Australian Genomics Of Chronic Allograft Dysfunction Study

Kidney Transplant; Complications Clinical Trial

— AUSCAD  

Official title:

Australian Genomics Of Chronic Allograft Dysfunction Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06314230
• Other study ID #: AUSCAD
• Status: Recruiting
• Start date: April 26, 2012
• Est. completion date: January 1, 2040

Study information

• Verified date: April 2024
• Source: Western Sydney Local Health District
• Contact: Jennifer SY Li, MBBS, FRACP
• Email: jennifer.li[@]health.nsw.gov.au
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 1, 2040
• Est. primary completion date: January 1, 2040
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant Rejection
• Kidney Transplant; Complications

Locations

Country	Name	City	State
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Westmead Institute for Medical Research	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Western Sydney Local Health District

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft failure	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)
Primary	Allograft rejection	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)
Primary	Gene profile	Gene expression or variant profiles of participants	At biopsy - based on collected tissue sample
Secondary	Death	Death from any cause	At biopsy or during study follow up after biopsy (expected average over 60-months)
Secondary	Major infectious adverse outcomes	Major viral, bacterial or fungal infections	Any time (expected average over 12-months)
Secondary	Major malignancy related adverse outcomes	Major cancers - particularly virally driven malignancies, skin cancers	Any time (expected average over 12-months)
Secondary	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)	Any time (expected average over 12-months)
Secondary	Chronic allograft dysfunction	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)
Secondary	BK virus associated nephropathy	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)
Secondary	Albuminuria	Based on urine albumin to creatinine ratio	At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary	Surrogate end-points	eGFR slow and iBOX score	At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary	Delayed graft function (DGF)	Need for dialysis within 7 days of transplantation	At biopsy or during study follow up after biopsy (within 7 days of transplantation)
Secondary	Death censored graft loss (DCGL)	Graft loss - excluding cases of death with functioning graft	At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary	Treatment resistant rejection	Persistent rejection despite additional glucocorticoids and/or upscaling of maintenance immunosuppression	At biopsy or during study follow up after biopsy (expected average 12-months)