Effect of Beraprost Sodium (Berasil) on Hemodialysis
Primary Purpose
Arteriovenous Fistula Patency
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Beraprost sodium (Berasil)
Sponsored by
About this trial
This is an interventional treatment trial for Arteriovenous Fistula Patency
Eligibility Criteria
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
Sites / Locations
- Division of Nephrology, Department of Internal Medicine Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment group
Non-Treatment group
Arm Description
Within two days after successful arteriovenous graft surgery, the treatment group is randomly assigned to start taking 120 mcg of Berasil.
On the other hand, the control group does not take anything.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Hemodialysis performed rate
AVF failure rate
Bleeding events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03142360
Brief Title
Effect of Beraprost Sodium (Berasil) on Hemodialysis
Official Title
Effect of Beraprost Sodium (Berasil) on Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
April 4, 2019 (Anticipated)
Study Completion Date
April 4, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula Patency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Within two days after successful arteriovenous graft surgery, the treatment group is randomly assigned to start taking 120 mcg of Berasil.
Arm Title
Non-Treatment group
Arm Type
No Intervention
Arm Description
On the other hand, the control group does not take anything.
Intervention Type
Drug
Intervention Name(s)
Beraprost sodium (Berasil)
Intervention Description
Within two days after successful arteriovenous graft surgery, the treatment group is randomly assigned to start taking 120 mcg of Berasil.
Primary Outcome Measure Information:
Title
AVF maturation rate
Description
Physiologic maturation of the AVF by the definition of AVF access blood flow ≥500mlL/min and AVF diameter ≥4mm at 3 months
Time Frame
3 months after arteriovenous graft surgery
Secondary Outcome Measure Information:
Title
AVF maturation rate
Description
Physiologic maturation of the AVF by the definition of AVF access blood flow ≥500mlL/min and AVF diameter ≥4mm at a month
Time Frame
1 month after arteriovenous graft surgery
Title
Hemodialysis performed rate
Time Frame
3 months after arteriovenous graft surgery
Title
AVF failure rate
Time Frame
6 months after arteriovenous graft surgery
Title
Bleeding events
Time Frame
6 months after arteriovenous graft surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung Tak Park, M.D., Ph.D.
Phone
82-2-2228-2281
Email
jtpark@yuhs.ac
Facility Information:
Facility Name
Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Tak Park, M.D., Ph,D
Phone
82-2-2228-2281
Email
jtpark@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23474008
Citation
Lin CC, Yang WC, Chen MC, Liu WS, Yang CY, Lee PC. Effect of far infrared therapy on arteriovenous fistula maturation: an open-label randomized controlled trial. Am J Kidney Dis. 2013 Aug;62(2):304-11. doi: 10.1053/j.ajkd.2013.01.015. Epub 2013 Mar 6.
Results Reference
background
PubMed Identifier
24066672
Citation
Na KY, Kim DK, Kim SG, Lee YK, Lim CS. Effect of beraprost sodium on arterial stiffness in patients with type 2 diabetic nephropathy. Trials. 2013 Sep 2;14:275. doi: 10.1186/1745-6215-14-275.
Results Reference
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PubMed Identifier
19458364
Citation
Dixon BS, Beck GJ, Vazquez MA, Greenberg A, Delmez JA, Allon M, Dember LM, Himmelfarb J, Gassman JJ, Greene T, Radeva MK, Davidson IJ, Ikizler TA, Braden GL, Fenves AZ, Kaufman JS, Cotton JR Jr, Martin KJ, McNeil JW, Rahman A, Lawson JH, Whiting JF, Hu B, Meyers CM, Kusek JW, Feldman HI; DAC Study Group. Effect of dipyridamole plus aspirin on hemodialysis graft patency. N Engl J Med. 2009 May 21;360(21):2191-201. doi: 10.1056/NEJMoa0805840.
Results Reference
background
PubMed Identifier
26084116
Citation
Vicil S, Erdogan S. Beraprost sodium, a prostacyclin (PGI) analogue, ameliorates lipopolysaccharide-induced cellular injury in lung alveolar epithelial cells. Turk J Med Sci. 2015;45(2):284-90. doi: 10.3906/sag-1401-108.
Results Reference
background
PubMed Identifier
23749750
Citation
Arai T. Long-term effects of beraprost sodium on arteriosclerosis obliterans: a single-center retrospective study of Japanese patients. Adv Ther. 2013 May;30(5):528-40. doi: 10.1007/s12325-013-0030-7. Epub 2013 Jun 8.
Results Reference
background
PubMed Identifier
16247707
Citation
Murakami M, Watanabe M, Furukawa H, Nakahara H. The prostacyclin analogue beraprost sodium prevents occlusion of bypass grafts in patients with lower extremity arterial occlusive disease: a 20-year retrospective study. Ann Vasc Surg. 2005 Nov;19(6):838-42. doi: 10.1007/s10016-005-7668-9.
Results Reference
background
PubMed Identifier
25175122
Citation
Sakao S, Tanabe N, Kasahara Y, Tatsumi K. Long-term survival of Japanese patients with pulmonary arterial hypertension treated with beraprost sodium, an oral prostacyclin analogue. Intern Med. 2014;53(17):1913-20. doi: 10.2169/internalmedicine.53.2573. Epub 2014 Sep 1.
Results Reference
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Effect of Beraprost Sodium (Berasil) on Hemodialysis
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