Identification and Treatment of Renal Stenosis in Transplanted Kidneys

NCT06822205 | Recruiting

• 1 other identifier: TRAS
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Artery Stenosis

Outcome Measures

Primary Outcomes (2)

• Reduction of stenosis

  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

  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

Eligibility Criteria

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

Study Population

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.

You may qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS AOU di Bologna Policlinico di Sant'Orsola

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Renal Artery Obstruction

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mauro Gargiulo, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauro Gargiulo, MD

CONTACT

0512143288; mauro.gargiulo2@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: February 12, 2025
• Study Start: July 7, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 12, 2025

Record last verified: 2024-11

Locations

IT (1)