Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2017-04-05
2019-04-04
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment group
Within two days after successful arteriovenous graft surgery, the treatment group is randomly assigned to start taking 120 mcg of Berasil.
Beraprost sodium (Berasil)
Within two days after successful arteriovenous graft surgery, the treatment group is randomly assigned to start taking 120 mcg of Berasil.
Non-Treatment group
On the other hand, the control group does not take anything.
No interventions assigned to this group
Interventions
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Beraprost sodium (Berasil)
Within two days after successful arteriovenous graft surgery, the treatment group is randomly assigned to start taking 120 mcg of Berasil.
Eligibility Criteria
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Inclusion 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 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
19 Years
79 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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4-2017-0129
Identifier Type: -
Identifier Source: org_study_id
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