Transplant ComplicationSPACE-KiTNCT06288425
Spatial Transcriptomics in Kidney Transplantation
An observational study of Transplant Complication and Kidney Injury, run by Western Sydney Local Health District at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transplant Complication, Kidney Injury
- What is being tested?
- Non interventional
- How many people
- 500 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Apr 2024to 1 Jan 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Kidney transplant (or kidney-pancreas transplant) recipients consenting to this study.
Who may be able to join
- All participants included in the study must be age ≥ 18 years old at time of enrolment and
- able to provide informed consent (interpreter permitted) for enrolment
- consenting to longitudinal follow up (can withdraw post enrolment)
- consenting to provide samples for biobanking, including blood, urine, faecal and/or kidney biopsy tissue (collected prospectively, separate to routine care)
Who cannot join
- Patients will be excluded from the study if they are
- unable (or unwilling) to provide consent, or
- have life-expectancy less than 6-months, or
- have received a haematopoietic stem cell transplant in the past 5 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
Read the detailed description
Primary outcomes: The correlation of kidney transplant rejection subtypes with transcriptomic, spatial and cell-type features
Secondary outcomes: Correlation of the refined biopsy scoring criteria and transcriptomics signatures with:
- All cause graft loss
- Death censored graft loss
- Treatment resistant rejection
- Delayed graft function (DGF)
- Biopsy evidence of borderline rejection based on current Banff scoring system
- Biopsy proven acute rejection - T-cell mediated (TCMR), antibody-mediated (ABMR), mixed
- Chronic rejection - acute or inactive
- Interstitial fibrosis scores (IFTA) on kidney biopsy on any biopsies
- Chronic transplant glomerulopathy on kidney biopsy on any biopsies
- Development of BK virus associated nephropathy at any time
- Recurrent disease (original cause of kidney failure) post transplantation at any time
- Kidney function with serum creatinine, estimated or measured glomerular filtration rate (GFR)
- Development of albuminuria
- Surrogate end-points - eGFR slope and iBOX(TM) score
- Donor-recipient HLA and non-HLA genomic mismatches
- Recipient proteinomic expression profile
- Conditions
- Transplant Complication, Kidney Injury
- Being tested
- Non interventional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventionalOther
Non interventional. Review of clinical, biopsy (histopathological and molecular) features associated with rejection and non-rejection pathology diagnosis
| Study group | Role | What they receive |
|---|---|---|
| No rejection, normal biopsy (controls) | Normal biopsy - no acute tubular injury (ATI), rejection or any other pathology Receives: Other: Non interventional | |
| Acute kidney injury without evidence of rejection | Biopsy features of acute tubular injury but no evidence of rejection Receives: Other: Non interventional | |
| Subclinical Rejection | Biopsy features of injury and inflammation but not meeting current diagnostic criteria for acute or chronic rejection Receives: Other: Non interventional | |
| Acute rejection | Biopsy features of T-cell mediated, antibody-mediated, or mixed rejection Receives: Other: Non interventional | |
| Isolated vascular rejection | Biopsy features of inflammation in the blood vessels only Receives: Other: Non interventional | |
| Isolated glomerulitis | Biopsy features of inflammation in the glomeruli only Receives: Other: Non interventional | |
| Chronic (active) rejection | Biopsy features of chronic rejection - T-cell, antibody or mixed types Receives: Other: Non interventional | |
| BK virus associated nephropathy (BKVAN) | Biopsy features of SV40 positive staining in tubules to diagnose BKVAN Receives: Other: Non interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney biopsy features
Based on the pathology subtype at original diagnosis
Measured: At biopsy or during study follow up following biopsy during study (expected 12-months)
Kidney biopsy transcriptomic signature
Based on bulk and/or spatial transcriptomic experiments
Measured: At biopsy - based on collected tissue sample
Kidney cell type composition
Cell type phenotyping of immune and kidney cell types
Measured: At biopsy - based on collected tissue sample
Secondary outcomes (14)
All cause graft loss
Graft loss - death censored and death with functioning graft
Measured: At biopsy or during study follow up after biopsy (expected average over 60-months)
