Kidney TransplantHLA-ABNCT06025240
Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
An observational study of Kidney Transplant and Renal Transplant Failure, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess a new test to detect antibodies which may form following kidney transplant. These antibodies can be difficult to detect as they do not cause any symptoms but can lead to kidney damage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Renal Transplant Failure, Kidney Transplant Rejection
- What is being tested?
- cf-DNA, Immunological Events following renal transplant in older age and Determining Predictive Models for Post-transplant HLA-specific Antibody Formation
- How many people
- 282 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Oct 2023to 13 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. cf-DNA arm: Patients who have undergone a "high risk" renal transplant in our unit within the last 6-12 months will be retrospectively recruited to the study. 2. Older Age Immunological Events: Post-transplant patients prospectively recruited, irrespective of age, undergoing transplant to determine the overall frequency of immunological events and de novo HLA specific antibody formation. We will collect data on clinical outcomes and would look to compare the <60s with those 60 or older looking for a difference in immunological events beteween the 2 groups. 3. Predictive models: A subset of the cohort of recruits to the immunological factors in older age study will be used to determine machine learning algorithms of predictive factors for the development of de novo donor specific antibody.
Who may be able to join
- cf-DNA arm:
- Adult patients transplanted within 6-12 months (retrospective recruitment)
- Patients admitted for renal transplant or within the first 6 months following transplant (prospective recruitment)
- Patients must have capacity to provide informed consent
- Patients must have received a high-risk transplant defined as level 4 mismatch, cRF >20, second or subsequent transplant, ABO or HLA incompatible
- Older Age Immunological Events:
Show all 10Show fewer
- Any adult patient with capacity undergoing, or within 72 hours of, a renal transplant
- Predictive models:
- Any adult patient with capacity undergoing, or within 72 hours of, a renal transplant
- Unsensitized pre-transplant
Who cannot join
- cf-DNA arm:
- Transplanted for longer than 12 months;
- Low risk transplants;
- Patients lacking capacity;
- Older Age Immunological Events:
- Patients lacking capacity
Show all 11Show fewer
- Patients transplanted longer than 2 weeks
- Predictive models:
- Sensitised patients
- Patients lacking capacity
- Patients transplanted longer than 2 weeks
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Liverpool University Hospitals NHS Foundation Trust
Liverpool, Merseyside, L7 8YE
George E Nita, MBChB MSc MRCSEd, 01517062000, george.nita@liverpoolft.nhs.uk
Petra M Goldsmith, MBBChir PhD FRCS, 01517065550, petra.goldsmith@liverpoolft.nhs.uk
About this study
The purpose of this study is to assess a new test to detect antibodies which may form following kidney transplant. These antibodies can be difficult to detect as they do not cause any symptoms but can lead to kidney damage. A new blood test will be performed alongside existing antibody tests to see how well the test functions in comparison and to see how well it is able to distinguish between inflammation caused by antibodies and other sorts of inflammation such as a urinary tract infection. The investigators also want to determine whether it is predictable whom will develop antibodies after a transplant and use these results to change the current way patients are monitored for antibodies after receiving a transplant. In addition to this, the investigators want to establish if patients over 60 years of age are relatively protected against immunological events such as rejection compared to patients who are under 60 years of age. The results could potentially lead to using a different immunosuppression regime based on which population age group patients belong to and lowering the risks associated with these drugs.
Read the detailed description
Donor-derived cell-free DNA (dd-cfDNA)
Post-transplant monitoring for acute rejection in most centres, focuses on identification of a deterioration in graft function which may be totally asymptomatic. The current best practice to investigate a suspected rejection are renal graft biopsy with appropriate staining for complement component C4d and a serum single antigen bead (SAB) testing. This reactive approach to assessing and monitoring rejection, mainly driven by serial assessments of renal function to determine response to treatment, avoids the need for multiple invasive diagnostic tests such as biopsies, but it poses the risk of missing the early detection and treatment of rejection prior to an objective decline in function. A "creeping creatinine", where there are small but sustained increases in creatinine at sequential visits is relatively common and by the time a deterioration consistent with rejection is observed there can already have been significant tissue damage.
