End-Stage Renal Disease
Conditions
Interventions
treatment:MMF 0.5g q12h
Control:Placebo 0.5g q12h
Sponsors
Department of Nephrology, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patient must be 18 years of age or older at the time of signing and dating informed consent and be less than 65 years old, can be male or female; 2. Patient or his legal representative must understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent, and are willing to accept the specified follow-up at a certain time; 3. Patient must have a dysfunction of its hemodialysis vascular access due to AVF stenosis diagnosed by the imaging examination or clinical physical examination; 4. Patient must have the indication of PTA for AVF stenosis,defined by: fistula stenosis >50% combined with hemodynamic dysfunction :and/or 20% decrease in access flow as monitored during dialysis or by Duplex ultrasound scan, and/or dialysis recirculation; and/or thrill not perceived; and/or pulsatile vascular access; and/or bleeding or increased bleeding time after puncture; 5. A stenosis >50% of the venous line must be diagnosed between fistula and the distal end of the subclavian vein; 6. A successful plain balloon angioplasty of the stenosis, defined by residual stenosis <30% on control angiogram, without dissection or indication for use of stent or additional surgical procedure, must be completed before inclusion.
Exclusion criteria
Exclusion criteria: 1. Vascular access has sentosis in Inflow and anastomosis or multiple sentosis( location >3); 2. AVF maturation dysfunction( the fistula cannot be used for dialysis or less than 3 months); 3. Patient has active systemic infection or surgical site infection; 4. Patient has been sensitive to the contrast agent or MMF; 5. Patient has granuloaytopenia or chronic diarrhea; 6. Patient has been operated the major surgery(such as Cardiothoracic Surgery or Neursurgery) or would be in three months; 7. Pregnant or nursing woman, or plans to become pregnant during the study; 8. Patient has suffered a debilitating series of heart and lung ailments or the cancer at the time of inclusion; 9. Patient has suffered major liver function damage or active hepatitis B or C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency rate;re-setnosis rate; | — |
Countries
China
Contacts
Public ContactCui Tianlei
Department of Nephrology, West China Hospital, Sichuan University
Outcome results
None listed