Transplant Renal Artery StenosisTRASOSNCT05046496
Transplant Renal Artery Stenosis: Observation Versus Stenting
A study testing Intra-arterial digital subtraction angiography in people with Transplant Renal Artery Stenosis, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
Transplant renal artery stenosis (TRAS) is abnormal narrowing of the main blood vessel to the kidney transplant and has historically been considered a surgical complication. In heart transplantation, it has long been recognised that rejection can cause narrowing of the heart's blood vessels, and that this complication… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant Renal Artery Stenosis
- What is being tested?
- Intra-arterial digital subtraction angiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Aug 2021to Aug 2025
- Phase
- Interventional
- 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
Who may be able to join
- 1. Renal transplant recipient with a diagnosis of TRAS by radiological imaging, and an MDT decision to proceed with diagnostic IADSA.
- 2. Aged 18 years and over 3. Able to give informed consent
Who cannot join
- 1. Estimated GFR <10mls/min/1.73m2 or dialysis dependence 2. Contraindication to angiography (e.g. allergy to radiological contrast) 3. Patients with clinical features of severe TRAS (eg. resistant hypertension, pulmonary oedema and/or rapidly deteriorating function).
- 4. Any condition or co-morbidity which in the investigator's opinion would make the patient ineligible for the trial or unlikely to adhere to trial procedures.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, England, W12 0HS
Michelle Willicombe, MBBS MD, 02033136641, michelle.willicombe@nhs.net
Paul Martin, MBBS MSc, paul.martin9@nhs.net
About this study
Official title: Transplant Renal Artery Stenosis: Observation Versus Stenting - a Feasibility Study
Transplant renal artery stenosis (TRAS) is abnormal narrowing of the main blood vessel to the kidney transplant and has historically been considered a surgical complication. In heart transplantation, it has long been recognised that rejection can cause narrowing of the heart's blood vessels, and that this complication is the leading cause of heart transplant failure. It is reasonable to assume that this process may also occur in kidney transplantation, which could contribute to premature transplant failure. However, in kidney transplantation it is also likely that other factors, such as surgical factors, traditional cardiovascular risk factors and immunological factors, contribute to the development of TRAS. Given that the disease processes that cause TRAS are not fully understood, at present there is no consensus among kidney doctors on the best means of treating patients diagnosed with TRAS. The aim of the proposed study is to investigate the involvement of these different processes in the development of TRAS, and investigate the optimal way to diagnose and manage TRAS.
At present, there is no standard recommendation for how to treat patients with TRAS. This is partly due to the fact that patients with TRAS may have a broad array of symptoms: Some may have no symptoms, other may have problems with high blood pressure or fluid accumulation, and others may have severe transplant dysfunction. In most transplant centres, patient TRAS and severe symptoms will undergo IADSA and a stent will be placed to open the narrowing. However, it is not clear how best to manage patients with TRAS who have mild to moderate symptoms. We propose to recruit 36 such patients to a clinical study and split them into two groups: One group to undergo IADSA with possible stent placement, and one group to be closely observed. We will then compare transplant function, and other outcomes, after one year between the two groups.
Read the detailed description
Transplant renal artery stenosis (TRAS) is abnormal narrowing of the main blood vessel to the kidney transplant and has historically been considered a surgical complication. In heart transplantation, it has long been recognised that rejection can cause narrowing of the heart's blood vessels, and that this complication is the leading cause of heart transplant failure. It is reasonable to assume that this process may also occur in kidney transplantation, which could contribute to premature transplant failure. However, in kidney transplantation it is also likely that other factors, such as surgical factors, traditional cardiovascular risk factors and immunological factors, contribute to the development of TRAS. Given that the disease processes that cause TRAS are not fully understood, at present there is no consensus among kidney doctors on the best means of treating patients diagnosed with TRAS. The aim of the proposed study is to investigate the involvement of these different processes in the development of TRAS, and investigate the optimal way to diagnose and manage TRAS.
