Western Sydney Kidney Injury Biopsy Study
ConditionKidney Injury
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorWestern Sydney Local Health District
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Had a kidney biopsy (native kidney or transplant kidney included) after year 2000
Kidney biopsy sample sent to Westmead Hospital for clinical interpretation
Disqualifiers
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)
Trial population
Patients who had a kidney biopsy performed for any clinical indication, with biopsy sample sent to Westmead Hospital for review
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Retrospective review of histological features
Other interventionCorrelate 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
Treatment groups
1,000 Participants
are divided into 3 treatment groupsGroup A: Acute tubular injury (ATI) only1 intervention
Group B: Concurrent diagnosis of acute tubular injury with any other pathology1 intervention
Group C: Biopsies with no acute tubular injury (neg control)1 intervention
Trial outcomes
Primary outcomes
1
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 after2
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)3
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)Secondary outcomes
1
Surrogate end point of kidney function
eGFR slope
Time frame
During study follow up after biopsy (expected average 12-months)2
Albuminuria
urine albumin to creatinine ratio
Time frame
At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)3
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)4
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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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