Donor-derived cell-free DNA (dd-cfDNA) has been described as a useful biomarker for graft injury secondary to rejection which can be evident in blood weeks to months prior to histological evidence of graft injury. dd-cfDNA levels are high in the immediate post-operative phase, although there is a sharp drop off to low baseline levels after a few days to two weeks making it a useful biomarker in all but the earliest rejection episode. Levels are much higher in antibody mediated rejection (ABMR) when compared to cellular rejection offering improvements in sensitivity when considering ABMR alone (85%) versus rejection of all aetiology (59%). The investigators believe it is important to correlate the findings of the dd-cfDNA sample with the other tests described, so that observations about the percentage dd-cfDNA found in different pathologies and the overall frequency of positive results can be made.
Immunological Factors in Older Age Renal Transplant and Longitudinal Donor Specific Antibodies (DSA) study
Older patients who undergo kidney transplant (KT) have better survival than those who remain on the waiting list. Nevertheless, outcomes are inferior to younger recipients and KT is often felt to be a predominantly quality of life intervention for older patients. Frailty may have a beneficial influence on the risk of post-transplant adverse immunological events and rejection episodes. If transplanted with good quality organs (all barring elderly deceased after circulatory death - DCD grafts), older kidney transplant recipients will have fewer rejection episodes than younger counterparts. The investigators conducted a retrospective cohort study of the outcomes for older age transplant recipients (>60) locally, to compare results before and after the change in allocation system which coincides with the COVID-19 pandemic. In this study, the investigators observed less favourable HLA-mismatching, a higher rate of re-intervention (operative or interventional radiology), higher rates of tertiary centre readmissions and higher 1-year mortality rates.
The previous post-transplant HLA-specific antibody work examined only the first positive sample post-transplant independent of pre-transplant sensitisation status. The investigators, thus, propose prospectively recruiting patients, irrespective of age, undergoing transplant to determine the overall frequency of immunological events and de novo HLA specific antibody formation. Given the importance of early detection and intervention of antibody mediated processes and optimising treatment protocols for frail patients, the investigators aim to expand the research interest in post-transplant antibody monitoring. The investigators, thus, propose prospectively recruiting patients, irrespective of age, undergoing transplant to determine the overall frequency of immunological events and de novo HLA specific antibody formation. Data on clinical outcomes will be collected and the investigators would look to compare the <60s with those 60 or older patients undergoing kidney transplant.
Determining Predictive Models for Post-transplant HLA-specific Antibody Formation
As an adjunct to the proposed study looking at the influence of age on immunological events, the investigators aim to examine the cohort as a whole to determine the differential clinical outcomes for patients with and without de novo HLA-specific antibody over time. An important part of this arm of the study will be to determine predictive models using machine learning methodology to determine those most at risk for the development of de-novo HLA specific antibody post-transplant.
- Conditions
- Kidney Transplant, Renal Transplant Failure, Kidney Transplant Rejection, Frailty, Kidney Transplant; Complications, Transplant Dysfunction
- Being tested
- cf-DNA, Immunological Events following renal transplant in older age, Determining Predictive Models for Post-transplant HLA-specific Antibody Formation
- Keywords
- kidney transplant, novel biomarkers, post-transplant antibodies, HLA-specific antibodies, donor specific antibodies, transplant in older age, machine learning, predictive models, rejection
- Medical subject headings
- Frailty, Disease, Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cf-DNADiagnostic test
Also called donor derived cell-free DNA (dd-cf DNA)
In addition to the standard of care tests, participants will have an additional blood sample (dd-cf DNA). A cohort study patients who have undergone high immunological risk kidney transplant at our centre defined as a re-transplant, where the cRF is >20% or where there is a level 4 HLA-mismatch. We will take a single plasma sample for dd-cfDNA testing at 6-12 months post-transplant and pair this with an assessment of renal function (creatinine, eGFR), MSU, BK and CMV PCR, single antigen bead (SAB) monitoring of HLA-specific antibodies and allograft USS.
