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Hemodialysis Access FailureNCT06034691

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

A study testing pcsk9 inhibitor in people with Hemodialysis Access Failure, run by RenJi Hospital at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. Read more about this study

Who is it for?
Ages 17 to 76 years
Conditions the study is for
Hemodialysis Access Failure
What is being tested?
pcsk9 inhibitor
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
10 Sep 2023to 1 Oct 2024
Phase
Interventional
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 17 to 76 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Yuanyuan Xie

    Shanghai, Pudong, 200127

    Yuanyuan Xie, +86 13601852981, xieyuanyuan@renji.com

    Recruiting

Other trials in China

About this study

Official title: Exploratory Research of PCSK9 Inhibitor on Patency of Autogenous Arteriovenous Fistula After Percutaneous Transluminal Angioplasty With Paclitaxel Releasing Balloon

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.

Being tested
pcsk9 inhibitor

What participants receive

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

  • pcsk9 inhibitorBiological

    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.

Study groups in NCT06034691
Study groupRoleWhat they receive
PCSK9i groupExperimentaltreatment group
Receives: Biological: pcsk9 inhibitor
control groupNo interventioncontrol group

What is being measured

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

  1. Value of vessel diameter

    ultrasonic measurement

    Measured: 24 week, 48 week

  2. Value of volume of blood flow

    ultrasonic measurement

    Measured: 24 week, 48 week

  3. Value of peak systolic velocity ratio（PSVR）

    ultrasonic measurement

    Measured: 24 week, 48 week

  4. Incidence of Re intervention of fistula

    Event recording

    Measured: 48 week

Secondary outcomes (9)

  1. Endometrium

    Ultrasonic measurement of changes in thickness of vascular intima , expressed in millimeters

    Measured: 24 week, 48 week

  2. RA

    Arteriovenous fistula recirculation rate

    Measured: 24 week, 48 week

  3. BTM

    Blood temperature monitoring, testing of specific modules of the hemodialysis machine. Expressed as a percentage.

    Measured: 24 week, 48 week

  4. Adequacy of dialysis

    spKT/V

    Measured: 24 week, 48 week

  5. Blood routine

    Concentration of hemoglobin, white blood cell count, platelet

    Measured: 12 week, 24 week, 48 week

  6. liver function

    Concentration of GPT, GOT

    Measured: 12 week, 24 week, 48 week

  7. Concentration of blood sugar

    Measured: 12 week, 24 week, 48 week

  8. Concentration of CRP

    Measured: 12 week, 24 week, 48 week

  9. blood lipids

    Concentration of cholesterol, triglyceride, LDL-c, HDL

    Measured: 12 week, 24 week, 48 week

Timeline

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

  1. First posted13 Sep 2023
  2. Study start10 Sep 2023 (estimated)
  3. Primary completion6 Sep 2024 (estimated)
  4. Study completion1 Oct 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
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06034691
Sponsor's protocol ID
LY2023-113-A
Status last verified
Sep 2023
First submitted
14 Aug 2023
Last updated
13 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing pcsk9 inhibitor in people with Hemodialysis Access Failure, run by RenJi Hospital at 1 site in China.

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 11 inclusion and 14 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 13 Sep 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 China. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Value of vessel diameter (time frame: 24 week, 48 week). The study lists 4 primary outcomes in all. 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 NCT06034691.

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 13 Sep 2023.

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