Identification and Treatment of Renal Stenosis in Transplanted Kidneys

Recruiting

• Conditions: Renal Artery Stenosis

• Registration Number: NCT06822205
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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.

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 Timeline

• Study Start: 2023-07-07
• Status Verified: 2024-11
• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of stenosis	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	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.

Trial Locations

Locations (1)

IRCCS AOU di Bologna Policlinico di Sant'Orsola; 🇮🇹 Bologna, Italy