Immunological Events following renal transplant in older ageDiagnostic test
Also called Longitudinal DSA monitoring
Determine the overall frequency of immunological events and de novo HLA specific antibody formation in the <60 and >60 age population. Standard of care test taken at the different time intervals for routine storage. We will use those samples for HLA testing (either screening alone or screening and single antigen bead testing if screening yields a positive result).
Determining Predictive Models for Post-transplant HLA-specific Antibody FormationOther
Also called Machine learning algorithms
A machine learning model will be developed in Python using a range of pre- and post-transplant variables to determine a predictive model for de novo HLA-specific antibody following renal transplant.
| Study group | Role | What they receive |
|---|---|---|
| cf-DNA arm | Participants will be recruited on the basis of having received a renal transplant within the last 6-12 months which has been deemed high risk. They will be identified from a database currently held within the renal transplant unit by members of the direct care team. They will be approached at a routine outpatient appointment for inclusion into the study and testing can be performed at their time of routine post-transplant testing where they will undergo blood (dd-cf DNA NGS assay), standard of care tests: blood count, renal profile, donor specific antibodies (DSA) sample, BK virus PCR, CMV PCR, urine testing and an ultrasound of the graft. Receives: Diagnostic Test: cf-DNA | |
| Immunological Events following renal transplant in older age | The renal transplant population will be divided on the basis of age into two cohort: ≥60 and <60. All renal transplant patients are regularly followed up in the outpatient clinic where blood and urine tests are collected, and clinical evaluations are performed. It is not foreseen that this study will necessitate any additional hospital visits or testing above and beyond the usual standard of care. Serum samples are taken at the time intervals indicated for routine storage and we will simply use those samples for HLA testing (either screening alone or screening and single antigen bead testing if screening yields a positive result). Receives: Diagnostic Test: Immunological Events following renal transplant in older age | |
| Determining Predictive Models for Post-transplant HLA-specific Antibody Formation | A subset of the cohort of recruits to the immunological factors in older age study will be used to determine machine learning algorithms of predictive factors for the development of de novo donor specific antibody. Only patients who were unsensitised prior to the kidney transplant will be included into the study because prior sensitisation makes determining de novo specificities much harder. The follow up period will be set at 1 year to synchronise with the older age study. Receives: Other: Determining Predictive Models for Post-transplant HLA-specific Antibody Formation |
What is being measured
The primary outcome is the main question the study is designed to answer.
dd-cf DNA
Occurrence of a positive cell free DNA test in high-risk post-transplant patients at 6-12 months
Measured: 6-12 months post-transplant
Immunological events in older age
Frequency of the development of immunological events in the over 60s versus <60 cohorts
Measured: through study completion, an average of 1 year
Longitudinal DSA monitoring
Frequency of development of de novo HLA specific antibody in the 1st year following transplantation in patients previously unsensitised.
