GEnomic Medicine in Kidney Transplantation Study

NCT ID: NCT06365411

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-03

Study Completion Date

2035-01-01

Brief Summary

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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

Detailed Description

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Conditions

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Transplant Complication Kidney Transplant Rejection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Kidney Transplant Recipients

Enrolled at time of transplant or post transplant

Biomarker discovery and validation - with focus on genomic biomarkers

Intervention Type DIAGNOSTIC_TEST

Biomarker discovery and validation - with focus on genomic biomarkers

Interventions

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Biomarker discovery and validation - with focus on genomic biomarkers

Biomarker discovery and validation - with focus on genomic biomarkers

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Western Sydney Local Health District

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Li

Nephrologist and Transplant Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Jennifer SY Li, MBBS, FRACP

Role: CONTACT

612 88905555

Philip J O'Connell, MBBS, FRACP

Role: CONTACT

612 88905555

Other Identifiers

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GEM-KiT

Identifier Type: -

Identifier Source: org_study_id

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