Death censored graft loss (DCGL)
Graft loss - excluding cases of death with functioning graft
Measured: At biopsy or during study follow up after biopsy (expected average over 60-months)
Treatment resistant rejection
Persistent rejection despite additional glucocorticoids and/or upscaling of maintenance immunosuppression
Measured: At biopsy or during study follow up after biopsy (expected average 12-months)
Delayed graft function (DGF)
Need for dialysis within 7 days of transplantation
Measured: At biopsy or during study follow up after biopsy (within 7 days of transplantation)
Biopsy evidence of borderline rejection
Based on current Banff scoring system - features of inflammation but not meeting acute rejection criteria
Measured: At biopsy or during study follow up after biopsy (expected average 12-months)
Biopsy proven acute rejection
Based on current Banff scoring system - features of acute rejection, , any subtype
Measured: At biopsy or during study follow up after biopsy (expected average 12-months)
Chronic rejection
Based on current Banff scoring system with features of chronic rejection, any subtype
Measured: At biopsy or during study follow up after biopsy (expected average 12-months)
Interstitial fibrosis scores (IFTA)
features of interstitial fibrosis scores on the biopsy, with or without concurrent inflammation or tubulitis in the scarred areas on biopsy
Measured: At biopsy or during study follow up after biopsy (expected average 12-months)
BK virus associated nephropathy
biopsy evidence of positive SV40 stain in tubules
Measured: At biopsy or during study follow up after biopsy (expected average 12-months)
Kidney function
Based on blood creatinine, eGFR
Measured: At biopsy or during study follow up after biopsy (expected average 12-months)
Albuminuria
Based on urine albumin to creatinine ratio
Measured: At biopsy or during study follow up after biopsy (expected average 12-months)
Surrogate end-points
eGFR slow and iBOX score
Measured: At biopsy or during study follow up after biopsy (expected average 12-months)
Donor to recipient mismatches
genomic/molecular level, HLA and non-HLA
Measured: At biopsy or during study follow up after biopsy (expected average 12-months)
Proteinomic signature
mass spectrometry or spatial proteinomic changes between groups
Measured: At biopsy or during study follow up after biopsy (expected average 12-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start3 Apr 2024
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Li, Western Sydney Local Health District
- Investigators
- Jen Li, FRACP, Principal investigator, Westmead Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288425
- Sponsor's protocol ID
- SPACE-KIT
- Acronym
- SPACE-KiT
- Status last verified
- Apr 2024
- First submitted
- 3 Feb 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Transcriptomics in Kidney Transplantation
- ClinicalTrials.gov ID
- NCT06288425
- Acronym / sponsor ID
- SPACE-KiT / SPACE-KIT
- Conditions
- Transplant Complication, Kidney Injury
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Primary outcomes: The correlation of kidney transplant rejection subtypes with transcriptomic, spatial and cell-type features
Secondary outcomes: Correlation of the refined biopsy scoring criteria and transcriptomics signatures with:
- All cause graft loss
- Death censored graft loss
- Treatment resistant rejection
- Delayed graft function (DGF)
- Biopsy evidence of borderline rejection based on current Banff scoring system
- Biopsy proven acute rejection - T-cell mediated (TCMR), antibody-mediated (ABMR), mixed
- Chronic rejection - acute or inactive
- Interstitial fibrosis scores (IFTA) on kidney biopsy on any biopsies
- Chronic transplant glomerulopathy on kidney biopsy on any biopsies
- Development of BK virus associated nephropathy at any time
- Recurrent disease (original cause of kidney failure) post transplantation at any time
- Kidney function with serum creatinine, estimated or measured glomerular filtration rate (GFR)
- Development of albuminuria
- Surrogate end-points - eGFR slope and iBOX(TM) score
- Donor-recipient HLA and non-HLA genomic mismatches
- Recipient proteinomic expression profile
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| No rejection, normal biopsy (controls) | – | Other: Non interventionalNormal biopsy - no acute tubular injury (ATI), rejection or any other pathology |
| Acute kidney injury without evidence of rejection | – | Other: Non interventionalBiopsy features of acute tubular injury but no evidence of rejection |
