Using PCSK9 inhibitors to improve the success of hemodialysis access
Exploratory Research of PCSK9 Inhibitor on Patency of Autogenous Arteriovenous Fistula After Percutaneous Transluminal Angioplasty With Paclitaxel Releasing Balloon
This study is testing if a cholesterol-lowering medication can help keep dialysis access points open longer for patients who have had trouble with them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 17 Years to 76 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Shanghai, Pudong) |
| Trial ID | NCT06034691 on ClinicalTrials.gov |
What this trial studies
This study explores the use of PCSK9 inhibitors in patients undergoing maintenance hemodialysis with autologous arteriovenous fistulas (AVF) who experience stenosis. The research aims to determine if these lipid-lowering drugs can enhance the patency of AVFs after treatment with percutaneous transluminal angioplasty (PTA). By addressing dyslipidemia, which has been linked to reduced patency rates, the study seeks to improve long-term outcomes for patients with hemodialysis access failure. Participants will be monitored for changes in blood flow and vascular health following treatment.
Who should consider this trial
Good fit: Ideal candidates are maintenance hemodialysis patients aged 18 to 75 with AVF venous stenosis requiring intervention.
Not a fit: Patients who do not have AVF stenosis or are outside the age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the longevity and effectiveness of hemodialysis access for patients.
How similar studies have performed: Previous studies have indicated that addressing dyslipidemia can improve vascular outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Agree to join this study and sign an informed consent form 2. Age ≥ 18 years old and ≤ 75 years old, regardless of gender 3. Maintenance hemodialysis patients using autologous arteriovenous fistula (AVF), with a dialysis frequency of three times a week 4. AVF venous stenosis: The local stenosis rate exceeds 50% of the normal diameter of nearby blood vessels and is accompanied by at least one of the following conditions: 1. The natural blood flow of the internal fistula is less than 500ml/min or has decreased by more than 25% compared to the previous examination result 2. Unable to meet the required blood flow for dialysis prescription (blood flow\<200ml/min, and cannot be corrected after adjusting the puncture needle position) 3. Decreased arterial pressure or increased venous pressure during dialysis (monitoring arterial pressure\<-120mmHg for more than 2 consecutive times or monitoring venous pressure\>120mmHg while maintaining 200ml/min blood flow) 4. Difficulty in puncture: A qualified nurse who has difficulty puncturing for 3 consecutive days of hemodialysis (blood can only be drawn out after more than two punctures) 5. Decreased dialysis adequacy \[arteriovenous fistula recirculation rate (RA)\>10%, or an increase of more than 25% compared to the previous examination result\] \[RA=(SA-A)/(SA-V) \* 100, dialysis to 1 hour: SA=blood flow adjusted to 20ml/min, ultrafiltration and dialysate flow stopped, after 2 minutes, artery Blood urea nitrogen concentration A=artery Blood urea nitrogen concentration V=vein Blood urea nitrogen concentration\] 6. Abnormal signs of fistula. 5. Patients with primary Hypercholesterolemia \[LDL-C ≥ 130 mg/dl (≥ 3.4 mmol/L), and/or non-HDL-C≥ 160 mg/dl (≥ 4.1 mmol/L)\] or combine cardiovascular disease or assess patients with a high risk of cardiovascular disease Exclusion Criteria: 1. MHD with AVG 2. Breastfeeding or Pregnant Women 3. Patients with central venous reflux obstruction 4. Patients with AVF feeding artery disease 5. Patients with severe Hypotension (systolic blood pressure\<90mmHg or diastolic blood pressure\<60mmHg, at least three times within one month before signing the informed consent) 6. Left ventricular Ejection fraction less than 30% or hemodynamic instability 7. Patients receiving immunotherapy or suspected/confirmed Vasculitis 8. Patients with coagulation dysfunction or a history of Thrombocytopenic purpura 9. Patients with vascular access infections or systemic active infections 10. Patients who are known to be allergic to PCSK9 inhibitors or paclitaxel 11. Patient's life expectancy is less than 12 months 12. Patients who are planning kidney transplantation or switching to Peritoneal dialysis 13. Patients participating in other intervention studies 14. The researcher judged that the subject's condition was not suitable for participation in this study
Where this trial is running
Shanghai, Pudong
- Yuanyuan Xie — Shanghai, Pudong, China (Recruiting)
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.