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NCT Number: NCT06365411

GEnomic Medicine in Kidney Transplantation Study

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

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Key information

Conditions

Transplant Complication Kidney Transplant Rejection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All participants included in the study must be age ≥ 18 years old at time of enrolment and

  • 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)

Exclusion criteria

Patients will be excluded from the study if they are

  • 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.

Treatment and study plan

Biomarker discovery and validation - with focus on genomic biomarkers

Diagnostic Test

Biomarker discovery and validation - with focus on genomic biomarkers

Primary outcomes

  1. Death censored graft loss (DCGL)

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

    Loss of functioning kidney transplant (not counted if patient died with functioning graft)

  2. Biopsy proven rejection (BPAR)

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

    Rejection diagnosed on kidney transplant biopsy

Secondary outcomes

  1. All cause graft loss

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

    DCGL or death with functioning graft

  2. Death

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

    Death

  3. Treatment resistant rejection

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

    Persistent rejection despite additional glucocorticoids and/or upscaling of maintenance immunosuppression

  4. Hospital admission or emergency attendance

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

    Hospital admission or emergency department visit for any reason

  5. Delayed Graft Function (DGF)

    Time frame: within the first 7 days post transplantation

    Need for dialysis within the first 7 days post transplantation

  6. Kidney function

    Time frame: Months 1, 3, 12, 24, 36, 48, 60, 120 post transplantation

    serum creatinine and eGFR post transplantation

  7. Albuminuria

    Time frame: Months 1, 3, 12 any time after 12-months trnasplantation

    albumin in the urine (UACR)

  8. Surrogate end-point markers

    Time frame: Months 3, 12, 24, 36, 48 and 60, 120 post transplantation

    eGFR slope and iBOX scores

  9. Borderline rejeciton

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

    Based on banff scoring criteria for kidney biospies

  10. chronic rejection; chronic transplant glomerulopathy; and interstitial fibrosis and tubular atrophy (IFTA) scores

    Time frame: At biopsy or during study follow up after biopsy (expected average over 12-months)

    Based on banff scoring for kidney biopsies

  11. Recurrent disease

    Time frame: At biopsy or during study follow up after biopsy (expected average 60-months)

    recurrence of original disease causing kidney failure

  12. BK virus complications

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

    Viremia or virus associated nephropathy

  13. Major cardiovascular complications

    Time frame: At biopsy or during study follow up after biopsy (expected average 60-months)

    3-point MACE: non fatal stroke, non fatal myocardial infarction, cardiovascular death

  14. Major infectious complications

    Time frame: At biopsy or during study follow up after biopsy (expected average 60-months)

    any major fungal, bacterial or viral infection

  15. Malignancy post transplantation

    Time frame: At biopsy or during study follow up after biopsy (expected average 60-months)

    any cancer type

  16. Kidney biopsy transcriptomic signature

    Time frame: At biopsy - based on collected tissue sample

    Based on bulk and/or spatial transcriptomic experiments

  17. Kidney cell type composition

    Time frame: At biopsy - based on collected tissue sample

    Cell type phenotyping of immune and kidney cell types

  18. Proteinomic signature

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

    mass spectrometry or spatial proteinomic results

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer SY Li, MBBS, FRACP

CONTACT

[email protected]

612 88905555

Philip J O'Connell, MBBS, FRACP

CONTACT

[email protected]

612 88905555

Sponsors and collaborators

Lead sponsor

Western Sydney Local Health District

Other

Registry information

Acronym: GEM-KiT

Important dates

Study start
2025
Primary completion
2030
Study completion
2035
First posted
Apr 15, 2024
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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