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Chronic Kidney DiseasesNCT06112821

Arteriovenous Fistula Maturation in Hemodialysis Patients With or Without Positive Antiphospholipid Antibodies

An observational study of Chronic Kidney Diseases, run by Brugmann University Hospital at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Hemodialysis (HD) is one of the most often used modalities of blood epuration in ends-stage renal diseases (ESRD) and requires the creation of a patent vascular access such as an arteriovenous fistula (AVF). Native AVF is associated with lower morbidity and mortality compared to hemocatheters. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Kidney Diseases
What is being tested?
Data collection in medical records and Blood sampling
How many people
100 participants
Where
1 siteBelgium
Study dates
1 Jul 2022to 30 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Incident patients with chronic kidney disease (CKD) on stage G3b to G5, not end-stage renal disease, according to KDIGO guidelines and aged from 18 to 75 years old.

Who may be able to join

  • Incident patients with chronic kidney disease (CKD) on stage G3b to G5, not end-stage renal disease, according to KDIGO guidelines

Who cannot join

  • Patient already on hemodialysis maintenance therapy, or switching from peritoneal dialysis to hemodialysis
  • Arteriovenous fistula creation not feasible surgically or technically, or surgery contra-indicated
  • Known thrombophilia other than antiphospholipid syndrome
  • Active neoplasia
  • aPL assays not relevant (treatment, inflammatory state, etc...)

Trial locations and contacts

1 site in 1 country.

Belgium1 site, 1 recruiting
  • Brugmann University Hospital

    Brussels, 1020

    Maxime Taghavi, MD PhD, Maxime.TAGHAVI@chu-brugmann.be

    Recruiting

Other trials in Belgium

About this study

Official title: Arteriovenous Fistula Maturation in Hemodialysis Patients With or Without Positive Antiphospholipid Antibodies : A Prospective Observational Cohort Study.

Hemodialysis (HD) is one of the most often used modalities of blood epuration in ends-stage renal diseases (ESRD) and requires the creation of a patent vascular access such as an arteriovenous fistula (AVF). Native AVF is associated with lower morbidity and mortality compared to hemocatheters.

AVF need a maturation process before its use. This process usually requires less than 6 weeks and consists in a complex vascular remodeling process. Maturation can be considered as the process leading to a newly created AVF being usable for hemodialysis; it encompasses enlargement and thickening of the draining fistula vein, increasing the blood flow in the absence of thrombosis and bleeding. According to the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, AVF is considered matured (and therefore usable for HD) if 6 weeks after AVF creation surgery: (a) its diameter is at least 6mm, (b) its depth less than 6mm, (c) flow rate is at least 600ml/min and (d) its length is at least 6cm in order to allow a two needles cannulation. Delayed AVF maturation is a major complication that affects more than half of the AVF. It can be defined as the delay or absence of maturation according to KDOQI guidelines. The pathophysiology of delay or absence of AVF maturation is complex and multifactorial. It mainly involves thrombosis, stenosis, endothelial dysfunction, and hypercoagulability states.

Read more

In order to promote AVF maturation, the 2019 ERA-EDTA Clinical practice guidelines on peri- and postoperative care of native AVF and grafts for HD in adults, propose some medical treatments.

Antiphospholipid syndrome (APS) is an autoimmune disease, characterized by a prothrombotic state affecting both arterial and venous vasculature. Classification criteria have been proposed in 2006. In HD patient, up to 37% of patients have persistent aPL positivity. aPL positivity has been associated with vascular access thrombosis in retrospective studies.

The investigators performed a retrospective analysis of 113 patients in the HD department of the Brugmann Hospital between 01/01/2019 and 01/08/2019. Unpublished data that are currently under evaluation for publication, showed that the prevalence of APS and antiphospholipid antibody positivity (aPL) without APS, was 18.5% and the prevalence of APS was 10.7%. Antiphospholipid antibody positivity was identified as a risk factor for delayed AVF maturation. In multivariate analysis, antiphospholipid antibody positivity and stenosis were both independent risk factors for delayed maturation. There is a statistically significant association between delayed native AVF maturation and antiphospholipid antibody positivity. This association was independent of arteriovenous stenosis. This data suggest a potential non-stenotic and/or non-thrombotic mechanism of aPL related delayed maturation of the AVF in HD patients. More interestingly, a significant association between aPL positivity (with or without antiphospholipid syndrome) and delayed AVF maturation was found. This association was independent of stenosis.

Considering this association between aPL and failure of native AVF maturation, the aim of the present study is to further evaluate this association in a prospective cohort and to further identify a potential treatment option in order to reduce the prevalence of this very common complication '(i.e. AVF delay or absence of maturation).

Being tested
Data collection in medical records, Blood sampling
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Data collection in medical recordsOther

    Data collection in medical records

  • Blood samplingOther

    Blood plasma and serum collection for biobanking. Future laboratory analyses encompass the analysis of endothelial dysfunction markers and other markers implicated in APS.

Study groups in NCT06112821
Study groupRoleWhat they receive
APL negativePatients without persistent antiphospholipid antibodies (aPL) positivity
Receives: Other: Data collection in medical records; Other: Blood sampling
APL positivePatients with persistent antiphospholipid antibodies (aPL) positivity
Receives: Other: Data collection in medical records; Other: Blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AVF maturation status

    AVF maturation status according to KDIGO guidelines, evaluated by means of ultrasound/doppler (outflow, diameter, stenosis and/or thrombosis)

    Measured: 6 weeks

Secondary outcomes (2)
  1. Functional primary patency of AVF

    Time between of AVF first use and AVF complication necessitating intervention

    Measured: 1 year

  2. Type of AVF complication AVF Thrombosis

    Identification of AVF complication: thrombosis/stenosis/bleeding complications/intimal hyperplasia dysfunction

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2023
  2. Study start1 Jul 2022
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

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
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06112821
Sponsor's protocol ID
AVF Maturation-aPL
Status last verified
Oct 2023
First submitted
27 Oct 2023
Last updated
2 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Taghavi M, Jacobs L, Kaysi S, Dernier Y, Cubilier E, Chebli L, Laureys M, Collart F, Demulder A, Antoine MH, Nortier J. Assessment of Arteriovenous Fistula Maturation in Hemodialysis Patients with Persistently Positive Antiphospholipid Antibody: A Prospective Observational Cohort Study. Life (Basel). 2025 Jan 24;15(2):168. doi: 10.3390/life15020168.

    PubMed 40003577

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Diseases, run by Brugmann University Hospital at 1 site in Belgium.

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 5 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. 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 Belgium. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Maxime Taghavi (024752646, Maxime.TAGHAVI@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AVF maturation status (time frame: 6 weeks). 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 NCT06112821, 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 2 Nov 2023.

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