| Subclinical Rejection | – | Other: Non interventionalBiopsy features of injury and inflammation but not meeting current diagnostic criteria for acute or chronic rejection |
| Acute rejection | – | Other: Non interventionalBiopsy features of T-cell mediated, antibody-mediated, or mixed rejection |
| Isolated vascular rejection | – | Other: Non interventionalBiopsy features of inflammation in the blood vessels only |
| Isolated glomerulitis | – | Other: Non interventionalBiopsy features of inflammation in the glomeruli only |
| Chronic (active) rejection | – | Other: Non interventionalBiopsy features of chronic rejection - T-cell, antibody or mixed types |
| BK virus associated nephropathy (BKVAN) | – | Other: Non interventionalBiopsy features of SV40 positive staining in tubules to diagnose BKVAN |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant (or kidney-pancreas transplant) recipients consenting to this study.
Key inclusion criteria (4 listed)
- All participants included in the study must be age ≥ 18 years old at time of enrolment and
- able to provide informed consent (interpreter permitted) for enrolment
- consenting to longitudinal follow up (can withdraw post enrolment)
- consenting to provide samples for biobanking, including blood, urine, faecal and/or kidney biopsy tissue (collected prospectively, separate to routine care)
Key exclusion criteria (4 listed)
- Patients will be excluded from the study if they are
- unable (or unwilling) to provide consent, or
- have life-expectancy less than 6-months, or
- have received a haematopoietic stem cell transplant in the past 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventionalNon interventional. Review of clinical, biopsy (histopathological and molecular) features associated with rejection and non-rejection pathology diagnosis | Other | Acute kidney injury without evidence of rejection, Acute rejection, BK virus associated nephropathy (BKVAN), Chronic (active) rejection, Isolated glomerulitis, Isolated vascular rejection, No rejection, normal biopsy (controls), Subclinical Rejection |
Primary outcome
Kidney biopsy features
Time frame: At biopsy or during study follow up following biopsy during study (expected 12-months)
Based on the pathology subtype at original diagnosis
Kidney biopsy transcriptomic signature
Time frame: At biopsy - based on collected tissue sample
Based on bulk and/or spatial transcriptomic experiments
Kidney cell type composition
Time frame: At biopsy - based on collected tissue sample
Cell type phenotyping of immune and kidney cell types
14 secondary outcomes
All cause graft loss
Time frame: At biopsy or during study follow up after biopsy (expected average over 60-months)
Death censored graft loss (DCGL)
Time frame: At biopsy or during study follow up after biopsy (expected average over 60-months)
Treatment resistant rejection
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Delayed graft function (DGF)
Time frame: At biopsy or during study follow up after biopsy (within 7 days of transplantation)
Biopsy evidence of borderline rejection
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Biopsy proven acute rejection
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Chronic rejection
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Interstitial fibrosis scores (IFTA)
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
BK virus associated nephropathy
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Kidney function
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Albuminuria
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Surrogate end-points
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Donor to recipient mismatches
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Proteinomic signature
Time frame: At biopsy or during study follow up after biopsy (expected average 12-months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Transplant Complication
Not yet recruitingObservational study
Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)
Transplant Associated Microangiopathy TAM, Transplant Complication
Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
RecruitingObservational study
The KidneyCARE (Community Access to Research Equity) Study
Chronic Kidney Disease, Dialysis
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jen Li, FRACP principal investigator
Westmead Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant Complication and Kidney Injury, run by Western Sydney Local Health District at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney biopsy features (time frame: At biopsy or during study follow up following biopsy during study (expected 12-months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.