Transplant Renal Artery Stenosis: Observation Versus Stenting

NCT05046496 | Unknown

• 1 other identifier: 20HH6286
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Transplant Renal Artery Stenosis

Keywords

Kidney transplant; Transplant renal artery stenosis

Outcome Measures

Primary Outcomes (1)

• Change in eGFR between both arms

  measure of kidney transplant function

  1 year

Secondary Outcomes (9)

• Change in estimated glomerular filtration rate (eGFR)

  at baseline, then 1, 3, 6 and 12-months following diagnosis

• Change in mean arterial blood pressure (BP), systolic BP and diastolic BP

  at baseline, then 1, 3, 6 and 12-months following diagnosis

• Average number of anti-hypertensive medications

  at baseline, then 1, 3, 6 and 12-months following diagnosis

• Urinary protein : creatinine ratio (UPCR) measurement

  at baseline, then 1, 3, 6 and 12-months following diagnosis

• Donor-specific antibody (DSA) free survival

  1 year

Other Outcomes (1)

• Adverse event reporting

  1 year

Study Arms (2)

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

Diagnostic Test: Intra-arterial digital subtraction angiography

Interventions

Intra-arterial digital subtraction angiography DIAGNOSTIC_TEST

Invasive intra-arterial angiography, with intra-arterial stent placement if a stenosis is confirmed

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1. Renal transplant recipient with a diagnosis of TRAS by radiological imaging, and an MDT decision to proceed with diagnostic IADSA.
• \. Aged 18 years and over 3. Able to give informed consent

You may not qualify if:

• \- 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).
• \. 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.

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, England, W12 0HS, United Kingdom

RECRUITING

Study Officials

• Michelle Willicombe

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Martin

CONTACT

02033136641; paul.martin9@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 16, 2021
• Study Start: August 28, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)