Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05046496 |
Other study ID # |
20HH6286 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 28, 2021 |
Est. completion date |
August 2025 |
Study information
Verified date |
September 2023 |
Source |
Imperial College Healthcare NHS Trust |
Contact |
Paul Martin |
Phone |
02033136641 |
Email |
paul.martin9[@]nhs.net |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 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.
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.