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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06288425
Registration number
NCT06288425
Ethics application status
Date submitted
3/02/2024
Date registered
1/03/2024
Titles & IDs
Public title
Spatial Transcriptomics in Kidney Transplantation
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Scientific title
Spatial Transcriptomics in Kidney Transplantation
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Secondary ID [1]
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SPACE-KIT
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Universal Trial Number (UTN)
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Trial acronym
SPACE-KiT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Transplant Complication
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Kidney Injury
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Non interventional
No rejection, normal biopsy (controls) - Normal biopsy - no acute tubular injury (ATI), rejection or any other pathology
Acute kidney injury without evidence of rejection - Biopsy features of acute tubular injury but no evidence of rejection
Subclinical Rejection - Biopsy features of injury and inflammation but not meeting current diagnostic criteria for acute or chronic rejection
Acute rejection - Biopsy features of T-cell mediated, antibody-mediated, or mixed rejection
Isolated vascular rejection - Biopsy features of inflammation in the blood vessels only
Isolated glomerulitis - Biopsy features of inflammation in the glomeruli only
Chronic (active) rejection - Biopsy features of chronic rejection - T-cell, antibody or mixed types
BK virus associated nephropathy (BKVAN) - Biopsy features of SV40 positive staining in tubules to diagnose BKVAN
Other interventions: Non interventional
Non interventional. Review of clinical, biopsy (histopathological and molecular) features associated with rejection and non-rejection pathology diagnosis
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Kidney biopsy features
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Assessment method [1]
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Based on the pathology subtype at original diagnosis
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Timepoint [1]
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At biopsy or during study follow up following biopsy during study (expected 12-months)
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Primary outcome [2]
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Kidney biopsy transcriptomic signature
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Assessment method [2]
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Based on bulk and/or spatial transcriptomic experiments
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Timepoint [2]
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At biopsy - based on collected tissue sample
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Primary outcome [3]
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Kidney cell type composition
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Assessment method [3]
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Cell type phenotyping of immune and kidney cell types
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Timepoint [3]
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At biopsy - based on collected tissue sample
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Secondary outcome [1]
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All cause graft loss
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Assessment method [1]
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Graft loss - death censored and death with functioning graft
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Timepoint [1]
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At biopsy or during study follow up after biopsy (expected average over 60-months)
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Secondary outcome [2]
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Death censored graft loss (DCGL)
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Assessment method [2]
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Graft loss - excluding cases of death with functioning graft
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Timepoint [2]
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At biopsy or during study follow up after biopsy (expected average over 60-months)
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Secondary outcome [3]
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Treatment resistant rejection
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Assessment method [3]
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Persistent rejection despite additional glucocorticoids and/or upscaling of maintenance immunosuppression
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Timepoint [3]
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At biopsy or during study follow up after biopsy (expected average 12-months)
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Secondary outcome [4]
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Delayed graft function (DGF)
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Assessment method [4]
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Need for dialysis within 7 days of transplantation
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Timepoint [4]
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At biopsy or during study follow up after biopsy (within 7 days of transplantation)
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Secondary outcome [5]
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Biopsy evidence of borderline rejection
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Assessment method [5]
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Based on current Banff scoring system - features of inflammation but not meeting acute rejection criteria
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Timepoint [5]
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At biopsy or during study follow up after biopsy (expected average 12-months)
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Secondary outcome [6]
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Biopsy proven acute rejection
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Assessment method [6]
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Based on current Banff scoring system - features of acute rejection, , any subtype
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Timepoint [6]
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At biopsy or during study follow up after biopsy (expected average 12-months)
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Secondary outcome [7]
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Chronic rejection
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Assessment method [7]
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Based on current Banff scoring system with features of chronic rejection, any subtype
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Timepoint [7]
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At biopsy or during study follow up after biopsy (expected average 12-months)
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Secondary outcome [8]
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Interstitial fibrosis scores (IFTA)
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Assessment method [8]
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features of interstitial fibrosis scores on the biopsy, with or without concurrent inflammation or tubulitis in the scarred areas on biopsy
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Timepoint [8]
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At biopsy or during study follow up after biopsy (expected average 12-months)
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Secondary outcome [9]
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BK virus associated nephropathy
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Assessment method [9]
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biopsy evidence of positive SV40 stain in tubules
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Timepoint [9]
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At biopsy or during study follow up after biopsy (expected average 12-months)
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Secondary outcome [10]
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Kidney function
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Assessment method [10]
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Based on blood creatinine, eGFR
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Timepoint [10]
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At biopsy or during study follow up after biopsy (expected average 12-months)
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Secondary outcome [11]
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Albuminuria
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Assessment method [11]
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Based on urine albumin to creatinine ratio
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Timepoint [11]
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At biopsy or during study follow up after biopsy (expected average 12-months)
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Secondary outcome [12]
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Surrogate end-points
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Assessment method [12]
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eGFR slow and iBOX score
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Timepoint [12]
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At biopsy or during study follow up after biopsy (expected average 12-months)
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Secondary outcome [13]
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Donor to recipient mismatches
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Assessment method [13]
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genomic/molecular level, HLA and non-HLA
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Timepoint [13]
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At biopsy or during study follow up after biopsy (expected average 12-months)
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Secondary outcome [14]
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Proteinomic signature
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Assessment method [14]
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mass spectrometry or spatial proteinomic changes between groups
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Timepoint [14]
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At biopsy or during study follow up after biopsy (expected average 12-months)
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Eligibility
Key inclusion criteria
All participants included in the study must be age = 18 years old at time of enrolment and
1. able to provide informed consent (interpreter permitted) for enrolment
2. consenting to longitudinal follow up (can withdraw post enrolment)
3. consenting to provide samples for biobanking, including blood, urine, faecal and/or kidney biopsy tissue (collected prospectively, separate to routine care)
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients will be excluded from the study if they are
1. unable (or unwilling) to provide consent, or
2. have life-expectancy less than 6-months, or
3. have received a haematopoietic stem cell transplant in the past 5 years.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/04/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2035
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Funding & Sponsors
Primary sponsor type
Other
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Name
Western Sydney Local Health District
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The study is an investigator-led, prospective, longitudinal, observational cohort study. The central hypothesis for this study is that spatial data will reveal new insights to immune cell function and local interactions within the kidney tissue to better predict important clinical outcomes. Investigators aspire to establish a prospective, longitudinal cohort to improve the diagnosis and management of kidney transplant rejection using precision pathology. By utilising new spatial technologies, the investigators aim to: * Derive a spatially resolved transcriptomic signature of kidney transplant rejection subtypes * Derive accurate transcriptomic signatures aligned with key cell types within the transplant kidney * Develop refinements to histological kidney rejection diagnostic and scoring classification * Correlate of spatial and refined biopsy scoring features to clinically important outcomes
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Trial website
https://clinicaltrials.gov/study/NCT06288425
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jen Li, FRACP
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Address
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Westmead Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06288425