At present, there is no standard recommendation for how to treat patients with TRAS. This is partly due to the fact that patients with TRAS may have a broad array of symptoms: Some may have no symptoms, other may have problems with high blood pressure or fluid accumulation, and others may have severe transplant dysfunction. In most transplant centres, patient TRAS and severe symptoms will undergo IADSA and a stent will be placed to open the narrowing. However, it is not clear how best to manage patients with TRAS who have mild to moderate symptoms. We propose to recruit 36 such patients to a clinical study and split them into two groups: One group to undergo IADSA with possible stent placement, and one group to be closely observed. We will then compare transplant function, and other outcomes, after one year between the two groups.
- Conditions
- Transplant Renal Artery Stenosis
- Being tested
- Intra-arterial digital subtraction angiography
- Keywords
- Kidney transplant, Transplant renal artery stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-arterial digital subtraction angiographyDiagnostic test
Invasive intra-arterial angiography, with intra-arterial stent placement if a stenosis is confirmed
| Study group | Role | What they receive |
|---|---|---|
| Observational arm | No intervention | Patients recruited to this arm will undergo no intervention. |
| Interventional arm | Active comparator | Patients recruited to this arm will undergo intra-arterial digital subtraction angiography, with or without intra-arterial stent placement Receives: Diagnostic Test: Intra-arterial digital subtraction angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eGFR between both arms
measure of kidney transplant function
Measured: 1 year
Secondary outcomes (9)
Change in estimated glomerular filtration rate (eGFR)
measure of kidney transplant function
Measured: at baseline, then 1, 3, 6 and 12-months following diagnosis
Change in mean arterial blood pressure (BP), systolic BP and diastolic BP
Measure of cardiovascular health
Measured: at baseline, then 1, 3, 6 and 12-months following diagnosis
Average number of anti-hypertensive medications
measure of cardiovascular health
Measured: at baseline, then 1, 3, 6 and 12-months following diagnosis
Urinary protein : creatinine ratio (UPCR) measurement
measure of proteinuria
Measured: at baseline, then 1, 3, 6 and 12-months following diagnosis
Donor-specific antibody (DSA) free survival
measure of time free from presence of donor-specific antibody in participant's serum
Measured: 1 year
Rejection free survival
measure of time free from histologically proven kidney transplant rejection
Measured: 1 year
Renal allograft failure
Measure of time free from kidney transplant failure
Measured: 1 year
Patient survival
measure of patient survival
Measured: 1 year
Requirement for intervention (primary angiogram in observational group, secondary angiogram in interventional group)
Quantification of patients that require intervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start28 Aug 2021
- Primary completionAug 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant Renal Artery StenosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Willicombe, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046496
- Sponsor's protocol ID
- 20HH6286
- Acronym
- TRASOS
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2021
- Last updated
- 29 Sep 2023
- 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 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplant Renal Artery Stenosis: Observation Versus Stenting - a Feasibility Study
- ClinicalTrials.gov ID
- NCT05046496
- Acronym / sponsor ID
- TRASOS / 20HH6286
- Conditions
- Transplant Renal Artery Stenosis
- Keywords
- Kidney transplant, Transplant renal artery stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 28 Aug 2021 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 16 Sep 2021 (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.
Transplant renal artery stenosis (TRAS) is abnormal narrowing of the main blood vessel to the kidney transplant and has historically been considered a surgical complication. In heart transplantation, it has long been recognised that rejection can cause narrowing of the heart's blood vessels, and that this complication is the leading cause of heart transplant failure. It is reasonable to assume that this process may also occur in kidney transplantation, which could contribute to premature transplant failure. However, in kidney transplantation it is also likely that other factors, such as surgical factors, traditional cardiovascular risk factors and immunological factors, contribute to the development of TRAS. Given that the disease processes that cause TRAS are not fully understood, at present there is no consensus among kidney doctors on the best means of treating patients diagnosed with TRAS. The aim of the proposed study is to investigate the involvement of these different processes in the development of TRAS, and investigate the optimal way to diagnose and manage TRAS.
At present, there is no standard recommendation for how to treat patients with TRAS. This is partly due to the fact that patients with TRAS may have a broad array of symptoms: Some may have no symptoms, other may have problems with high blood pressure or fluid accumulation, and others may have severe transplant dysfunction. In most transplant centres, patient TRAS and severe symptoms will undergo IADSA and a stent will be placed to open the narrowing. However, it is not clear how best to manage patients with TRAS who have mild to moderate symptoms. We propose to recruit 36 such patients to a clinical study and split them into two groups: One group to undergo IADSA with possible stent placement, and one group to be closely observed. We will then compare transplant function, and other outcomes, after one year between the two groups.
