Transplant ComplicationGEM-KiTNCT06365411
GEnomic Medicine in Kidney Transplantation Study
An observational study of Transplant Complication and Kidney Transplant Rejection, run by Western Sydney Local Health District at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Transplant Complication, Kidney Transplant Rejection
- What is being tested?
- Biomarker discovery and validation - with focus on genomic biomarkers
- How many people
- 1,000 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Nov 2025to 1 Jan 2035
- Phase
- Observational
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 80 years
- All sexes
- Adult, Older adult
Study population: 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
- 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)
Exclusion Criteria: Patients will be excluded from the study if they are
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Westmead Institute for Medical Research
Westmead, New South Wales, 2145
About this study
Investigator led, prospective, observational cohort study to detect genomic features which can predict outcomes following kidney transplantation.
- Determine non-HLA genomic mismatches between donor-recipient pairs which impact kidney allograft survival following transplantation
- Derive polygenic risk scores on pre-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction
- Derive polygenic risk scores on post-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction
- Being tested
- Biomarker discovery and validation - with focus on genomic biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker discovery and validation - with focus on genomic biomarkersDiagnostic test
Biomarker discovery and validation - with focus on genomic biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Kidney Transplant Recipients | Enrolled at time of transplant or post transplant Receives: Diagnostic Test: Biomarker discovery and validation - with focus on genomic biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death censored graft loss (DCGL)
Loss of functioning kidney transplant (not counted if patient died with functioning graft)
Measured: At biopsy or during study follow up after biopsy (expected average over 60-months)
Biopsy proven rejection (BPAR)
Rejection diagnosed on kidney transplant biopsy
Measured: At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary outcomes (18)
All cause graft loss
DCGL or death with functioning graft
Measured: At biopsy or during study follow up after biopsy (expected average over 60-months)
Death
Death
Measured: Any time during or after biopsy (expected over 60-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)
Hospital admission or emergency attendance
Hospital admission or emergency department visit for any reason
Measured: 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
Measured: within the first 7 days post transplantation
Kidney function
serum creatinine and eGFR post transplantation
Measured: Months 1, 3, 12, 24, 36, 48, 60, 120 post transplantation
Albuminuria
albumin in the urine (UACR)
Measured: Months 1, 3, 12 any time after 12-months trnasplantation
Surrogate end-point markers
eGFR slope and iBOX scores
Measured: Months 3, 12, 24, 36, 48 and 60, 120 post transplantation
Borderline rejeciton
Based on banff scoring criteria for kidney biospies
Measured: 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
Measured: At biopsy or during study follow up after biopsy (expected average over 12-months)
Recurrent disease
recurrence of original disease causing kidney failure
Measured: At biopsy or during study follow up after biopsy (expected average 60-months)
BK virus complications
Viremia or virus associated nephropathy
Measured: 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
Measured: At biopsy or during study follow up after biopsy (expected average 60-months)
Major infectious complications
any major fungal, bacterial or viral infection
Measured: At biopsy or during study follow up after biopsy (expected average 60-months)
Malignancy post transplantation
any cancer type
Measured: 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
Measured: At biopsy - based on collected tissue sample
Kidney cell type composition
Cell type phenotyping of immune and kidney cell types
Measured: At biopsy - based on collected tissue sample
Proteinomic signature
mass spectrometry or spatial proteinomic results
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 Apr 2024
- Study start1 Nov 2025
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant ComplicationStudies 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
- 1,000 participants (estimated)
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
- NCT06365411
- Sponsor's protocol ID
- GEM-KiT
- Acronym
- GEM-KiT
- Status last verified
- Oct 2026
- First submitted
- 10 Mar 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No