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NCT06020534 Clinical Trial

Aortoiliac Stenosis in Kidney Transplantation

Peripheral Arterial Disease Clinical Trial

— TASC  

Official title:
Safety and Efficacy of Kidney Transplantation in Patients With Aortoiliac Stenosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06020534
Other study ID # KT TASC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date June 30, 2023

Study information
Verified date August 2023
Source Erasmus Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 655
Est. completion date June 30, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Yitian Fang Rotterdam Zuid Holland

Sponsors (1)
Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary patient survival All-cause death after kidney transplantation till the end of follow-up. From the date of kidney transplantation till death or January 2023.
Secondary death-censored graft survival Death-censored graft survival was defined as the time from transplant to graft failure, with censoring for death with a functioning graft. From the date of kidney transplantation till death or January 2023.
Secondary Graft function Estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. From the date of kidney transplantation till death or January 2023.
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