Effect of Beraprost Sodium (Berasil) on Hemodialysis

Not Applicable

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment group	Beraprost sodium (Berasil)	Within two days after successful arteriovenous graft surgery, the treatment group is randomly assigned to start taking 120 mcg of Berasil.

Primary Outcome Measures

Name	Time	Method
AVF maturation rate	3 months after arteriovenous graft surgery	Physiologic maturation of the AVF by the definition of AVF access blood flow ≥500mlL/min and AVF diameter ≥4mm at 3 months

Secondary Outcome Measures

Name	Time	Method
AVF failure rate	6 months after arteriovenous graft surgery
Bleeding events	6 months after arteriovenous graft surgery
AVF maturation rate	1 month after arteriovenous graft surgery	Physiologic maturation of the AVF by the definition of AVF access blood flow ≥500mlL/min and AVF diameter ≥4mm at a month
Hemodialysis performed rate	3 months after arteriovenous graft surgery

Locations (1): Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine
🇰🇷
Seoul, Korea, Republic of

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial