Arteriovenous Fistula Patency Clinical Trial
Official title:
Effect of Beraprost Sodium (Berasil) on Hemodialysis
There is no randomized control study to determine if the beneficial effects of beraprost
sodium could improve the patency of arteriovenous fistula in hemodialysis patients.
Therefore, this study is aimed to demonstrate the use of beraprost sodium can improve the
patency of arteriovenous fistula in patients undergoing hemodialysis. This study is
prospectively randomize controlled open-label trials in patients who newly made artificial
arteriovenous fistula for hemodialysis. This study is a pilot study, and the target number of
subjects is 60 in total, 30 in the treatment group and 30 in the control group.
After randomization, the treatment group takes a beraprost sodium for 6 months and the
control group does not take placebo.
Treatment lasts for 6 months after dosing but continues until the patient changes the
renal-replacement therapy method or falls under the exclusion criteria.
The patient should visit at 1, 3, and 6 months after arteriovenous graft surgery to check the
access site after graft surgery. The doppler ultrasound test is performed to measure the
access blood flow rate and patency of arteriovenous fistula.
This study is a prospective randomized controlled open-labeled trial of patients undergoing hemodialysis under the diagnosis of end stage renal disease. The subjects were divided into the treatment group and the control group through random assignment under the condition of receiving hemodialysis steadily and followed up for 6 months. After randomization, the treatment group received beraprost sodium (Berasil) for 6 months (24 weeks) and beraprost sodium will be provided by Astellas Pharma Korea, Inc. Patients were randomly assigned within 2 days after successful arteriovenous graft surgery, and the treatment group started taking 120 mcg of Berasil, while the control group did not take placebo to replace beraprost sodium. ;