Effect of Beraprost Sodium (Berasil) on Hemodialysis

• Status: Unknown status
• Trial end date: 2019-04-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Beraprost; Epoprostenol

Criteria

Inclusion Criteria:

• Patients who meet all of the following criteria

1. Patient who newly made artificial arteriovenous fistula for hemodialysis

2. Patients who agree to participate in the test and sign a consent form

3. Patients who had diabetes

Exclusion Criteria:

• Patients under 18 years old, 80 years old or older

• Patients with a high risk of bleeding (hemophilia, capillary weakness, upper gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.)

• Women who are pregnant or have a possibility of pregnancy

• Platelet count ≤ 75000

• Patients taking anticoagulants or antithrombotics

• Patients with galactose intolerance, lactase deficiency or glucose-galactose malabsorption