GEnomic Medicine in Kidney Transplantation Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorWestern Sydney Local Health District
About this trial
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
This trial does not accept healthy volunteersQualifiers
able to provide informed consent (interpreter permitted) for enrolment
consenting to longitudinal follow up (can withdraw post enrolment)
consenting to provide samples for biobanking, including blood, urine, faecal and/or kidney biopsy tissue (collected prospectively, separate to routine care)
Disqualifiers
unable (or unwilling) to provide consent, or
have life-expectancy less than 6-months, or
have received a haematopoietic stem cell transplant in the past 5 years.
Trial population
Adult, kidney transplant (or kidney-pancreas transplant) recipients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biomarker discovery and validation - with focus on genomic biomarkers
Diagnostic testBiomarker discovery and validation - with focus on genomic biomarkers
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Kidney Transplant Recipients1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
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)2
Death
Death
Time frame
Any time during or after biopsy (expected over 60-months)3
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)4
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)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: