Western Sydney Kidney Injury Biopsy Study
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: Retrospective review of histological features.
- Who it may be relevant to
- Registry conditions: Kidney Injury. 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
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.
Detailed description
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
1. Had a kidney transplant at any time after the year 2000 2. Kidney biopsy sample sent to Westmead Hospital for clinical interpretation 3. Have information regarding kidney function available.
This will include groups with
1. Acute tubular injury (ATI) only 2. ATI concurrently diagnosed with any other pathology on biopsy 3. 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
Interventions
- Other Retrospective review of histological features
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 outcome measures
- Histopathology characteristics of acute tubular injury (ATI) [Time frame: Specific for the biopsy/tissue, no time frame after]
- Kidney function [Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)]
- 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)]
Secondary outcome measures (8)
- Surrogate end point of kidney function [Time frame: During study follow up after biopsy (expected average 12-months)]
- Albuminuria [Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)]
- Time to renal recovery [Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)]
- Time to kidney failure [Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)]
- Chronic kidney disease [Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)]
- Response to treatment [Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)]
- Genomic signatures [Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)]
- Cell types [Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)]
Eligibility criteria
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)
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
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06254677 · WESTKiD