Aorto-Iliac Arterial StenosisTASCNCT06020534
Aortoiliac Stenosis in Kidney Transplantation
An observational study of Aorto-Iliac Arterial Stenosis and Peripheral Arterial Disease, run by Erasmus Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aorto-Iliac Arterial Stenosis, Peripheral Arterial Disease, Kidney Transplant Failure
- How many people
- 655 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020.
Who may be able to join
- Patients who underwent kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020
Who cannot join
- Patients who were under 18 years at transplantation
- Patients who underwent combined organ transplantation
- Patients who had no follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Kidney Transplantation in Patients With Aortoiliac Stenosis
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.
Read the 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.
- Keywords
- aortoiliac arterial stenosis, peripheral arterial disease, kidney transplantation, outcomes
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No-stenosis group | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.
Secondary outcomes (2)
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.
Measured: From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.
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.
Measured: From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Jan 2022
- Primary completion31 Jan 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aorto-Iliac Arterial StenosisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 655 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yitian Fang, MD, Erasmus Medical Center
- Investigators
- Yitian Fang, MD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020534
- Sponsor's protocol ID
- KT TASC
- Acronym
- TASC
- Status last verified
- Dec 2024
- First submitted
- 24 Aug 2023
- Last updated
- 7 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support this study are not publicly available due to reasons of sensitivity and are available from the principal investigator upon reasonable request.
Publications
Fang Y, Hamm JJM, den Hartog FPJ, Kimenai HJAN, de Bruin RWF, Minnee RC. Safety and efficacy of kidney transplantation in patients with aortoiliac stenosis: a retrospective cohort study. Int J Surg. 2024 Feb 1;110(2):992-999. doi: 10.1097/JS9.0000000000000926.
PubMed 38016127
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Kidney Transplantation in Patients With Aortoiliac Stenosis
- ClinicalTrials.gov ID
- NCT06020534
- Acronym / sponsor ID
- TASC / KT TASC
- Keywords
- aortoiliac arterial stenosis, peripheral arterial disease, kidney transplantation, outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 655 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Posted 12 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No-stenosis group | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020.
Key inclusion criteria (1 listed)
- Patients who underwent kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020
Key exclusion criteria (3 listed)
- Patients who were under 18 years at transplantation
- Patients who underwent combined organ transplantation
- Patients who had no follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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.
Graft Function
Time frame: From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38016127Fang Y, Hamm JJM, den Hartog FPJ, Kimenai HJAN, de Bruin RWF, Minnee RC. Safety and efficacy of kidney transplantation in patients with aortoiliac stenosis: a retrospective cohort study. Int J Surg. 2024 Feb 1;110(2):992-999. doi: 10.1097/JS9.0000000000000926.
- Individual participant dataSharing planned: No. The data that support this study are not publicly available due to reasons of sensitivity and are available from the principal investigator upon reasonable request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yitian Fang, MD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aorto-Iliac Arterial Stenosis and Peripheral Arterial Disease, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Survival (time frame: From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06020534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.