Australian Genomics Of Chronic Allograft Dysfunction Study

Western Sydney Local Health District500 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

Kidney Transplant Rejection Kidney Transplant; Complications

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Graft failure

Failure of the kidney transplant, resulting in death or return to dialysis

Time frame: 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

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

Gene profile

Gene expression or variant profiles of participants

Time frame: At biopsy - based on collected tissue sample

Secondary Outcomes

Death

Death from any cause

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

Major infectious adverse outcomes

Major viral, bacterial or fungal infections

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

Major malignancy related adverse outcomes

Major cancers - particularly virally driven malignancies, skin cancers

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

Major cardiovascular adverse outcomes

4-point MACE: CV death, non-fatal MI, non-fatal stroke, UA requiring hospitalization; and cardiometabolic risks (post-transplant diabetes, dyslipidemia, obesity)

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

Chronic allograft dysfunction

Decline in kidney function in the transplant from the baseline, histologically manifest as fibrosis (interstitial fibrosis and tubular atrophy, IFTA)

Time frame: Any time (expected average 60-months)

BK virus associated nephropathy

BK virus associated nephropathy biopsy evidence of positive SV40 stain in tubules

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

Albuminuria

Based on urine albumin to creatinine ratio

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

Surrogate end-points

eGFR slow and iBOX score

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

Delayed graft function (DGF)

Need for dialysis within 7 days of transplantation

Time frame: At biopsy or during study follow up after biopsy (within 7 days of transplantation)

Death censored graft loss (DCGL)

Graft loss - excluding cases of death with functioning graft

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

Treatment resistant rejection

Persistent rejection despite additional glucocorticoids and/or upscaling of maintenance immunosuppression

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

Australian Genomics Of Chronic Allograft Dysfunction Study

Overview

Conditions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts