An observational study in Transplant Complication and Kidney Transplant Rejection, sponsored by Western Sydney Local Health District. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by Western Sydney Local Health District · Observational
Investigator led, prospective, observational cohort study to detect genomic features which can predict outcomes following kidney transplantation.
Western Sydney Local Health District is the lead sponsor of 35 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult, kidney transplant (or kidney-pancreas transplant) recipients
Inclusion Criteria: All participants included in the study must be age ≥ 18 years old at time of enrolment and
Exclusion Criteria: Patients will be excluded from the study if they are
Enrolled at time of transplant or post transplant
Diagnostic Test: Biomarker discovery and validation - with focus on genomic biomarkers
Biomarker discovery and validation - with focus on genomic biomarkers
Death censored graft loss (DCGL)
Loss of functioning kidney transplant (not counted if patient died with functioning graft)
Time frame: At biopsy or during study follow up after biopsy (expected average over 60-months)
Biopsy proven rejection (BPAR)
Rejection diagnosed on kidney transplant biopsy
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
All cause graft loss
DCGL or death with functioning graft
Time frame: At biopsy or during study follow up after biopsy (expected average over 60-months)
Death
Death
Time frame: Any time during or after biopsy (expected over 60-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)
Hospital admission or emergency attendance
Hospital admission or emergency department visit for any reason
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Delayed Graft Function (DGF)
Need for dialysis within the first 7 days post transplantation
Time frame: within the first 7 days post transplantation
Kidney function
serum creatinine and eGFR post transplantation
Time frame: Months 1, 3, 12, 24, 36, 48, 60, 120 post transplantation
Albuminuria
albumin in the urine (UACR)
Time frame: Months 1, 3, 12 any time after 12-months trnasplantation
Surrogate end-point markers
eGFR slope and iBOX scores
Time frame: Months 3, 12, 24, 36, 48 and 60, 120 post transplantation
Borderline rejeciton
Based on banff scoring criteria for kidney biospies
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
chronic rejection; chronic transplant glomerulopathy; and interstitial fibrosis and tubular atrophy (IFTA) scores
Based on banff scoring for kidney biopsies
Time frame: At biopsy or during study follow up after biopsy (expected average over 12-months)
Recurrent disease
recurrence of original disease causing kidney failure
Time frame: At biopsy or during study follow up after biopsy (expected average 60-months)
BK virus complications
Viremia or virus associated nephropathy
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Major cardiovascular complications
3-point MACE: non fatal stroke, non fatal myocardial infarction, cardiovascular death
Time frame: At biopsy or during study follow up after biopsy (expected average 60-months)
Major infectious complications
any major fungal, bacterial or viral infection
Time frame: At biopsy or during study follow up after biopsy (expected average 60-months)
Malignancy post transplantation
any cancer type
Time frame: At biopsy or during study follow up after biopsy (expected average 60-months)
Kidney biopsy transcriptomic signature
Based on bulk and/or spatial transcriptomic experiments
Time frame: At biopsy - based on collected tissue sample
Kidney cell type composition
Cell type phenotyping of immune and kidney cell types
Time frame: At biopsy - based on collected tissue sample
Proteinomic signature
mass spectrometry or spatial proteinomic results
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Western Sydney Local Health District