Identification and Treatment of Renal Stenosis in Transplanted Kidneys (TRAS)

February 6, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Renal artery stenosis is a complication that may follow kidney transplantation1-5. Renal artery stenosis greater than 50% of the lumen of the artery, associated with clinical symptoms or laboratory worsening of renal function, may lead to transplant failure, however, the indications for treatment and the modalities of treatment remain, to date, a debated topic in the literature. The guidelines of the European Society of Urology recommend endovascular treatment as the first-line treatment by means of angioplasty and/or stent placement6. A recent review of the literature7 examined the results of 56 studies: the results fully support endovascular treatment of the disease which appears to be effective and with a low rate of complications.

Study Overview

Status

Recruiting

Conditions

Renal Artery Stenosis

Detailed Description

The primary objectives of the study are to evaluate the efficacy (in terms of technical success and graft salvage) and safety (in terms of complications) of endovascular treatment using stenting in patients with renal artery stenosis following kidney transplantation.

Patients undergoing endovascular treatment of renal stenosis following kidney transplantation at the Vascular Surgery Unit from January 2020 to April 2023 (retrospective phase) and from May 2023 up to 2 years from the start of the study.

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Mauro Gargiulo, MD
Phone Number: 0512143288
Email: mauro.gargiulo2@unibo.it

Study Locations

Italy
- - Bologna, Italy, 40138
    - Recruiting
    - IRCCS AOU di Bologna Policlinico di Sant'Orsola
    - Contact:
      
      Mauro Prof Gargiulo, MD
      
      Phone Number: 0512143288
      
      Email: mauro.gargiulo2@unibo.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Description

Inclusion Criteria:

Age greater than or equal to 18 years
Indication of renal transplant and diagnosis of renal artery stenosis of the transplant
Obtaining informed consent

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of stenosis Time Frame: From the first patient enrolled up to the 30th patient, an average of 3 years	Efficacy is assessed by a reduction in stenosis of at least 50% based on the TC image	From the first patient enrolled up to the 30th patient, an average of 3 years
Renal function improvement Time Frame: From the first patient enrolled, up to the 30th patient. An average of 3 years	It is assessed through the improvement in eGFR and Creatinine values, compared to baseline.	From the first patient enrolled, up to the 30th patient. An average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Principal Investigator: Mauro Gargiulo, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)