Spatial Transcriptomics in Kidney Transplantation
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: Non interventional.
- Who it may be relevant to
- Registry conditions: Transplant Complication, Kidney Injury. Basic parameters: 18 years — 75 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
- Australia
- 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
The study is an investigator-led, prospective, longitudinal, observational cohort study. The central hypothesis for this study is that spatial data will reveal new insights to immune cell function and local interactions within the kidney tissue to better predict important clinical outcomes. Investigators aspire to establish a prospective, longitudinal cohort to improve the diagnosis and management of kidney transplant rejection using precision pathology. By utilising new spatial technologies, the investigators aim to: * Derive a spatially resolved transcriptomic signature of kidney transplant rejection subtypes * Derive accurate transcriptomic signatures aligned with key cell types within the transplant kidney * Develop refinements to histological kidney rejection diagnostic and scoring classification * Correlate of spatial and refined biopsy scoring features to clinically important outcomes
Detailed description
Primary outcomes: The correlation of kidney transplant rejection subtypes with transcriptomic, spatial and cell-type features
Secondary outcomes: Correlation of the refined biopsy scoring criteria and transcriptomics signatures with:
1. All cause graft loss 2. Death censored graft loss 3. Treatment resistant rejection 4. Delayed graft function (DGF) 5. Biopsy evidence of borderline rejection based on current Banff scoring system 6. Biopsy proven acute rejection - T-cell mediated (TCMR), antibody-mediated (ABMR), mixed 7. Chronic rejection - acute or inactive 8. Interstitial fibrosis scores (IFTA) on kidney biopsy on any biopsies 9. Chronic transplant glomerulopathy on kidney biopsy on any biopsies 10. Development of BK virus associated nephropathy at any time 11. Recurrent disease (original cause of kidney failure) post transplantation at any time 12. Kidney function with serum creatinine, estimated or measured glomerular filtration rate (GFR) 13. Development of albuminuria 14. Surrogate end-points - eGFR slope and iBOX(TM) score 15. Donor-recipient HLA and non-HLA genomic mismatches 16. Recipient proteinomic expression profile
Interventions
- Other Non interventional
Non interventional. Review of clinical, biopsy (histopathological and molecular) features associated with rejection and non-rejection pathology diagnosis
Primary outcome measures
- Kidney biopsy features [Time frame: At biopsy or during study follow up following biopsy during study (expected 12-months)]
- Kidney biopsy transcriptomic signature [Time frame: At biopsy - based on collected tissue sample]
- Kidney cell type composition [Time frame: At biopsy - based on collected tissue sample]
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 censored graft loss (DCGL) [Time frame: At biopsy or during study follow up after biopsy (expected average over 60-months)]
- Treatment resistant rejection [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
- Delayed graft function (DGF) [Time frame: At biopsy or during study follow up after biopsy (within 7 days of transplantation)]
- Biopsy evidence of borderline rejection [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
- Biopsy proven acute rejection [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
- Chronic rejection [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
- Interstitial fibrosis scores (IFTA) [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
- BK virus associated nephropathy [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
- Kidney function [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
- Albuminuria [Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)]
- Surrogate end-points [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.
Study design
- Observational model
- Cohort
Study locations
Australia · 1 center
- Westmead Hospital — Westmead
Identifiers
NCT: NCT06288425 · SPACE-KIT