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Efficacy and safety of mycophenolate mofetil after percutaneous angioplasty for arteriovenous fistula stenosis: a prospective, multicenter, randomized controlled clinical trial

Efficacy and safety of mycophenolate mofetil after percutaneous angioplasty for arteriovenous fistula stenosis: a prospective, multicenter, randomized controlled clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042719
Enrollment
Unknown
Registered
2021-01-26
Start date
2021-01-26
Completion date
Unknown
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fistula stenosis in dialysis patients

Interventions

1-month treatment group:Mycophenolate Mofetil
3-month treatment group:Mycophenolate Mofetil

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male or female aged 18-65 (including 18 and 65 years old); 2. The subjects or their legal representatives can understand the purpose of the trial, voluntarily participate in and sign the informed consent, and are willing to accept the follow-up specified in the trial at a specific time point 3. Patients with hemodialysis access dysfunction caused by AVF stenosis indicated by ultrasound, angiography and other imaging examinations or clinical diagnosis 4. Patients with indications for PTA treatment, i.e. AVF diameter stenosis is more than 50%, which is related to hemodynamics, and has one or more of the following clinical and physiological abnormalities: (1) The bleeding or hemostasis time was prolonged after puncture; (2) The venous pressure increased significantly during dialysis; (3) The results showed that the recycling measurement was abnormal; (4) Physical examination was abnormal; (5) Unexplained decrease of dialysis efficiency; (6) Decreased blood flow in vascular access 5. The target lesion is located in the return vein from AVF anastomotic port to the distal end of subclavian vein (except AVF anastomotic port and subclavian vein) 6. Patients with residual stenosis less than 30% after PTA had no stent implantation.

Exclusion criteria

Exclusion criteria: 1. Patients with stenosis or more than 3 lesions in AVF inflow tract and anastomotic stoma; 2. Subjects whose AVF mature time was less than 3 months (failed to use for dialysis or normal blood flow, successful puncture time was less than 3 months); 3. Subjects with systemic active infection or surgical site infection; 4. Subjects with known allergy or intolerance to contrast agent or mycophenolate mofetil; Patients combined with azathioprine; He has received balloon dilatation of internal fistula in the past; 5. Subjects with persistent neutropenia or chronic diarrhea; 6. Subjects who have participated in other clinical trials or refused to participate in the study within 3 months; 7. Subjects who had undergone major surgical operations (cardiothoracic and cranial operations) within 3 months before or 3 months after enrollment; 8. Subjects younger than 18 years old or older than 65 years old; Pregnant or lactating women; Patients who don't want to use contraception. 9. Patients with severe heart and respiratory failure or malignant tumor; Patients with systemic lupus erythematosus and ANCA associated vasculitis; The patient's life expectancy is less than 1 year; 10. Patients with liver dysfunction (ALT / AST > 2 times higher than normal or total bile Red > 44.5 umol / L); Or hepatitis virus is active.

Design outcomes

Primary

MeasureTime frame
AVF re-stenosis rate ;

Countries

China

Contacts

Public ContactTianlei Cui

Nephrology, West China Hospital of Sichuan University

Tianleicui@163.com+86 18980601979

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026