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Transplant Renal Artery Stenosis: Observation Versus Stenting (TRASOS)

Primary Purpose

Transplant Renal Artery Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intra-arterial digital subtraction angiography
Sponsored by
Imperial College Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transplant Renal Artery Stenosis focused on measuring Kidney transplant, Transplant renal artery stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Imperial College Healthcare NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Observational arm

Interventional arm

Arm Description

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

Outcomes

Primary Outcome Measures

Change in eGFR between both arms
measure of kidney transplant function

Secondary Outcome Measures

Change in estimated glomerular filtration rate (eGFR)
measure of kidney transplant function
Change in mean arterial blood pressure (BP), systolic BP and diastolic BP
Measure of cardiovascular health
Average number of anti-hypertensive medications
measure of cardiovascular health
Urinary protein : creatinine ratio (UPCR) measurement
measure of proteinuria
Donor-specific antibody (DSA) free survival
measure of time free from presence of donor-specific antibody in participant's serum
Rejection free survival
measure of time free from histologically proven kidney transplant rejection
Renal allograft failure
Measure of time free from kidney transplant failure
Patient survival
measure of patient survival
Requirement for intervention (primary angiogram in observational group, secondary angiogram in interventional group)
Quantification of patients that require intervention

Full Information

First Posted
September 7, 2021
Last Updated
September 27, 2023
Sponsor
Imperial College Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05046496
Brief Title
Transplant Renal Artery Stenosis: Observation Versus Stenting
Acronym
TRASOS
Official Title
Transplant Renal Artery Stenosis: Observation Versus Stenting - a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College Healthcare NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transplant Renal Artery Stenosis
Keywords
Kidney transplant, Transplant renal artery stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Observational arm
Arm Type
No Intervention
Arm Description
Patients recruited to this arm will undergo no intervention.
Arm Title
Interventional arm
Arm Type
Active Comparator
Arm Description
Patients recruited to this arm will undergo intra-arterial digital subtraction angiography, with or without intra-arterial stent placement
Intervention Type
Diagnostic Test
Intervention Name(s)
Intra-arterial digital subtraction angiography
Intervention Description
Invasive intra-arterial angiography, with intra-arterial stent placement if a stenosis is confirmed
Primary Outcome Measure Information:
Title
Change in eGFR between both arms
Description
measure of kidney transplant function
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in estimated glomerular filtration rate (eGFR)
Description
measure of kidney transplant function
Time Frame
at baseline, then 1, 3, 6 and 12-months following diagnosis
Title
Change in mean arterial blood pressure (BP), systolic BP and diastolic BP
Description
Measure of cardiovascular health
Time Frame
at baseline, then 1, 3, 6 and 12-months following diagnosis
Title
Average number of anti-hypertensive medications
Description
measure of cardiovascular health
Time Frame
at baseline, then 1, 3, 6 and 12-months following diagnosis
Title
Urinary protein : creatinine ratio (UPCR) measurement
Description
measure of proteinuria
Time Frame
at baseline, then 1, 3, 6 and 12-months following diagnosis
Title
Donor-specific antibody (DSA) free survival
Description
measure of time free from presence of donor-specific antibody in participant's serum
Time Frame
1 year
Title
Rejection free survival
Description
measure of time free from histologically proven kidney transplant rejection
Time Frame
1 year
Title
Renal allograft failure
Description
Measure of time free from kidney transplant failure
Time Frame
1 year
Title
Patient survival
Description
measure of patient survival
Time Frame
1 year
Title
Requirement for intervention (primary angiogram in observational group, secondary angiogram in interventional group)
Description
Quantification of patients that require intervention
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Adverse event reporting
Description
reporting of any adverse events that afflict study participants
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Martin
Phone
02033136641
Email
paul.martin9@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Willicombe
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College Healthcare NHS Trust
City
London
State/Province
England
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Willicombe, MBBS MD
Phone
02033136641
Email
michelle.willicombe@nhs.net
First Name & Middle Initial & Last Name & Degree
Paul Martin, MBBS MSc
Email
paul.martin9@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
No

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Transplant Renal Artery Stenosis: Observation Versus Stenting

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