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Enrolling by Invitation

NCT Number: NCT06288425

Spatial Transcriptomics in Kidney Transplantation

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

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Key information

Conditions

Transplant Complication Kidney Injury

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

About this study

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:

  • All cause graft loss
  • Death censored graft loss
  • Treatment resistant rejection
  • Delayed graft function (DGF)
  • Biopsy evidence of borderline rejection based on current Banff scoring system
  • Biopsy proven acute rejection - T-cell mediated (TCMR), antibody-mediated (ABMR), mixed
  • Chronic rejection - acute or inactive
  • Interstitial fibrosis scores (IFTA) on kidney biopsy on any biopsies
  • Chronic transplant glomerulopathy on kidney biopsy on any biopsies
  • Development of BK virus associated nephropathy at any time
  • Recurrent disease (original cause of kidney failure) post transplantation at any time
  • Kidney function with serum creatinine, estimated or measured glomerular filtration rate (GFR)
  • Development of albuminuria
  • Surrogate end-points - eGFR slope and iBOX(TM) score
  • Donor-recipient HLA and non-HLA genomic mismatches
  • Recipient proteinomic expression profile

Who can participate

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

Non Interventional

Other

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

Primary outcomes

  1. Kidney biopsy features

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

    Based on the pathology subtype at original diagnosis

  2. Kidney biopsy transcriptomic signature

    Time frame: At biopsy - based on collected tissue sample

    Based on bulk and/or spatial transcriptomic experiments

  3. Kidney cell type composition

    Time frame: At biopsy - based on collected tissue sample

    Cell type phenotyping of immune and kidney cell types

Secondary outcomes

  1. All cause graft loss

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

    Graft loss - death censored and death with functioning graft

  2. Death censored graft loss (DCGL)

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

    Graft loss - excluding cases of death with functioning graft

  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. Delayed graft function (DGF)

    Time frame: At biopsy or during study follow up after biopsy (within 7 days of transplantation)

    Need for dialysis within 7 days of transplantation

  5. Biopsy evidence of borderline rejection

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

    Based on current Banff scoring system - features of inflammation but not meeting acute rejection criteria

  6. Biopsy proven acute rejection

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

    Based on current Banff scoring system - features of acute rejection, , any subtype

  7. Chronic rejection

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

    Based on current Banff scoring system with features of chronic rejection, any subtype

  8. Interstitial fibrosis scores (IFTA)

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

    features of interstitial fibrosis scores on the biopsy, with or without concurrent inflammation or tubulitis in the scarred areas on biopsy

  9. BK virus associated nephropathy

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

    biopsy evidence of positive SV40 stain in tubules

  10. Kidney function

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

    Based on blood creatinine, eGFR

  11. Albuminuria

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

    Based on urine albumin to creatinine ratio

  12. Surrogate end-points

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

    eGFR slow and iBOX score

  13. Donor to recipient mismatches

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

    genomic/molecular level, HLA and non-HLA

  14. Proteinomic signature

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

    mass spectrometry or spatial proteinomic changes between groups

Sponsors and collaborators

Lead sponsor

Western Sydney Local Health District

Other

Registry information

Acronym: SPACE-KiT

Important dates

Study start
2024
Primary completion
2030
Study completion
2035
First posted
Mar 1, 2024
Registry last updated
Apr 24, 2024

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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