Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-05-04 @ 8:53 PM
Study NCT ID:
NCT03142360
Status:
UNKNOWN
Last Update Posted:
2018-05-18
First Post:
2017-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Beraprost Sodium (Berasil) on Hemodialysis
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
Effect of Beraprost Sodium (Berasil) on Hemodialysis
Status:
UNKNOWN
Status Verified Date:
2018-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: