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Aortoiliac Stenosis in Kidney Transplantation

Safety and Efficacy of Kidney Transplantation in Patients With Aortoiliac Stenosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06020534
Acronym
TASC
Enrollment
655
Registered
2023-08-31
Start date
2022-01-01
Completion date
2023-06-30
Last updated
2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

None listed

Sponsors

Erasmus Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Patient SurvivalFrom 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

MeasureTime frameDescription
Death-censored Graft SurvivalFrom 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.
Graft FunctionFrom 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.

Countries

Netherlands

Participant flow

Recruitment details

We initially identified all patients undergoing kidney transplantation in Erasmus Medical Center between January 2010 and December 2020. The exclusion criteria were age less than 18 years when transplanted, combined organ transplantation, or no follow-up data.

Pre-assignment details

We initially identified 2127 participants. Thirty-six patients were excluded according to the exclusion criteria. In the remaining participants, propensity score matching was performed in a nearest neighbor-matching approach with a maximum caliper of 0.1 in a 1 : 4 ratio to match the baseline characteristics of participants with and without aortoiliac stenosis. The matching parameters included age at transplant, dialysis mode, retransplant, donor type, comorbidities, and smoking status.

Participants by arm

ArmCount
No-stenosis Group
Patients who had no pre-existing aortoiliac stenosis before kidney transplantation.
524
TASC A/B Stenosis Group
Patients who had TASC A/B aortoiliac stenosis before kidney transplantation.
96
TASC C/D Stenosis Group
Patients who had TASC C/D aortoiliac stenosis before kidney transplantation.
35
Total655

Baseline characteristics

CharacteristicNo-stenosis GroupTASC C/D Stenosis GroupTASC A/B Stenosis GroupTotal
Age, Continuous66 years63 years66 years66 years
BMI28 kg/m228 kg/m227 kg/m228 kg/m2
Donor Type
DBD
87 Participants6 Participants15 Participants108 Participants
Donor Type
DCD
147 Participants14 Participants26 Participants187 Participants
Donor Type
Living Donor
290 Participants15 Participants55 Participants360 Participants
Duration of Dialysis22 months26 months22 months22 months
Race and Ethnicity Not Collected0 Participants
Retransplant87 Participants6 Participants15 Participants108 Participants
Sex: Female, Male
Female
169 Participants10 Participants34 Participants213 Participants
Sex: Female, Male
Male
355 Participants25 Participants62 Participants442 Participants
Smoking Status
Current Smoker
113 Participants7 Participants21 Participants141 Participants
Smoking Status
Former Smoker
261 Participants15 Participants50 Participants326 Participants
Smoking Status
Never Smoker
150 Participants13 Participants25 Participants188 Participants
Type of Dialysis
Combined Modality
38 Participants3 Participants8 Participants49 Participants
Type of Dialysis
Hemodialysis
297 Participants22 Participants52 Participants371 Participants
Type of Dialysis
Peritoneal Dialysis
69 Participants5 Participants12 Participants86 Participants
Type of Dialysis
Pre-emptive
120 Participants5 Participants24 Participants149 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
202 / 52448 / 9629 / 35
other
Total, other adverse events
0 / 5240 / 960 / 35
serious
Total, serious adverse events
0 / 5240 / 960 / 35

Outcome results

Primary

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.

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
No-stenosis GroupPatient Survival322 Participants
TASC A/B StenosisPatient Survival48 Participants
TASC C/D StenosisPatient Survival6 Participants
Secondary

Death-censored Graft Survival

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.

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
No-stenosis GroupDeath-censored Graft Survival443 Participants
TASC A/B StenosisDeath-censored Graft Survival80 Participants
TASC C/D StenosisDeath-censored Graft Survival26 Participants
Secondary

Graft Function

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.

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

Population: The discrepancy in the number of participants analyzed in one or more rows compared to the overall number of participants was due to attrition from graft failure or patient death over time.

ArmMeasureGroupValue (MEDIAN)
No-stenosis GroupGraft Function6 years posttransplant47 mL/min/1.73m2
No-stenosis GroupGraft Function2 years posttransplant46 mL/min/1.73m2
No-stenosis GroupGraft Function4 years posttransplant48 mL/min/1.73m2
No-stenosis GroupGraft Function8 years posttransplant46 mL/min/1.73m2
No-stenosis GroupGraft Function5 years posttransplant48 mL/min/1.73m2
No-stenosis GroupGraft Function3 years posttransplant47 mL/min/1.73m2
No-stenosis GroupGraft Function10 years posttransplant50 mL/min/1.73m2
No-stenosis GroupGraft Function7 years posttransplant47 mL/min/1.73m2
No-stenosis GroupGraft Function1 year posttransplant46 mL/min/1.73m2
No-stenosis GroupGraft Function9 years posttransplant46 mL/min/1.73m2
TASC A/B StenosisGraft Function8 years posttransplant50 mL/min/1.73m2
TASC A/B StenosisGraft Function3 years posttransplant47 mL/min/1.73m2
TASC A/B StenosisGraft Function1 year posttransplant51 mL/min/1.73m2
TASC A/B StenosisGraft Function2 years posttransplant50 mL/min/1.73m2
TASC A/B StenosisGraft Function4 years posttransplant41 mL/min/1.73m2
TASC A/B StenosisGraft Function5 years posttransplant40 mL/min/1.73m2
TASC A/B StenosisGraft Function6 years posttransplant46 mL/min/1.73m2
TASC A/B StenosisGraft Function7 years posttransplant45 mL/min/1.73m2
TASC A/B StenosisGraft Function9 years posttransplant46 mL/min/1.73m2
TASC A/B StenosisGraft Function10 years posttransplant35 mL/min/1.73m2
TASC C/D StenosisGraft Function6 years posttransplant46 mL/min/1.73m2
TASC C/D StenosisGraft Function3 years posttransplant40 mL/min/1.73m2
TASC C/D StenosisGraft Function8 years posttransplant47 mL/min/1.73m2
TASC C/D StenosisGraft Function7 years posttransplant40 mL/min/1.73m2
TASC C/D StenosisGraft Function2 years posttransplant42 mL/min/1.73m2
TASC C/D StenosisGraft Function4 years posttransplant42 mL/min/1.73m2
TASC C/D StenosisGraft Function10 years posttransplant48 mL/min/1.73m2
TASC C/D StenosisGraft Function5 years posttransplant38 mL/min/1.73m2
TASC C/D StenosisGraft Function1 year posttransplant46 mL/min/1.73m2
TASC C/D StenosisGraft Function9 years posttransplant50 mL/min/1.73m2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026