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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.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date August 2025
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Intervention

Diagnostic Test:
Intra-arterial digital subtraction angiography
Invasive intra-arterial angiography, with intra-arterial stent placement if a stenosis is confirmed

Locations

Country Name City State
United Kingdom Imperial College Healthcare NHS Trust London England

Sponsors (1)

Lead Sponsor Collaborator
Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Adverse event reporting reporting of any adverse events that afflict study participants 1 year
Primary Change in eGFR between both arms measure of kidney transplant function 1 year
Secondary Change in estimated glomerular filtration rate (eGFR) measure of kidney transplant function at baseline, then 1, 3, 6 and 12-months following diagnosis
Secondary Change in mean arterial blood pressure (BP), systolic BP and diastolic BP Measure of cardiovascular health at baseline, then 1, 3, 6 and 12-months following diagnosis
Secondary Average number of anti-hypertensive medications measure of cardiovascular health at baseline, then 1, 3, 6 and 12-months following diagnosis
Secondary Urinary protein : creatinine ratio (UPCR) measurement measure of proteinuria at baseline, then 1, 3, 6 and 12-months following diagnosis
Secondary Donor-specific antibody (DSA) free survival measure of time free from presence of donor-specific antibody in participant's serum 1 year
Secondary Rejection free survival measure of time free from histologically proven kidney transplant rejection 1 year
Secondary Renal allograft failure Measure of time free from kidney transplant failure 1 year
Secondary Patient survival measure of patient survival 1 year
Secondary Requirement for intervention (primary angiogram in observational group, secondary angiogram in interventional group) Quantification of patients that require intervention 1 year
See also
  Status Clinical Trial Phase
Completed NCT04225338 - Retrospective Study of Patients Undergoing Percutaneous Intervention of the Transplant Renal Artery Stenosis