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GEnomic Medicine in Kidney Transplantation Study | Clinical Trials | Clareo Health

NOT_YET_RECRUITING

GEnomic Medicine in Kidney Transplantation Study

NCT06365411•Western Sydney Local Health District

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•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.

Key Dates

Start Date

June 3, 2025

Primary Completion Date

January 1, 2030

Completion Date

January 1, 2035

Last Updated

March 28, 2025

Enrollment

1,000

ESTIMATED participants

Conditions

Transplant ComplicationKidney Transplant Rejection

Interventions

Biomarker discovery and validation - with focus on genomic biomarkers

DIAGNOSTIC_TEST

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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GEnomic Medicine in Kidney Transplantation Study

Inclusion Criteria

Exclusion Criteria

Multidisciplinary Intervention for Adults With Chronic Graft-versus-host Disease

A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy

Treatment of Chronic Active Antibody Mediated Rejection With Tocilizumab

Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)

Impact of the Microbiota on the Likelihood of Renal Graft Rejection

Added Value of 18 FDG Pet-scanner in Diagnosis and Management of Subclinical Rejection in Kidney Transplant Patients