Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Investigator led, prospective, observational cohort study to detect genomic features which can predict outcomes following kidney transplantation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kidney Transplant Recipients | Enrolled at time of transplant or post transplant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarker discovery and validation - with focus on genomic biomarkers | Diagnostic Test | Biomarker discovery and validation - with focus on genomic biomarkers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death censored graft loss (DCGL) | Loss of functioning kidney transplant (not counted if patient died with functioning graft) | At biopsy or during study follow up after biopsy (expected average over 60-months) |
| Biopsy proven rejection (BPAR) | Rejection diagnosed on kidney transplant biopsy | At biopsy or during study follow up after biopsy (expected average 12-months) |
| Measure | Description | Time Frame |
|---|---|---|
| All cause graft loss | DCGL or death with functioning graft | At biopsy or during study follow up after biopsy (expected average over 60-months) |
| Death | Death |
Not provided
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
Not provided
Not provided
Adult, kidney transplant (or kidney-pancreas transplant) recipients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer SY Li, MBBS, FRACP | Contact | 612 88905555 | jennifer.li@health.nsw.gov.au | |
| Philip J O'Connell, MBBS, FRACP | Contact | 612 88905555 | philip.oconnell@sydney.edu.au |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Blood sampling: all patients will submit blood samples (approximately 10 teaspoons), including
| Any time during or after biopsy (expected over 60-months) |
| 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) |
| Hospital admission or emergency attendance | Hospital admission or emergency department visit for any reason | 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 | within the first 7 days post transplantation |
| Kidney function | serum creatinine and eGFR post transplantation | Months 1, 3, 12, 24, 36, 48, 60, 120 post transplantation |
| Albuminuria | albumin in the urine (UACR) | Months 1, 3, 12 any time after 12-months trnasplantation |
| Surrogate end-point markers | eGFR slope and iBOX scores | Months 3, 12, 24, 36, 48 and 60, 120 post transplantation |
| Borderline rejeciton | Based on banff scoring criteria for kidney biospies | 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 | At biopsy or during study follow up after biopsy (expected average over 12-months) |
| Recurrent disease | recurrence of original disease causing kidney failure | At biopsy or during study follow up after biopsy (expected average 60-months) |
| BK virus complications | Viremia or virus associated nephropathy | 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 | At biopsy or during study follow up after biopsy (expected average 60-months) |
| Major infectious complications | any major fungal, bacterial or viral infection | At biopsy or during study follow up after biopsy (expected average 60-months) |
| Malignancy post transplantation | any cancer type | 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 | At biopsy - based on collected tissue sample |
| Kidney cell type composition | Cell type phenotyping of immune and kidney cell types | At biopsy - based on collected tissue sample |
| Proteinomic signature | mass spectrometry or spatial proteinomic results | At biopsy or during study follow up after biopsy (expected average 12-months) |