between 18 and 75 years
  • Able to understand and provide informed consent
  • Deceased donor individuals with research consent obtained at organ retrieval
  • Identifiable living donors who have consented to participate
Not Eligible

You will not qualify if you...

  • Prior sensitization in living donor recipients or positive crossmatch in cadaveric donor recipients
  • Recipients of multiple organ transplants except kidney-pancreas transplants
  • Unable or unwilling to give written informed consent or comply with study protocol
  • High risk populations including pregnant women, children under 18 years, and prisoners
  • Non English speaking individuals who do not understand study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At biopsy

Participants provide blood, urine, and kidney samples for analysis and correlation with transplant outcomes.

1 visit (in-person) at time of biopsy

Long-term Monitoring

Duration - Up to 60 months

Participants are observed over time to monitor graft function, rejection, and other health outcomes related to their transplant.

Periodic visits depending on clinical care

Trial Site Locations

Total: 2 locations

1

Westmead Hospital

Westmead, New South Wales, Australia, 2145

Actively Recruiting

2

Westmead Institute for Medical Research

Westmead, New South Wales, Australia, 2145

Actively Recruiting

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Research Team

J

Jennifer SY Li, MBBS, FRACP

P

Philip J O'Connell, MBBS, FRACP

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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