Effect of Beraprost Sodium (Berasil) on Hemodialysis

NCT03142360 | Unknown

• 1 other identifier: 4-2017-0129
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Arteriovenous Fistula Patency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• AVF maturation rate

  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

Study Arms (2)

Treatment group

EXPERIMENTAL

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)

Non-Treatment group

NO INTERVENTION

On the other hand, the control group does not take anything.

Interventions

Beraprost sodium (Berasil) DRUG

Within two days after successful arteriovenous graft surgery, the treatment group is randomly assigned to start taking 120 mcg of Berasil.

Treatment group

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine

Seoul, 120-752, South Korea

RECRUITING

Related Publications (7)

• 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.

  PMID: 23474008 BACKGROUND

• 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.

  PMID: 24066672 BACKGROUND

• 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.

  PMID: 19458364 BACKGROUND

• 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.

  PMID: 26084116 BACKGROUND

• 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.

  PMID: 23749750 BACKGROUND

• 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.

  PMID: 16247707 BACKGROUND

• 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.

  PMID: 25175122 BACKGROUND

MeSH Terms

Interventions

beraprost

Central Study Contacts

Jung Tak Park, M.D., Ph.D.

CONTACT

82-2-2228-2281; jtpark@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment group is randomly assigned to start taking 120 mcg of Berasil. On the other hand, the control group does not take anything.

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 5, 2017
• Study Start: April 5, 2017
• Primary Completion: April 4, 2019
• Study Completion: April 4, 2019
• Last Updated: May 18, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)