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TASC: Aortoiliac Stenosis in Kidney Transplantation

Sponsor
Erasmus Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT06020534
Collaborator
(none)
655
Enrollment
1
Location
17.9
Actual Duration (Months)
36.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Kidney transplantation is the optimal treatment for end-stage renal disease (ESRD). Unfortunately, not all ESRD patients are eligible for kidney transplantation. Aortoiliac stenosis, an increasingly common type of peripheral arterial disease in ESRD patients, is considered as relative contra-indication for kidney transplantation. There are several reasons for concern, such as the complexity of the vascular anastomosis and inferior life expectancy. Consequently, it is still debated whether patients with aortoiliac stenosis would benefit from kidney transplantation.

    This study aimed to supplement current literature on the safety and efficacy of kidney transplantation in patients with aortoiliac stenosis. To achieve this, all patients undergoing kidney transplantation in Erasmus Medical Center between January 2010 and December 2020 were enrolled, and propensity score matching was used to minimize confounding factors. Additionally, long-term graft function was investigated to evaluate the impact of stenosis on graft function.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    655 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Safety and Efficacy of Kidney Transplantation in Patients With Aortoiliac Stenosis
    Actual Study Start Date :
    Jan 1, 2022
    Actual Primary Completion Date :
    Jan 31, 2023
    Actual Study Completion Date :
    Jun 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. patient survival [From the date of kidney transplantation till death or January 2023.]

      All-cause death after kidney transplantation till the end of follow-up.

    Secondary Outcome Measures

    1. death-censored graft survival [From the date of kidney transplantation till death or January 2023.]

      Death-censored graft survival was defined as the time from transplant to graft failure, with censoring for death with a functioning graft.

    2. Graft function [From the date of kidney transplantation till death or January 2023.]

      Estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who underwent kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020
    Exclusion Criteria:

    • Patients who were under 18 years at transplantation

    • Patients who underwent combined organ transplantation

    • Patients who had no follow-up

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yitian Fang Rotterdam Zuid Holland Netherlands 3015 GD

    Sponsors and Collaborators

    • Erasmus Medical Center

    Investigators

    • Principal Investigator: Yitian Fang, MD, Erasmus Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yitian Fang, MD, Principal Investigator, Erasmus Medical Center
    ClinicalTrials.gov Identifier:
    NCT06020534
    Other Study ID Numbers:
    • KT TASC
    First Posted:
    Aug 31, 2023
    Last Update Posted:
    Aug 31, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yitian Fang, MD, Principal Investigator, Erasmus Medical Center
    aortoiliac arterial stenosis
    peripheral arterial disease
    kidney transplantation
    outcomes
    Additional relevant MeSH terms:
    Peripheral Arterial Disease
    Peripheral Vascular Diseases
    Constriction, Pathologic

    Study Results

    No Results Posted as of Aug 31, 2023