Australian Genomics Of Chronic Allograft Dysfunction Study (AUSCAD)

Western Sydney Local Health District

Status: Enrolling

Conditions: Kidney Transplant; Complications; Kidney Transplant Rejection

Study type: Observational

Funder types: Other

Identifiers

NCT06314230

AUSCAD

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Kidney transplant recipients

Description:

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.