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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Kidney Transplant Failure
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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.