Arteriovenous Fistula Patency Clinical Trial
Official title:
Effect of Beraprost Sodium (Berasil) on Hemodialysis
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | April 4, 2019 |
| Est. primary completion date | April 4, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years to 79 Years |
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
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. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2014 Sep 1. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | Hemodialysis performed rate | 3 months after arteriovenous graft surgery | ||
| Secondary | AVF failure rate | 6 months after arteriovenous graft surgery | ||
| Secondary | Bleeding events | 6 months after arteriovenous graft surgery |