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Not yet recruiting NCT06365411

GEnomic Medicine in Kidney Transplantation Study

— Observational Transplant Complication Kidney Transplant Rejection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biomarker discovery and validation - with focus on genomic biomarkers.
Who it may be relevant to
Registry conditions: Transplant Complication, Kidney Transplant Rejection. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Interventions

  • Diagnostic test Biomarker discovery and validation - with focus on genomic biomarkers
    Biomarker discovery and validation - with focus on genomic biomarkers

Primary outcome measures

  • Death censored graft loss (DCGL) [Time frame: At biopsy or during study follow up after biopsy (expected average over 60-months)]
  • Biopsy proven rejection (BPAR) [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
Secondary outcome measures (12)
  • All cause graft loss [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 [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
  • Hospital admission or emergency attendance [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
  • Delayed Graft Function (DGF) [Time frame: within the first 7 days post transplantation]
  • Kidney function [Time frame: Months 1, 3, 12, 24, 36, 48, 60, 120 post transplantation]
  • Albuminuria [Time frame: Months 1, 3, 12 any time after 12-months trnasplantation]
  • Surrogate end-point markers [Time frame: Months 3, 12, 24, 36, 48 and 60, 120 post transplantation]
  • Borderline rejeciton [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
  • 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)]
  • Recurrent disease [Time frame: At biopsy or during study follow up after biopsy (expected average 60-months)]
  • BK virus complications [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06365411 · GEM-KiT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