GEnomic Medicine in Kidney Transplantation Study (GEM-KiT)

Western Sydney Local Health District

Status: Not yet enrolling

Conditions: Transplant Complication; Kidney Transplant Rejection

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

Study type: Observational

Funder types: Other

Identifiers

NCT06365411

GEM-KiT

Details and patient eligibility

About

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

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

1,000 participants in 1 patient group

Kidney Transplant Recipients

Description:

Enrolled at time of transplant or post transplant

Treatment:

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