GEnomic Medicine in Kidney Transplantation Study

N/ANot Yet RecruitingNCT06365411

Western Sydney Local Health District1,000 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Transplant Complication Kidney Transplant Rejection

Interventions

Biomarker discovery and validation - with focus on genomic biomarkersDIAGNOSTIC_TEST

Biomarker discovery and validation - with focus on genomic biomarkers

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

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

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)

Death

Time frame: Any time during or after biopsy (expected over 60-months)

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)

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)

Delayed Graft Function (DGF)

Need for dialysis within the first 7 days post transplantation

Time frame: within the first 7 days post transplantation

Kidney function

Central Contacts

Jennifer SY Li, MBBS, FRACP

CONTACT

612 88905555 jennifer.li@health.nsw.gov.au

Philip J O'Connell, MBBS, FRACP

CONTACT

612 88905555 philip.oconnell@sydney.edu.au

Data from ClinicalTrials.gov

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