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Occurrence of UTIs, viral reactivation and structural transplant abnormalities in high-risk post-transplant patients at 6-12 months
as above
Measured: 6-12 months
Association of cell free DNA result and any identified pathology (DSA, UTI, viral infection)
as above
Measured: through study completion, an average of 1 year
Comparison of graft and patient survival to 12 months in the over 60s and <60
as above
Measured: through study completion, an average of 1 year
Comparison of renal function, viral reactivation, readmission and reoperation rates between the 2 age groups (over 60s and <60)
as above
Measured: through study completion, an average of 1 year
Comparison of post-transplant complications (utilising the Clavien-Dindo classification of surgical complications) between patients developing de novo HLA specific antibody and those who do not, using machine learning models
as above
Measured: through study completion, an average of 1 year
Comparison of post-transplant graft and patient survival between patients developing de novo HLA specific antibody and those who do not, using machine learning models
as above
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start13 Oct 2023
- Primary completion13 Oct 2025 (estimated)
- Study completion13 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies 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
- Other
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Kidney Research United Kingdom
- Responsible party
- Sponsor
- Investigators
- Petra M Goldsmith, MBBChir PhD FRCS, Study director, Liverpool University Hospitals NHS Foundation TrustGeorge E Nita, MBChB MSc MRCSEd, Principal investigator, Liverpool University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025240
- Sponsor's protocol ID
- LHS0037
- Acronym
- HLA-AB
- Status last verified
- Apr 2024
- First submitted
- 22 Aug 2023
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT06025240
- Acronym / sponsor ID
- HLA-AB / LHS0037
- Conditions
- Kidney Transplant, Renal Transplant Failure, Kidney Transplant Rejection, Frailty, Kidney Transplant; Complications, Transplant Dysfunction
- Keywords
- kidney transplant, novel biomarkers, post-transplant antibodies, HLA-specific antibodies, donor specific antibodies, transplant in older age, machine learning, predictive models
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Collaborators
- Kidney Research United Kingdom
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 13 Oct 2025 (estimated)
- Study completion
- 13 Oct 2026 (estimated)
- First posted
- 6 Sep 2023 (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 purpose of this study is to assess a new test to detect antibodies which may form following kidney transplant. These antibodies can be difficult to detect as they do not cause any symptoms but can lead to kidney damage. A new blood test will be performed alongside existing antibody tests to see how well the test functions in comparison and to see how well it is able to distinguish between inflammation caused by antibodies and other sorts of inflammation such as a urinary tract infection. The investigators also want to determine whether it is predictable whom will develop antibodies after a transplant and use these results to change the current way patients are monitored for antibodies after receiving a transplant. In addition to this, the investigators want to establish if patients over 60 years of age are relatively protected against immunological events such as rejection compared to patients who are under 60 years of age. The results could potentially lead to using a different immunosuppression regime based on which population age group patients belong to and lowering the risks associated with these drugs.
Detailed description
Donor-derived cell-free DNA (dd-cfDNA)
Post-transplant monitoring for acute rejection in most centres, focuses on identification of a deterioration in graft function which may be totally asymptomatic. The current best practice to investigate a suspected rejection are renal graft biopsy with appropriate staining for complement component C4d and a serum single antigen bead (SAB) testing. This reactive approach to assessing and monitoring rejection, mainly driven by serial assessments of renal function to determine response to treatment, avoids the need for multiple invasive diagnostic tests such as biopsies, but it poses the risk of missing the early detection and treatment of rejection prior to an objective decline in function. A "creeping creatinine", where there are small but sustained increases in creatinine at sequential visits is relatively common and by the time a deterioration consistent with rejection is observed there can already have been significant tissue damage.
Donor-derived cell-free DNA (dd-cfDNA) has been described as a useful biomarker for graft injury secondary to rejection which can be evident in blood weeks to months prior to histological evidence of graft injury. dd-cfDNA levels are high in the immediate post-operative phase, although there is a sharp drop off to low baseline levels after a few days to two weeks making it a useful biomarker in all but the earliest rejection episode. Levels are much higher in antibody mediated rejection (ABMR) when compared to cellular rejection offering improvements in sensitivity when considering ABMR alone (85%) versus rejection of all aetiology (59%). The investigators believe it is important to correlate the findings of the dd-cfDNA sample with the other tests described, so that observations about the percentage dd-cfDNA found in different pathologies and the overall frequency of positive results can be made.
