Trial Outcomes & Findings for Aortoiliac Stenosis in Kidney Transplantation (NCT NCT06020534)
NCT ID: NCT06020534
Last Updated: 2025-01-07
Results Overview
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.
COMPLETED
655 participants
From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.
2025-01-07
Participant Flow
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.
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.
Participant milestones
| Measure |
No-stenosis Group
After PSM, 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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
524
|
96
|
35
|
|
Overall Study
COMPLETED
|
524
|
96
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
No-stenosis Group
n=524 Participants
Patients who had no pre-existing aortoiliac stenosis before kidney transplantation.
|
TASC A/B Stenosis Group
n=96 Participants
Patients who had TASC A/B aortoiliac stenosis before kidney transplantation.
|
TASC C/D Stenosis Group
n=35 Participants
Patients who had TASC C/D aortoiliac stenosis before kidney transplantation.
|
Total
n=655 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66 years
n=524 Participants
|
66 years
n=96 Participants
|
63 years
n=35 Participants
|
66 years
n=655 Participants
|
|
Sex: Female, Male
Female
|
169 Participants
n=524 Participants
|
34 Participants
n=96 Participants
|
10 Participants
n=35 Participants
|
213 Participants
n=655 Participants
|
|
Sex: Female, Male
Male
|
355 Participants
n=524 Participants
|
62 Participants
n=96 Participants
|
25 Participants
n=35 Participants
|
442 Participants
n=655 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
28 kg/m2
n=524 Participants
|
27 kg/m2
n=96 Participants
|
28 kg/m2
n=35 Participants
|
28 kg/m2
n=655 Participants
|
|
Type of Dialysis
Pre-emptive
|
120 Participants
n=524 Participants
|
24 Participants
n=96 Participants
|
5 Participants
n=35 Participants
|
149 Participants
n=655 Participants
|
|
Type of Dialysis
Hemodialysis
|
297 Participants
n=524 Participants
|
52 Participants
n=96 Participants
|
22 Participants
n=35 Participants
|
371 Participants
n=655 Participants
|
|
Type of Dialysis
Peritoneal Dialysis
|
69 Participants
n=524 Participants
|
12 Participants
n=96 Participants
|
5 Participants
n=35 Participants
|
86 Participants
n=655 Participants
|
|
Type of Dialysis
Combined Modality
|
38 Participants
n=524 Participants
|
8 Participants
n=96 Participants
|
3 Participants
n=35 Participants
|
49 Participants
n=655 Participants
|
|
Duration of Dialysis
|
22 months
n=524 Participants
|
22 months
n=96 Participants
|
26 months
n=35 Participants
|
22 months
n=655 Participants
|
|
Retransplant
|
87 Participants
n=524 Participants
|
15 Participants
n=96 Participants
|
6 Participants
n=35 Participants
|
108 Participants
n=655 Participants
|
|
Donor Type
Living Donor
|
290 Participants
n=524 Participants
|
55 Participants
n=96 Participants
|
15 Participants
n=35 Participants
|
360 Participants
n=655 Participants
|
|
Donor Type
DBD
|
87 Participants
n=524 Participants
|
15 Participants
n=96 Participants
|
6 Participants
n=35 Participants
|
108 Participants
n=655 Participants
|
|
Donor Type
DCD
|
147 Participants
n=524 Participants
|
26 Participants
n=96 Participants
|
14 Participants
n=35 Participants
|
187 Participants
n=655 Participants
|
|
Smoking Status
Never Smoker
|
150 Participants
n=524 Participants
|
25 Participants
n=96 Participants
|
13 Participants
n=35 Participants
|
188 Participants
n=655 Participants
|
|
Smoking Status
Former Smoker
|
261 Participants
n=524 Participants
|
50 Participants
n=96 Participants
|
15 Participants
n=35 Participants
|
326 Participants
n=655 Participants
|
|
Smoking Status
Current Smoker
|
113 Participants
n=524 Participants
|
21 Participants
n=96 Participants
|
7 Participants
n=35 Participants
|
141 Participants
n=655 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
No-stenosis Group
n=524 Participants
Patients who had no pre-existing aortoiliac stenosis before kidney transplantation.
