Effect of Beraprost Sodium (Berasil) on Hemodialysis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Beraprost Sodium (Berasil) on Hemodialysis

Conditions
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Arteriovenous Fistula Patency

Intervention / Treatment
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* Drug: Beraprost sodium (Berasil)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet all of the following criteria Patient who newly made artificial arteriovenous fistula for hemodialysis Patients who agree to participate in the test and sign a consent form 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment group is randomly assigned to start taking 120 mcg of Berasil. On the other hand, the control group does not take anything.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Within two days after successful arteriovenous graft surgery, the treatment group is randomly assigned to start taking 120 mcg of Berasil. | Drug: Beraprost sodium (Berasil)<br>* Within two days after successful arteriovenous graft surgery, the treatment group is randomly assigned to start taking 120 mcg of Berasil.<br>|
| No Intervention: Non-Treatment group<br>On the other hand, the control group does not take anything. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AVF maturation rate | Physiologic maturation of the AVF by the definition of AVF access blood flow ≥500mlL/min and AVF diameter ≥4mm at 3 months | 3 months after arteriovenous graft surgery | 

Secondary Outcome Measures

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