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NCT Number: NCT06020534

Aortoiliac Stenosis in Kidney Transplantation

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.

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Key information

Conditions

Aorto-Iliac Arterial Stenosis Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Kidney Transplant Failure Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yitian Fang

Rotterdam, South Holland, 3015 GD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Patient Survival

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

    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.

Secondary outcomes

  1. Death-censored Graft Survival

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

    Death-censored graft survival was calculated based on death-censored graft failure, from the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.

  2. Graft Function

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

    Estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at every post transplant year up to 10 years.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

Safety and Efficacy of Kidney Transplantation in Patients With Aortoiliac Stenosis

Acronym: TASC

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2023
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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