Detailed description
Transplant renal artery stenosis (TRAS) is abnormal narrowing of the main blood vessel to the kidney transplant and has historically been considered a surgical complication. In heart transplantation, it has long been recognised that rejection can cause narrowing of the heart's blood vessels, and that this complication is the leading cause of heart transplant failure. It is reasonable to assume that this process may also occur in kidney transplantation, which could contribute to premature transplant failure. However, in kidney transplantation it is also likely that other factors, such as surgical factors, traditional cardiovascular risk factors and immunological factors, contribute to the development of TRAS. Given that the disease processes that cause TRAS are not fully understood, at present there is no consensus among kidney doctors on the best means of treating patients diagnosed with TRAS. The aim of the proposed study is to investigate the involvement of these different processes in the development of TRAS, and investigate the optimal way to diagnose and manage TRAS.
At present, there is no standard recommendation for how to treat patients with TRAS. This is partly due to the fact that patients with TRAS may have a broad array of symptoms: Some may have no symptoms, other may have problems with high blood pressure or fluid accumulation, and others may have severe transplant dysfunction. In most transplant centres, patient TRAS and severe symptoms will undergo IADSA and a stent will be placed to open the narrowing. However, it is not clear how best to manage patients with TRAS who have mild to moderate symptoms. We propose to recruit 36 such patients to a clinical study and split them into two groups: One group to undergo IADSA with possible stent placement, and one group to be closely observed. We will then compare transplant function, and other outcomes, after one year between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational arm | No intervention | –Patients recruited to this arm will undergo no intervention. |
| Interventional arm | Active comparator | Diagnostic Test: Intra-arterial digital subtraction angiographyPatients recruited to this arm will undergo intra-arterial digital subtraction angiography, with or without intra-arterial stent placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Renal transplant recipient with a diagnosis of TRAS by radiological imaging, and an MDT decision to proceed with diagnostic IADSA.
- 2. Aged 18 years and over 3. Able to give informed consent
Key exclusion criteria (2 listed)
- 1. Estimated GFR <10mls/min/1.73m2 or dialysis dependence 2. Contraindication to angiography (e.g. allergy to radiological contrast) 3. Patients with clinical features of severe TRAS (eg. resistant hypertension, pulmonary oedema and/or rapidly deteriorating function).
- 4. Any condition or co-morbidity which in the investigator's opinion would make the patient ineligible for the trial or unlikely to adhere to trial procedures.
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 |
|---|---|---|
| Intra-arterial digital subtraction angiographyInvasive intra-arterial angiography, with intra-arterial stent placement if a stenosis is confirmed | Diagnostic test | Interventional arm |
Primary outcome
Change in eGFR between both arms
Time frame: 1 year
measure of kidney transplant function
9 secondary outcomes
Change in estimated glomerular filtration rate (eGFR)
Time frame: at baseline, then 1, 3, 6 and 12-months following diagnosis
Change in mean arterial blood pressure (BP), systolic BP and diastolic BP
Time frame: at baseline, then 1, 3, 6 and 12-months following diagnosis
Average number of anti-hypertensive medications
Time frame: at baseline, then 1, 3, 6 and 12-months following diagnosis
Urinary protein : creatinine ratio (UPCR) measurement
Time frame: at baseline, then 1, 3, 6 and 12-months following diagnosis
Donor-specific antibody (DSA) free survival
Time frame: 1 year
Rejection free survival
Time frame: 1 year
Renal allograft failure
Time frame: 1 year
Patient survival
Time frame: 1 year
Requirement for intervention (primary angiogram in observational group, secondary angiogram in interventional group)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Michelle Willicombe principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-arterial digital subtraction angiography in people with Transplant Renal Artery Stenosis, run by Imperial College Healthcare NHS 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 2 inclusion and 2 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 29 Sep 2023. 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 Paul Martin (02033136641, paul.martin9@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in eGFR between both arms (time frame: 1 year). 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 29 Sep 2023.