Clinical trial NCT06365411: GEnomic Medicine in Kidney Transplantation Study
Official title: GEnomic Medicine in Kidney Transplantation Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Transplant Complication
Kidney Transplant Rejection
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult, kidney transplant (or kidney-pancreas transplant) recipients

Brief summary: Investigator led, prospective, observational cohort study to detect genomic features which can predict outcomes following kidney transplantation.

1. Determine non-HLA genomic mismatches between donor-recipient pairs which impact kidney allograft survival following transplantation
2. Derive polygenic risk scores on pre-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction
3. Derive polygenic risk scores on post-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction


Eligibility criteria: Inclusion Criteria: All participants included in the study must be age ≥ 18 years old at time of enrolment and

1. able to provide informed consent (interpreter permitted) for enrolment
2. consenting to longitudinal follow up (can withdraw post enrolment)
3. consenting to provide samples for biobanking, including blood, urine, faecal and/or kidney biopsy tissue (collected prospectively, separate to routine care)

Exclusion Criteria: Patients will be excluded from the study if they are

1. unable (or unwilling) to provide consent, or
2. have life-expectancy less than 6-months, or
3. have received a haematopoietic stem cell transplant in the past 5 years.

Primary outcomes:
measure: Death censored graft loss (DCGL)
timeFrame: At biopsy or during study follow up after biopsy (expected average over 60-months)
measure: Biopsy proven rejection (BPAR)
timeFrame: At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary outcomes:
measure: All cause graft loss
timeFrame: At biopsy or during study follow up after biopsy (expected average over 60-months)
measure: Death
timeFrame: Any time during or after biopsy (expected over 60-months)
measure: Treatment resistant rejection
timeFrame: At biopsy or during study follow up after biopsy (expected average 12-months)
measure: Hospital admission or emergency attendance
timeFrame: At biopsy or during study follow up after biopsy (expected average 12-months)
measure: Delayed Graft Function (DGF)
timeFrame: within the first 7 days post transplantation
measure: Kidney function
timeFrame: Months 1, 3, 12, 24, 36, 48, 60, 120 post transplantation
measure: Albuminuria
timeFrame: Months 1, 3, 12 any time after 12-months trnasplantation
measure: Surrogate end-point markers
timeFrame: Months 3, 12, 24, 36, 48 and 60, 120 post transplantation
measure: Borderline rejeciton
timeFrame: At biopsy or during study follow up after biopsy (expected average 12-months)
measure: chronic rejection; chronic transplant glomerulopathy; and interstitial fibrosis and tubular atrophy (IFTA) scores
timeFrame: At biopsy or during study follow up after biopsy (expected average over 12-months)
measure: Recurrent disease
timeFrame: At biopsy or during study follow up after biopsy (expected average 60-months)
measure: BK virus complications
timeFrame: At biopsy or during study follow up after biopsy (expected average 12-months)
measure: Major cardiovascular complications
timeFrame: At biopsy or during study follow up after biopsy (expected average 60-months)
measure: Major infectious complications
timeFrame: At biopsy or during study follow up after biopsy (expected average 60-months)
measure: Malignancy post transplantation
timeFrame: At biopsy or during study follow up after biopsy (expected average 60-months)
measure: Kidney biopsy transcriptomic signature
timeFrame: At biopsy - based on collected tissue sample
measure: Kidney cell type composition
timeFrame: At biopsy - based on collected tissue sample
measure: Proteinomic signature
timeFrame: At biopsy or during study follow up after biopsy (expected average 12-months)
Other outcomes:
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