GEnomic Medicine in Kidney Transplantation Study

Kidney Transplant Rejection Clinical Trial

— GEM-KiT  

Official title:

GEnomic Medicine in Kidney Transplantation Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06365411
• Other study ID #: GEM-KiT
• Status: Not yet recruiting
• Start date: June 3, 2024
• Est. completion date: January 1, 2035

Study information

• Verified date: April 2024
• Source: Western Sydney Local Health District
• Contact: Jennifer SY Li, MBBS, FRACP
• Phone: 612 88905555
• Email: jennifer.li[@]health.nsw.gov.au
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: January 1, 2035
• Est. primary completion date: January 1, 2030
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant Rejection

Intervention

Diagnostic Test:
• Biomarker discovery and validation - with focus on genomic biomarkers
Biomarker discovery and validation - with focus on genomic biomarkers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western Sydney Local Health District

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Biopsy proven rejection (BPAR)	Rejection diagnosed on kidney transplant biopsy	At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary	All cause graft loss	DCGL or death with functioning graft	At biopsy or during study follow up after biopsy (expected average over 60-months)
Secondary	Death	Death	Any time during or after biopsy (expected over 60-months)
Secondary	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)
Secondary	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)
Secondary	Delayed Graft Function (DGF)	Need for dialysis within the first 7 days post transplantation	within the first 7 days post transplantation
Secondary	Kidney function	serum creatinine and eGFR post transplantation	Months 1, 3, 12, 24, 36, 48, 60, 120 post transplantation
Secondary	Albuminuria	albumin in the urine (UACR)	Months 1, 3, 12 any time after 12-months trnasplantation
Secondary	Surrogate end-point markers	eGFR slope and iBOX scores	Months 3, 12, 24, 36, 48 and 60, 120 post transplantation
Secondary	Borderline rejeciton	Based on banff scoring criteria for kidney biospies	At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary	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)
Secondary	Recurrent disease	recurrence of original disease causing kidney failure	At biopsy or during study follow up after biopsy (expected average 60-months)
Secondary	BK virus complications	Viremia or virus associated nephropathy	At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary	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)
Secondary	Major infectious complications	any major fungal, bacterial or viral infection	At biopsy or during study follow up after biopsy (expected average 60-months)
Secondary	Malignancy post transplantation	any cancer type	At biopsy or during study follow up after biopsy (expected average 60-months)
Secondary	Kidney biopsy transcriptomic signature	Based on bulk and/or spatial transcriptomic experiments	At biopsy - based on collected tissue sample
Secondary	Kidney cell type composition	Cell type phenotyping of immune and kidney cell types	At biopsy - based on collected tissue sample
Secondary	Proteinomic signature	mass spectrometry or spatial proteinomic results	At biopsy or during study follow up after biopsy (expected average 12-months)