Western Sydney Kidney Injury Biopsy Study

NCT06254677 | Not Yet Recruiting

• 1 other identifier: WESTKiD
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Kidney Injury

Outcome Measures

Primary Outcomes (3)

• 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

• 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)

• 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 Outcomes (8)

• Surrogate end point of kidney function

  During study follow up after biopsy (expected average 12-months)

• Albuminuria

  At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)

• Time to renal recovery

  At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)

• Time to kidney failure

  At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)

• Chronic kidney disease

  At biopsy (time 0) or during study follow up after biopsy (expected average 12-months)

Study Arms (3)

Acute tubular injury (ATI) only

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

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.

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

Other: Retrospective review of histological features

Interventions

Retrospective review of histological features OTHER

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

Acute tubular injury (ATI) only; Biopsies with no acute tubular injury (neg control); Concurrent diagnosis of acute tubular injury with any other pathology

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who had a kidney biopsy performed for any clinical indication, with biopsy sample sent to Westmead Hospital for review

You may qualify if:

• Had a kidney biopsy (native kidney or transplant kidney included) after year 2000
• Kidney biopsy sample sent to Westmead Hospital for clinical interpretation

You may not qualify if:

• 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)

Sponsors & Collaborators

• Western Sydney Local Health District: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Access to histology slides: These slides are stored in the anatomical pathology department at Westmead Hospital/NSW Health Pathology. We will digitally scan these slides. Digital slides will be labelled with the study ID. Slides will be returned after scanning. Request access to kidney tissue blocks: This includes formalin-fixed, paraffin embedded (FFPE) kidney blocks, and fresh frozen kidney embedded in OCT. These are requested after clinical use and interpretation of the biopsy has been completed. The exact methodology will be determined by the available technology at the time (there is rapid advancement in imaging and molecular technologies) and the utility to achieve the objectives in the study. These include, but not limited to preparing slides for spatial transcriptomics (RNA-sequencing), single-cell extraction and RNA sequencing, spatial proteinomics, mass spectrometry/proteinomics, high plex immunohistochemistry, imaging mass cytometry

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CPI, Nephrologist and Transplant Physician

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: February 12, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): January 1, 2035
• Study Completion (Estimated): January 1, 2040
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share