Western Sydney Kidney Injury Biopsy Study (WESTKiD)

Western Sydney Local Health District

Status: Not yet enrolling

Conditions: Kidney Injury

Treatments: Other: Retrospective review of histological features

Study type: Observational

Funder types: Other

Identifiers

NCT06254677

WESTKiD

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,000 participants in 3 patient groups

Acute tubular injury (ATI) only

Description:

Kidney biopsy with features of acute tubular injury only, no other pathology detected

Treatment:

Other: Retrospective review of histological features

Concurrent diagnosis of acute tubular injury with any other pathology

Description:

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.

Treatment:

Other: Retrospective review of histological features

Biopsies with no acute tubular injury (neg control)

Description:

Kidney biopsy with any diagnosis other than (no features of) acute tubular injury

Treatment:

Other: Retrospective review of histological features