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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
Date last updated
24/04/2024

Titles & IDs
Public title
Spatial Transcriptomics in Kidney Transplantation
Scientific title
Spatial Transcriptomics in Kidney Transplantation
Secondary ID [1] 0 0
SPACE-KIT
Universal Trial Number (UTN)
Trial acronym
SPACE-KiT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transplant Complication 0 0
Kidney Injury 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Kidney biopsy features
Timepoint [1] 0 0
At biopsy or during study follow up following biopsy during study (expected 12-months)
Primary outcome [2] 0 0
Kidney biopsy transcriptomic signature
Timepoint [2] 0 0
At biopsy - based on collected tissue sample
Primary outcome [3] 0 0
Kidney cell type composition
Timepoint [3] 0 0
At biopsy - based on collected tissue sample
Secondary outcome [1] 0 0
All cause graft loss
Timepoint [1] 0 0
At biopsy or during study follow up after biopsy (expected average over 60-months)
Secondary outcome [2] 0 0
Death censored graft loss (DCGL)
Timepoint [2] 0 0
At biopsy or during study follow up after biopsy (expected average over 60-months)
Secondary outcome [3] 0 0
Treatment resistant rejection
Timepoint [3] 0 0
At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary outcome [4] 0 0
Delayed graft function (DGF)
Timepoint [4] 0 0
At biopsy or during study follow up after biopsy (within 7 days of transplantation)
Secondary outcome [5] 0 0
Biopsy evidence of borderline rejection
Timepoint [5] 0 0
At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary outcome [6] 0 0
Biopsy proven acute rejection
Timepoint [6] 0 0
At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary outcome [7] 0 0
Chronic rejection
Timepoint [7] 0 0
At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary outcome [8] 0 0
Interstitial fibrosis scores (IFTA)
Timepoint [8] 0 0
At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary outcome [9] 0 0
BK virus associated nephropathy
Timepoint [9] 0 0
At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary outcome [10] 0 0
Kidney function
Timepoint [10] 0 0
At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary outcome [11] 0 0
Albuminuria
Timepoint [11] 0 0
At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary outcome [12] 0 0
Surrogate end-points
Timepoint [12] 0 0
At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary outcome [13] 0 0
Donor to recipient mismatches
Timepoint [13] 0 0
At biopsy or during study follow up after biopsy (expected average 12-months)
Secondary outcome [14] 0 0
Proteinomic signature
Timepoint [14] 0 0
At biopsy or during study follow up after biopsy (expected average 12-months)

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)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2035
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT06288425
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jen Li, FRACP
Address 0 0
Westmead Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06288425