Immunological Factors in Older Age Renal Transplant and Longitudinal Donor Specific Antibodies (DSA) study
Older patients who undergo kidney transplant (KT) have better survival than those who remain on the waiting list. Nevertheless, outcomes are inferior to younger recipients and KT is often felt to be a predominantly quality of life intervention for older patients. Frailty may have a beneficial influence on the risk of post-transplant adverse immunological events and rejection episodes. If transplanted with good quality organs (all barring elderly deceased after circulatory death - DCD grafts), older kidney transplant recipients will have fewer rejection episodes than younger counterparts. The investigators conducted a retrospective cohort study of the outcomes for older age transplant recipients (>60) locally, to compare results before and after the change in allocation system which coincides with the COVID-19 pandemic. In this study, the investigators observed less favourable HLA-mismatching, a higher rate of re-intervention (operative or interventional radiology), higher rates of tertiary centre readmissions and higher 1-year mortality rates.
The previous post-transplant HLA-specific antibody work examined only the first positive sample post-transplant independent of pre-transplant sensitisation status. The investigators, thus, propose prospectively recruiting patients, irrespective of age, undergoing transplant to determine the overall frequency of immunological events and de novo HLA specific antibody formation. Given the importance of early detection and intervention of antibody mediated processes and optimising treatment protocols for frail patients, the investigators aim to expand the research interest in post-transplant antibody monitoring. The investigators, thus, propose prospectively recruiting patients, irrespective of age, undergoing transplant to determine the overall frequency of immunological events and de novo HLA specific antibody formation. Data on clinical outcomes will be collected and the investigators would look to compare the <60s with those 60 or older patients undergoing kidney transplant.
Determining Predictive Models for Post-transplant HLA-specific Antibody Formation
As an adjunct to the proposed study looking at the influence of age on immunological events, the investigators aim to examine the cohort as a whole to determine the differential clinical outcomes for patients with and without de novo HLA-specific antibody over time. An important part of this arm of the study will be to determine predictive models using machine learning methodology to determine those most at risk for the development of de-novo HLA specific antibody post-transplant.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cf-DNA arm | – | Diagnostic Test: cf-DNAParticipants will be recruited on the basis of having received a renal transplant within the last 6-12 months which has been deemed high risk. They will be identified from a database currently held within the renal transplant unit by members of the direct care team. They will be approached at a routine outpatient appointment for inclusion into the study and testing can be performed at their time of routine post-transplant testing where they will undergo blood (dd-cf DNA NGS assay), standard of care tests: blood count, renal profile, donor specific antibodies (DSA) sample, BK virus PCR, CMV PCR, urine testing and an ultrasound of the graft. |
| Immunological Events following renal transplant in older age | – | Diagnostic Test: Immunological Events following renal transplant in older ageThe renal transplant population will be divided on the basis of age into two cohort: ≥60 and <60. All renal transplant patients are regularly followed up in the outpatient clinic where blood and urine tests are collected, and clinical evaluations are performed. It is not foreseen that this study will necessitate any additional hospital visits or testing above and beyond the usual standard of care. Serum samples are taken at the time intervals indicated for routine storage and we will simply use those samples for HLA testing (either screening alone or screening and single antigen bead testing if screening yields a positive result). |
| Determining Predictive Models for Post-transplant HLA-specific Antibody Formation | – | Other: Determining Predictive Models for Post-transplant HLA-specific Antibody FormationA subset of the cohort of recruits to the immunological factors in older age study will be used to determine machine learning algorithms of predictive factors for the development of de novo donor specific antibody. Only patients who were unsensitised prior to the kidney transplant will be included into the study because prior sensitisation makes determining de novo specificities much harder. The follow up period will be set at 1 year to synchronise with the older age study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. cf-DNA arm: Patients who have undergone a "high risk" renal transplant in our unit within the last 6-12 months will be retrospectively recruited to the study. 2. Older Age Immunological Events: Post-transplant patients prospectively recruited, irrespective of age, undergoing transplant to determine the overall frequency of immunological events and de novo HLA specific antibody formation. We will collect data on clinical outcomes and would look to compare the <60s with those 60 or older looking for a difference in immunological events beteween the 2 groups. 3. Predictive models: A subset of the cohort of recruits to the immunological factors in older age study will be used to determine machine learning algorithms of predictive factors for the development of de novo donor specific antibody.
