Aortoiliac Stenosis in Kidney Transplantation

NCT06020534 | Completed Results

• 1 other identifier: KT TASC
• Study Type: observational
• Target: 655
• Locations: 1 country
• Sites: 1

Brief Summary

The impact of aortoiliac stenosis on kidney transplant patients remains unclear. This study aims to investigate the safety and efficacy of kidney transplantation in patients with aortoiliac stenosis.

Conditions

Aorto-Iliac Arterial Stenosis; Peripheral Arterial Disease; Kidney Transplant Failure

Keywords

aortoiliac arterial stenosis; peripheral arterial disease; kidney transplantation; outcomes

Outcome Measures

Primary Outcomes (1)

• Patient Survival

  Patient survival was calculated based on all-cause death from the date of kidney transplantation till the end of follow-up (January, 2023), assessed up to 10 years.

  From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.

Secondary Outcomes (2)

• Death-censored Graft Survival

  From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.

• Graft Function

  From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.

Study Arms (3)

No-stenosis group

Patients who had no pre-existing aortoiliac stenosis before kidney transplantation.

TASC A/B stenosis

Patients who had TASC A or B aortoiliac stenosis before kidney transplantation.

TASC C/D stenosis

Patients who had TASC C or D aortoiliac stenosis before kidney transplantation.

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 who underwent kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020.

You may qualify if:

• Patients who underwent kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020

You may not qualify if:

• Patients who were under 18 years at transplantation
• Patients who underwent combined organ transplantation
• Patients who had no follow-up

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Yitian Fang

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Related Publications (1)

• Fang Y, Hamm JJM, den Hartog FPJ, Kimenai HJAN, de Bruin RWF, Minnee RC. Safety and efficacy of kidney transplantation in patients with aortoiliac stenosis: a retrospective cohort study. Int J Surg. 2024 Feb 1;110(2):992-999. doi: 10.1097/JS9.0000000000000926.

  PMID: 38016127 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Limitations and Caveats

Firstly, there is a guarantee for selection bias in patients with the most severe aortoiliac stenosis, as these patients might be rejected for kidney transplantation and would not be included in the study. Secondly, the study's single-center design could introduce institutional-specific practices that may not be universally applicable. Lastly, details of stenosis proximal or distal to the transplanted kidney were unknown.

Results Point of Contact

• Title: Drs. Yitian Fang
• Organization: Erasmus Medical Center

y.fang.1@erasmusmc.nl

+31 645680154

Study Officials

• Yitian Fang, MD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 31, 2023
• Study Start: January 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: June 30, 2023
• Last Updated: January 7, 2025
• Results First Posted: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)