GEnomic Medicine in Kidney Transplantation Study

NCT06365411 | Not Yet Recruiting

• 1 other identifier: GEM-KiT
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigator led, prospective, observational cohort study to detect genomic features which can predict outcomes following kidney transplantation.

1. 1.Determine non-HLA genomic mismatches between donor-recipient pairs which impact kidney allograft survival following transplantation
2. 2.Derive polygenic risk scores on pre-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction
3. 3.Derive polygenic risk scores on post-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction

Conditions

Transplant Complication; Kidney Transplant Rejection

Outcome Measures

Primary Outcomes (2)

• 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)

• Biopsy proven rejection (BPAR)

  Rejection diagnosed on kidney transplant biopsy

  At biopsy or during study follow up after biopsy (expected average 12-months)

Secondary Outcomes (18)

• All cause graft loss

  At biopsy or during study follow up after biopsy (expected average over 60-months)

• Death

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

• Treatment resistant rejection

  At biopsy or during study follow up after biopsy (expected average 12-months)

• Hospital admission or emergency attendance

  At biopsy or during study follow up after biopsy (expected average 12-months)

• Delayed Graft Function (DGF)

  within the first 7 days post transplantation

Study Arms (1)

Kidney Transplant Recipients

Enrolled at time of transplant or post transplant

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

Interventions

Biomarker discovery and validation - with focus on genomic biomarkers DIAGNOSTIC_TEST

Biomarker discovery and validation - with focus on genomic biomarkers

Kidney Transplant Recipients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult, kidney transplant (or kidney-pancreas transplant) recipients

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western Sydney Local Health District: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood sampling: all patients will submit blood samples (approximately 10 teaspoons), including * Blood (15ml) drawn into PAX gene tubes for extraction of genomic material (eg DNA, RNA) * Kidney biopsy sample: For patients undergoing kidney biopsy procedure for any clinical indication (part of their clinical care, independent of the study), a dedicated sample of kidney biopsy may be collected for the study with the patient's permission * Mid-stream urine sample for pellet and supernatant and then stored at -80'c * Faecal sample in dedicated gut microbiome kits and then stored at -80'c

Central Study 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist and Transplant Physician

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: April 15, 2024
• Study Start: June 3, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2035
• Last Updated: March 28, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share