NCT06288425

Spatial Transcriptomics in Kidney Transplantation

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Western Sydney Local Health District · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

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

Conditions

• Transplant Complication
• Kidney Injury

Interventions

Type	Name	Description
OTHER	Non interventional	Non interventional. Review of clinical, biopsy (histopathological and molecular) features associated with rejection and non-rejection pathology diagnosis

Timeline

• Start date: 2024-04-03
• Primary completion: 2030-01-01
• Completion: 2035-01-01
• First posted: 2024-03-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: Australia