Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06112821
Other study ID # AVF Maturation-aPL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date June 30, 2024

Study information

Verified date October 2023
Source Brugmann University Hospital
Contact Maxime Taghavi
Phone 024752646
Email Maxime.TAGHAVI@chu-brugmann.be
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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. 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: Incident patients with chronic kidney disease (CKD) on stage G3b to G5, not end-stage renal disease, according to KDIGO guidelines Exclusion Criteria: - 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...)

Study Design


Intervention

Other:
Data collection in medical records
Data collection in medical records
Blood sampling
Blood plasma and serum collection for biobanking. Future laboratory analyses encompass the analysis of endothelial dysfunction markers and other markers implicated in APS.

Locations

Country Name City State
Belgium Brugmann University Hospital Brussels

Sponsors (1)

Lead Sponsor Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary AVF maturation status AVF maturation status according to KDIGO guidelines, evaluated by means of ultrasound/doppler (outflow, diameter, stenosis and/or thrombosis) 6 weeks
Secondary Functional primary patency of AVF Time between of AVF first use and AVF complication necessitating intervention 1 year
Secondary Type of AVF complication AVF Thrombosis Identification of AVF complication: thrombosis/stenosis/bleeding complications/intimal hyperplasia dysfunction 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT06386172 - Electronic Decision-support System to Improve Detection and Care of Patients With Chronic Kidney Disease in Stockholm N/A
Recruiting NCT04910867 - APOL1 Genetic Testing Program for Living Donors N/A
Completed NCT03434145 - Changes of Ocular Structures After Hemodialysis in Patients With Chronic Kidney Diseases N/A
Recruiting NCT04984226 - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD Phase 2
Active, not recruiting NCT05887817 - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR) Phase 4
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Terminated NCT05022329 - COVID-19 Vaccine Boosters in Patients With CKD Phase 2/Phase 3
Not yet recruiting NCT04925661 - HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia Phase 1
Recruiting NCT04961164 - Resistant Starch Prebiotic Effects in Chronic Kidney Disease N/A
Completed NCT05015647 - Low Protein Diet in CKD Patients at Risk of Malnutrition N/A
Completed NCT03426787 - Helping Empower Liver and Kidney Patients N/A
Recruiting NCT06094231 - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study N/A
Completed NCT04363554 - The Kidneys Ability to Concentrate and Dilute Urine in Patients With Autosomal Dominant Polycystic Kidney Disease N/A
Recruiting NCT04831021 - Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role? N/A
Terminated NCT04877847 - Multi-Center Trial Utilizing Low Frequency Ultrasound in the Prevention of Post-Contrast Acute Kidney Injury N/A
Recruiting NCT04422652 - Combination of Novel Therapies for CKD Comorbid Depression Phase 2
Completed NCT05055362 - Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study N/A
Not yet recruiting NCT06330480 - Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease N/A
Recruiting NCT03176862 - Left Ventricular Fibrosis in Chronic Kidney Disease N/A
Terminated NCT02539680 - Intestinal Phosphate Transporter Expression in CKD Patients N/A