Kidney Transplant RejectionAUSCADNCT06314230
Australian Genomics Of Chronic Allograft Dysfunction Study
An observational study of Kidney Transplant Rejection and Kidney Transplant; Complications, run by Western Sydney Local Health District at 2 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplant Rejection, Kidney Transplant; Complications
- How many people
- 500 participants
- Where
- 2 sitesAustralia
- Study dates
- 26 Apr 2012to 1 Jan 2040
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult, kidney transplant recipients who receive a transplant at Westmead Hospital are eligible for enrolment if they meet the above inclusion/exclusion criteria. They patients can receive a kidney transplant from either kidney-only or kidney-pancreas transplant. They may receive a kidney from either living or deceased donor. Participants are formally enrolled after informed consent and if the transplant proceeds. Participants are allowed to withdraw from the study at any time.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Australia2 sites
Westmead Hospital
Westmead, New South Wales, 2145
Westmead Institute for Medical Research
Westmead, New South Wales, 2145
About this 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplant recipients | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft failure
Failure of the kidney transplant, resulting in death or return to dialysis
Measured: 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
Measured: At biopsy or during study follow up after biopsy (expected average 12-months)
Gene profile
Gene expression or variant profiles of participants
Measured: At biopsy - based on collected tissue sample
Secondary outcomes (11)
Death
Death from any cause
Measured: At biopsy or during study follow up after biopsy (expected average over 60-months)
Major infectious adverse outcomes
Major viral, bacterial or fungal infections
Measured: Any time (expected average over 12-months)
Major malignancy related adverse outcomes
Major cancers - particularly virally driven malignancies, skin cancers
Measured: 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)
Measured: 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)
Measured: Any time (expected average 60-months)
BK virus associated nephropathy
BK virus associated nephropathy biopsy evidence of positive SV40 stain in tubules
Measured: At biopsy or during study follow up after biopsy (expected average 12-months)
Albuminuria
Based on urine albumin to creatinine ratio
Measured: At biopsy or during study follow up after biopsy (expected average 12-months)
Surrogate end-points
eGFR slow and iBOX score
Measured: 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
Measured: 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
Measured: 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
Measured: At biopsy or during study follow up after biopsy (expected average 12-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start26 Apr 2012
- Primary completion1 Jan 2040 (estimated)
- Study completion1 Jan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Li, Western Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314230
- Sponsor's protocol ID
- AUSCAD
- Acronym
- AUSCAD
- Status last verified
- Oct 2026
- First submitted
- 10 Mar 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Australian Genomics Of Chronic Allograft Dysfunction Study
- ClinicalTrials.gov ID
- NCT06314230
- Acronym / sponsor ID
- AUSCAD / AUSCAD
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Study start
- 26 Apr 2012 (actual)
- Primary completion
- 1 Jan 2040 (estimated)
- Study completion
- 1 Jan 2040 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipients | – | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, kidney transplant recipients who receive a transplant at Westmead Hospital are eligible for enrolment if they meet the above inclusion/exclusion criteria. They patients can receive a kidney transplant from either kidney-only or kidney-pancreas transplant. They may receive a kidney from either living or deceased donor. Participants are formally enrolled after informed consent and if the transplant proceeds. Participants are allowed to withdraw from the study at any time.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Gene profile
Time frame: At biopsy - based on collected tissue sample
Gene expression or variant profiles of participants
11 secondary outcomes
Death
Time frame: At biopsy or during study follow up after biopsy (expected average over 60-months)
Major infectious adverse outcomes
Time frame: Any time (expected average over 12-months)
Major malignancy related adverse outcomes
Time frame: Any time (expected average over 12-months)
Major cardiovascular adverse outcomes
Time frame: Any time (expected average over 12-months)
Chronic allograft dysfunction
Time frame: Any time (expected average 60-months)
BK virus associated nephropathy
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Albuminuria
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Surrogate end-points
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Delayed graft function (DGF)
Time frame: At biopsy or during study follow up after biopsy (within 7 days of transplantation)
Death censored graft loss (DCGL)
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Treatment resistant rejection
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Rejection and Kidney Transplant; Complications, run by Western Sydney Local Health District at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft failure (time frame: Time Frame: At biopsy or during study follow up after biopsy (expected average 60-months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.