Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06254677

Western Sydney Kidney Injury Biopsy Study

The investigators aim to develop a clinically validated, histological acute tubular injury (ATI) scoring system to help improve diagnostic precision and predict clinical outcomes following ATI.

To use an unbiased, data-driven approach, correlating pathological features (including digital pathology), key signatures using spatial technologies (transcriptomics or proteinomics) with relevant clinical outcomes. Spatial technologies (including spatial transcriptomics and spatial proteinomics) allow the use of 'precision pathology' to study the critical link between molecular characteristics to histological structure.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Kidney Injury

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

The study is an investigator-led, retrospective, observational cohort study. This study is intended to be in perpetuity and there will be regular reporting to the local HREC (Western Sydney Local Health District, WSLHD)

Primary aim: the investigators aim to derive a clinically validated scoring system for acute kidney injury and iteratively improve its performance through machine learning algorithms over time.

Secondary aims:

  • Derive a spatially resolved transcriptomic signature of acute kidney injury (AKI)
  • Derive accurate transcriptomic signatures aligned with key cell types in AKI
  • Derive unique gene signatures to differentiate different causes of AKI

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

  • Had a kidney transplant at any time after the year 2000
  • Kidney biopsy sample sent to Westmead Hospital for clinical interpretation
  • Have information regarding kidney function available.

This will include groups with

  • Acute tubular injury (ATI) only
  • ATI concurrently diagnosed with any other pathology on biopsy
  • Biopsies with no ATI (negative control)

Collection of health related data will be through review of primary medical records to improve the diagnostic utility of kidney biopsies performed to evaluate the cause of AKI.

The investigators will also be requesting waiver of consent for access to histopathology slides and residual kidney tissue

  • Histopathology slides, which were created and analysed as part of routine clinical care.
  • Residual kidney tissue, either as paraffin blocks or fresh frozen tissue

Who can participate

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

Inclusion criteria

  • Had a kidney biopsy (native kidney or transplant kidney included) after year 2000
  • Kidney biopsy sample sent to Westmead Hospital for clinical interpretation

Exclusion criteria

  • Patients who have never had a kidney biopsy performed
  • Biopsy sample not available at Westmead Hospital
  • No information on kidney function (serum creatinine or eGFR)

Treatment and study plan

Retrospective review of histological features

Other

Correlate histopathology characteristics of acute kidney injury with molecular signatures, kidney function and aetiology of acute kidney injury to derive clinically validated scoring system for acute kidney injury and acute tubular injury

Primary outcomes

  1. Histopathology characteristics of acute tubular injury (ATI)

    Time frame: Specific for the biopsy/tissue, no time frame after

    Biopsy features including tubular dilatation, interstitial oedema, epithelial vacuolization and disrupted brush border integrity

  2. Kidney function

    Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)

    Kidney function based on blood tests collected from routine clinical care

  3. Correlation of biopsy findings with kidney function at time of biopsy and longitudinally

    Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)

    Molecular signatures of injury

Secondary outcomes

  1. Surrogate end point of kidney function

    Time frame: During study follow up after biopsy (expected average 12-months)

    eGFR slope

  2. Albuminuria

    Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)

    urine albumin to creatinine ratio

  3. Time to renal recovery

    Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)

    Kidney function return to baseline - based on any historical results before the biopsy date

  4. Time to kidney failure

    Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)

    Deterioration (or no recovery) in kidney function where dialysis or transplantation is needed to sustain life

  5. Chronic kidney disease

    Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)

    Deterioration (or without full recovery) in kidney function where chronic kidney disease is diagnosed based on clinical criteria

  6. Response to treatment

    Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)

    Response to non-supportive therapy (eg steroids)

  7. Genomic signatures

    Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)

    Transcriptomics (RNA) and microRNA (miRNA) extracted from the kidney biopsy

  8. Cell types

    Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)

    Detection of immune or kidney cell types on kidney biopsy

Sponsors and collaborators

Lead sponsor

Western Sydney Local Health District

Other

Registry information

Acronym: WESTKiD

Important dates

Study start
2024
Primary completion
2035
Study completion
2040
First posted
Feb 12, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.