Identification and Treatment of Renal Stenosis in Transplanted Kidneys

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.

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Key information

Conditions

Renal Artery Stenosis Arterial Occlusive Diseases Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Artery Obstruction Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS AOU di Bologna Policlinico di Sant'Orsola

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Mauro Prof Gargiulo, MD

CONTACT

[email protected]

0512143288

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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
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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mauro Gargiulo, MD

CONTACT

[email protected]

0512143288

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: TRAS

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Feb 12, 2025
Registry last updated: Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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