An observational study in Kidney Injury, sponsored by Western Sydney Local Health District. Enrolling by invitation at 1 site in Australia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Western Sydney Local Health District · Observational
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.
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:
All participants included in the study must be age ≥ 18 years old at time of enrolment and
This will include groups with
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
Western Sydney Local Health District is the lead sponsor of 36 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who had a kidney biopsy performed for any clinical indication, with biopsy sample sent to Westmead Hospital for review
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Kidney biopsy with features of acute tubular injury only, no other pathology detected
Other: Retrospective review of histological features
Kidney biopsy with features of acute tubular injury AND other pathology. Non-ATI pathology includes but not limited to diagnosis of any type of glomerulonephritis, vasculitis, hereditary nephritis, thrombotic microangiopathy, kidney transplant rejection, podocytopathy, diabetic or hypertensive nephropathy, interstitial nephritis, pyelonephritis, amyloidosis, malignancy or paraneoplastic related kidney disease.
Other: Retrospective review of histological features
Kidney biopsy with any diagnosis other than (no features of) acute tubular injury
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
Histopathology characteristics of acute tubular injury (ATI)
Biopsy features including tubular dilatation, interstitial oedema, epithelial vacuolization and disrupted brush border integrity
Time frame: Specific for the biopsy/tissue, no time frame after
Kidney function
Kidney function based on blood tests collected from routine clinical care
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
Molecular signatures of injury
Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Surrogate end point of kidney function
eGFR slope
Time frame: During study follow up after biopsy (expected average 12-months)
Albuminuria
urine albumin to creatinine ratio
Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Time to renal recovery
Kidney function return to baseline - based on any historical results before the biopsy date
Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Time to kidney failure
Deterioration (or no recovery) in kidney function where dialysis or transplantation is needed to sustain life
Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Chronic kidney disease
Deterioration (or without full recovery) in kidney function where chronic kidney disease is diagnosed based on clinical criteria
Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Response to treatment
Response to non-supportive therapy (eg steroids)
Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Genomic signatures
Transcriptomics (RNA) and microRNA (miRNA) extracted from the kidney biopsy
Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Cell types
Detection of immune or kidney cell types on kidney biopsy
Time frame: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Western Sydney Local Health District