Kidney InjuryWESTKiDNCT06254677
Western Sydney Kidney Injury Biopsy Study
An observational study of Kidney Injury, run by Western Sydney Local Health District at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Injury
- What is being tested?
- Retrospective review of histological features
- How many people
- 1,000 participants
- Where
- 1 siteAustralia
- Study dates
- 1 May 2024to 1 Jan 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients who had a kidney biopsy performed for any clinical indication, with biopsy sample sent to Westmead Hospital for review
Who may be able to join
- Had a kidney biopsy (native kidney or transplant kidney included) after year 2000
- Kidney biopsy sample sent to Westmead Hospital for clinical interpretation
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this 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.
Read the 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
- 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
- Conditions
- Kidney Injury
- Being tested
- Retrospective review of histological features
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective review of histological featuresOther
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
| Study group | Role | What they receive |
|---|---|---|
| Acute tubular injury (ATI) only | Kidney biopsy with features of acute tubular injury only, no other pathology detected Receives: Other: Retrospective review of histological features | |
| Concurrent diagnosis of acute tubular injury with any other pathology | 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. Receives: Other: Retrospective review of histological features | |
| Biopsies with no acute tubular injury (neg control) | Kidney biopsy with any diagnosis other than (no features of) acute tubular injury Receives: Other: Retrospective review of histological features |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathology characteristics of acute tubular injury (ATI)
Biopsy features including tubular dilatation, interstitial oedema, epithelial vacuolization and disrupted brush border integrity
Measured: Specific for the biopsy/tissue, no time frame after
Kidney function
Kidney function based on blood tests collected from routine clinical care
Measured: 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
Measured: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Secondary outcomes (8)
Surrogate end point of kidney function
eGFR slope
Measured: During study follow up after biopsy (expected average 12-months)
Albuminuria
urine albumin to creatinine ratio
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 May 2024
- Primary completion1 Jan 2035 (estimated)
- Study completion1 Jan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Li, Western Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254677
- Sponsor's protocol ID
- WESTKiD
- Acronym
- WESTKiD
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Western Sydney Kidney Injury Biopsy Study
- ClinicalTrials.gov ID
- NCT06254677
- Acronym / sponsor ID
- WESTKiD / WESTKiD
- Conditions
- Kidney Injury
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jan 2035 (estimated)
- Study completion
- 1 Jan 2040 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute tubular injury (ATI) only | – | Other: Retrospective review of histological featuresKidney biopsy with features of acute tubular injury only, no other pathology detected |
| Concurrent diagnosis of acute tubular injury with any other pathology | – | Other: Retrospective review of histological featuresKidney 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. |
| Biopsies with no acute tubular injury (neg control) | – | Other: Retrospective review of histological featuresKidney biopsy with any diagnosis other than (no features of) acute tubular injury |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who had a kidney biopsy performed for any clinical indication, with biopsy sample sent to Westmead Hospital for review
Key inclusion criteria (2 listed)
- Had a kidney biopsy (native kidney or transplant kidney included) after year 2000
- Kidney biopsy sample sent to Westmead Hospital for clinical interpretation
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective review of histological featuresCorrelate 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 | Other | Acute tubular injury (ATI) only, Biopsies with no acute tubular injury (neg control), Concurrent diagnosis of acute tubular injury with any other pathology |
Primary outcome
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
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
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
8 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Injury, run by Western Sydney Local Health District at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathology characteristics of acute tubular injury (ATI) (time frame: Specific for the biopsy/tissue, no time frame after). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.