Evaluating arteriovenous fistula maturation in hemodialysis patients with antiphospholipid antibodies
Arteriovenous Fistula Maturation in Hemodialysis Patients With or Without Positive Antiphospholipid Antibodies : A Prospective Observational Cohort Study.
This study is trying to see how having antiphospholipid antibodies affects the growth and development of arteriovenous fistulas in patients with chronic kidney disease who need hemodialysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Brugmann University Hospital Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT06112821 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the maturation process of arteriovenous fistulas (AVF) in patients with chronic kidney disease who may or may not have positive antiphospholipid antibodies. The study focuses on the vascular remodeling that occurs after AVF creation, which is essential for establishing effective hemodialysis access. Researchers will collect data from medical records and perform blood sampling to assess the maturation criteria defined by the Kidney Disease Outcomes Quality Initiative (KDOQI). The goal is to understand how the presence of antiphospholipid antibodies affects the maturation of AVF in these patients.
Who should consider this trial
Good fit: Ideal candidates include incident patients with chronic kidney disease stages G3b to G5 who are not yet on hemodialysis.
Not a fit: Patients already on hemodialysis or those with contraindications for AVF creation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding of AVF maturation, leading to better hemodialysis access and outcomes for patients with chronic kidney disease.
How similar studies have performed: While studies on AVF maturation exist, the specific focus on the impact of antiphospholipid antibodies is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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...)
Where this trial is running
Brussels
- Brugmann University Hospital — Brussels, Belgium (Recruiting)
Study contacts
- Study coordinator: Maxime Taghavi
- Email: Maxime.TAGHAVI@chu-brugmann.be
- Phone: 024752646
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.