Exploratory Research of PCSK9 Inhibitor on Patency of aAVF After PTA With PCB

NCT06034691 | Unknown

• 1 other identifier: LY2023-113-A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Autologous arteriovenous fistula (AVF) is the preferred vascular pathway type for maintenance hemodialysis (MHD) patients. The K/DOQI guidelines suggest that the use of percutaneous transluminal angioplasty (PTA) as the primary treatment for AVF stenosis is reasonable. However, the durability of PTA is limited. In order to reduce the risk of dysfunction recurrence after the intervention, there have been reports in recent years that drug-coated balloons (DCB) are used in the treatment of vascular stenosis in hemodialysis. Multiple factors have limited the efficacy of DCB. Previous studies on the related factors of hemodialysis access stenosis showed that Dyslipidemia was significantly related to the short initial patency rate, and Dyslipidemia was an important predictor of secondary patency loss. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are a new type of lipid-lowering drug that can prevent vascular calcification. Previous studies have shown that PCSK9 inhibitors have good lipid-lowering effects in both MHD patients and nondialysis patients, and the use of PSK9 inhibitors at the same dose as nondialysis patients is safe in MHD patients. There are currently few studies on the use of paclitaxel-releasing balloon dilation combined with PCSK9 inhibitors to improve autologous internal fistula. Therefore, the investigators applied a prospective, randomized, and controlled study method to preliminarily explore the effect of paclitaxel releasing balloon combined with PCSK9 inhibitor on improving the postoperative patency rate of AVF and the safety of the combined application.

Conditions

Hemodialysis Access Failure

Outcome Measures

Primary Outcomes (4)

• Value of vessel diameter

  ultrasonic measurement

  24 week, 48 week

• Value of volume of blood flow

  ultrasonic measurement

  24 week, 48 week

• Value of peak systolic velocity ratio（PSVR）

  ultrasonic measurement

  24 week, 48 week

• Incidence of Re intervention of fistula

  Event recording

  48 week

Secondary Outcomes (9)

• Endometrium

  24 week, 48 week

• RA

  24 week, 48 week

• BTM

  24 week, 48 week

• Adequacy of dialysis

  24 week, 48 week

• Blood routine

  12 week, 24 week, 48 week

Study Arms (2)

PCSK9i group

EXPERIMENTAL

treatment group

Biological: pcsk9 inhibitor

control group

NO INTERVENTION

control group

Interventions

pcsk9 inhibitor BIOLOGICAL

The treatment group received postoperative use of 140 mg of Ribavirin, administered every two weeks, with 140 mg administered subcutaneously for a total of 48 weeks. There was no additional intervention with lipid-lowering drugs in the control group.

PCSK9i group

Eligibility Criteria

• Age: 17 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Agree to join this study and sign an informed consent form
• Age ≥ 18 years old and ≤ 75 years old, regardless of gender
• Maintenance hemodialysis patients using autologous arteriovenous fistula (AVF), with a dialysis frequency of three times a week
• 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:
• 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
• Unable to meet the required blood flow for dialysis prescription (blood flow\<200ml/min, and cannot be corrected after adjusting the puncture needle position)
• 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)
• 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)
• Decreased dialysis adequacy \[arteriovenous fistula recirculation rate (RA)\>10%, or an increase of more than 25% compared to the previous examination result\] \[RA=(SA-A)/(SA-V) \* 100, dialysis to 1 hour: SA=blood flow adjusted to 20ml/min, ultrafiltration and dialysate flow stopped, after 2 minutes, artery Blood urea nitrogen concentration A=artery Blood urea nitrogen concentration V=vein Blood urea nitrogen concentration\]
• Abnormal signs of fistula.
• 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

You may not qualify if:

• MHD with AVG
• Breastfeeding or Pregnant Women
• Patients with central venous reflux obstruction
• Patients with AVF feeding artery disease
• 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)
• Left ventricular Ejection fraction less than 30% or hemodynamic instability
• Patients receiving immunotherapy or suspected/confirmed Vasculitis
• Patients with coagulation dysfunction or a history of Thrombocytopenic purpura
• Patients with vascular access infections or systemic active infections
• Patients who are known to be allergic to PCSK9 inhibitors or paclitaxel
• Patient's life expectancy is less than 12 months
• Patients who are planning kidney transplantation or switching to Peritoneal dialysis
• Patients participating in other intervention studies
• The researcher judged that the subject's condition was not suitable for participation in this study

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Yuanyuan Xie

Shanghai, Pudong, 200127, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: September 13, 2023
• Study Start: September 10, 2023
• Primary Completion: September 6, 2024
• Study Completion: October 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

CN (1)