Key inclusion criteria (10 listed)
- cf-DNA arm:
- Older Age Immunological Events:
- Predictive models:
Key exclusion criteria (11 listed)
- cf-DNA arm:
- Older Age Immunological Events:
- Predictive models:
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 |
|---|---|---|
| cf-DNAAlso: donor derived cell-free DNA (dd-cf DNA)In addition to the standard of care tests, participants will have an additional blood sample (dd-cf DNA). A cohort study patients who have undergone high immunological risk kidney transplant at our centre defined as a re-transplant, where the cRF is >20% or where there is a level 4 HLA-mismatch. We will take a single plasma sample for dd-cfDNA testing at 6-12 months post-transplant and pair this with an assessment of renal function (creatinine, eGFR), MSU, BK and CMV PCR, single antigen bead (SAB) monitoring of HLA-specific antibodies and allograft USS. | Diagnostic test | cf-DNA arm |
| Immunological Events following renal transplant in older ageAlso: Longitudinal DSA monitoringDetermine the overall frequency of immunological events and de novo HLA specific antibody formation in the <60 and >60 age population. Standard of care test taken at the different time intervals for routine storage. We will use those samples for HLA testing (either screening alone or screening and single antigen bead testing if screening yields a positive result). | Diagnostic test | Immunological Events following renal transplant in older age |
| Determining Predictive Models for Post-transplant HLA-specific Antibody FormationAlso: Machine learning algorithmsA machine learning model will be developed in Python using a range of pre- and post-transplant variables to determine a predictive model for de novo HLA-specific antibody following renal transplant. | Other | Determining Predictive Models for Post-transplant HLA-specific Antibody Formation |
Primary outcome
dd-cf DNA
Time frame: 6-12 months post-transplant
Occurrence of a positive cell free DNA test in high-risk post-transplant patients at 6-12 months
Immunological events in older age
Time frame: through study completion, an average of 1 year
Frequency of the development of immunological events in the over 60s versus <60 cohorts
Longitudinal DSA monitoring
Time frame: through study completion, an average of 1 year
Frequency of development of de novo HLA specific antibody in the 1st year following transplantation in patients previously unsensitised.
6 secondary outcomes
Occurrence of UTIs, viral reactivation and structural transplant abnormalities in high-risk post-transplant patients at 6-12 months
Time frame: 6-12 months
Association of cell free DNA result and any identified pathology (DSA, UTI, viral infection)
Time frame: through study completion, an average of 1 year
Comparison of graft and patient survival to 12 months in the over 60s and <60
Time frame: through study completion, an average of 1 year
Comparison of renal function, viral reactivation, readmission and reoperation rates between the 2 age groups (over 60s and <60)
Time frame: through study completion, an average of 1 year
Comparison of post-transplant complications (utilising the Clavien-Dindo classification of surgical complications) between patients developing de novo HLA specific antibody and those who do not, using machine learning models
Time frame: through study completion, an average of 1 year
Comparison of post-transplant graft and patient survival between patients developing de novo HLA specific antibody and those who do not, using machine learning models
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Petra M Goldsmith, MBBChir PhD FRCS study director
Liverpool University Hospitals NHS Foundation Trust
George E Nita, MBChB MSc MRCSEd principal investigator
Liverpool University Hospitals NHS Foundation Trust
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 Kidney Transplant and Renal Transplant Failure, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 30 Aug 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George E Nita, MBChB MSc MRCSEd (01517062000, george.nita@liverpoolft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dd-cf DNA (time frame: 6-12 months post-transplant). 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 30 Aug 2024.