|
TASC A/B Stenosis
n=96 Participants
Patients who had TASC A or B aortoiliac stenosis before kidney transplantation.
|
TASC C/D Stenosis
n=35 Participants
Patients who had TASC C or D aortoiliac stenosis before kidney transplantation.
|
|---|---|---|---|
|
Patient Survival
|
322 Participants
|
48 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
No-stenosis Group
n=524 Participants
Patients who had no pre-existing aortoiliac stenosis before kidney transplantation.
|
TASC A/B Stenosis
n=96 Participants
Patients who had TASC A or B aortoiliac stenosis before kidney transplantation.
|
TASC C/D Stenosis
n=35 Participants
Patients who had TASC C or D aortoiliac stenosis before kidney transplantation.
|
|---|---|---|---|
|
Death-censored Graft Survival
|
443 Participants
|
80 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
No-stenosis Group
n=476 Participants
Patients who had no pre-existing aortoiliac stenosis before kidney transplantation.
|
TASC A/B Stenosis
n=81 Participants
Patients who had TASC A or B aortoiliac stenosis before kidney transplantation.
|
TASC C/D Stenosis
n=28 Participants
Patients who had TASC C or D aortoiliac stenosis before kidney transplantation.
|
|---|---|---|---|
|
Graft Function
1 year posttransplant
|
46 mL/min/1.73m2
Interval 35.0 to 59.0
|
51 mL/min/1.73m2
Interval 40.0 to 61.0
|
46 mL/min/1.73m2
Interval 35.0 to 54.0
|
|
Graft Function
2 years posttransplant
|
46 mL/min/1.73m2
Interval 35.0 to 59.0
|
50 mL/min/1.73m2
Interval 37.0 to 63.0
|
42 mL/min/1.73m2
Interval 30.0 to 52.0
|
|
Graft Function
3 years posttransplant
|
47 mL/min/1.73m2
Interval 34.0 to 61.0
|
47 mL/min/1.73m2
Interval 33.0 to 61.0
|
40 mL/min/1.73m2
Interval 35.0 to 45.0
|
|
Graft Function
4 years posttransplant
|
48 mL/min/1.73m2
Interval 35.0 to 62.0
|
41 mL/min/1.73m2
Interval 32.0 to 59.0
|
42 mL/min/1.73m2
Interval 29.0 to 50.0
|
|
Graft Function
5 years posttransplant
|
48 mL/min/1.73m2
Interval 36.0 to 61.0
|
40 mL/min/1.73m2
Interval 28.0 to 59.0
|
38 mL/min/1.73m2
Interval 33.0 to 48.0
|
|
Graft Function
6 years posttransplant
|
47 mL/min/1.73m2
Interval 35.0 to 62.0
|
46 mL/min/1.73m2
Interval 30.0 to 60.0
|
46 mL/min/1.73m2
Interval 31.0 to 49.0
|
|
Graft Function
7 years posttransplant
|
47 mL/min/1.73m2
Interval 34.0 to 65.0
|
45 mL/min/1.73m2
Interval 26.0 to 56.0
|
40 mL/min/1.73m2
Interval 30.0 to 47.0
|
|
Graft Function
8 years posttransplant
|
46 mL/min/1.73m2
Interval 32.0 to 64.0
|
50 mL/min/1.73m2
Interval 39.0 to 58.0
|
47 mL/min/1.73m2
Interval 44.0 to 57.0
|
|
Graft Function
9 years posttransplant
|
46 mL/min/1.73m2
Interval 33.0 to 62.0
|
46 mL/min/1.73m2
Interval 40.0 to 55.0
|
50 mL/min/1.73m2
Interval 49.0 to 58.0
|
|
Graft Function
10 years posttransplant
|
50 mL/min/1.73m2
Interval 30.0 to 61.0
|
35 mL/min/1.73m2
Interval 25.0 to 43.0
|
48 mL/min/1.73m2
Interval 40.0 to 59.0
|
Adverse Events
No-stenosis Group
TASC A/B Stenosis
TASC C/D Stenosis
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place