Western Sydney Kidney Injury Biopsy Study

Kidney Injury Clinical Trial

— WESTKiD  

Official title:

Western Sydney Kidney Injury Biopsy Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06254677
• Other study ID #: WESTKiD
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: January 1, 2040

Study information

• Verified date: April 2024
• Source: Western Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: January 1, 2040
• Est. primary completion date: January 1, 2035
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Had a kidney biopsy (native kidney or transplant kidney included) after year 2000

2. Kidney biopsy sample sent to Westmead Hospital for clinical interpretation

Exclusion Criteria:

1. Patients who have never had a kidney biopsy performed

2. Biopsy sample not available at Westmead Hospital

3. No information on kidney function (serum creatinine or eGFR)

Related Conditions & MeSH terms

• Kidney Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western Sydney Local Health District

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histopathology characteristics of acute tubular injury (ATI)	Biopsy features including tubular dilatation, interstitial oedema, epithelial vacuolization and disrupted brush border integrity	Specific for the biopsy/tissue, no time frame after
Primary	Kidney function	Kidney function based on blood tests collected from routine clinical care	At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Primary	Correlation of biopsy findings with kidney function at time of biopsy and longitudinally	Molecular signatures of injury	At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Secondary	Surrogate end point of kidney function	eGFR slope	During study follow up after biopsy (expected average 12-months)
Secondary	Albuminuria	urine albumin to creatinine ratio	At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Secondary	Time to renal recovery	Kidney function return to baseline - based on any historical results before the biopsy date	At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Secondary	Time to kidney failure	Deterioration (or no recovery) in kidney function where dialysis or transplantation is needed to sustain life	At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Secondary	Chronic kidney disease	Deterioration (or without full recovery) in kidney function where chronic kidney disease is diagnosed based on clinical criteria	At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Secondary	Response to treatment	Response to non-supportive therapy (eg steroids)	At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Secondary	Genomic signatures	Transcriptomics (RNA) and microRNA (miRNA) extracted from the kidney biopsy	At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)
Secondary	Cell types	Detection of immune or kidney cell types on kidney biopsy	At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)