An interventional study of Intra-arterial digital subtraction angiography in Transplant Renal Artery Stenosis, sponsored by Imperial College Healthcare NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by Imperial College Healthcare NHS Trust · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Patients recruited to this arm will undergo no intervention.
Patients recruited to this arm will undergo intra-arterial digital subtraction angiography, with or without intra-arterial stent placement
Diagnostic Test: Intra-arterial digital subtraction angiography
Invasive intra-arterial angiography, with intra-arterial stent placement if a stenosis is confirmed
Change in eGFR between both arms
measure of kidney transplant function
Time frame: 1 year
Change in estimated glomerular filtration rate (eGFR)
measure of kidney transplant function
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
Measure of cardiovascular health
Time frame: at baseline, then 1, 3, 6 and 12-months following diagnosis
Average number of anti-hypertensive medications
measure of cardiovascular health
Time frame: at baseline, then 1, 3, 6 and 12-months following diagnosis
Urinary protein : creatinine ratio (UPCR) measurement
measure of proteinuria
Time frame: 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
Time frame: 1 year
Rejection free survival
measure of time free from histologically proven kidney transplant rejection
Time frame: 1 year
Renal allograft failure
Measure of time free from kidney transplant failure
Time frame: 1 year
Patient survival
measure of patient survival
Time frame: 1 year
Requirement for intervention (primary angiogram in observational group, secondary angiogram in interventional group)
Quantification of patients that require intervention
Time frame: 1 year
Adverse event reporting
reporting of any adverse events that afflict study participants
Time frame: 1 year
Plan to share: No
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Imperial College Healthcare NHS Trust