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Arteriovenous Fistula PatencyNCT03142360

Effect of Beraprost Sodium (Berasil) on Hemodialysis

A study testing Beraprost sodium (Berasil) in people with Arteriovenous Fistula Patency, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 to 79 years
Conditions the study is for
Arteriovenous Fistula Patency
What is being tested?
Beraprost sodium (Berasil)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSouth Korea
Study dates
5 Apr 2017to 4 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

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

82-2-2228-2281

jtpark@yuhs.ac

South Korea1 site, 1 recruiting

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

    Seoul, 120-752

    Jung Tak Park, M.D., Ph,D, 82-2-2228-2281, jtpark@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

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.

Read more

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.

Read the 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.

Being tested
Beraprost sodium (Berasil)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03142360
Study groupRoleWhat they receive
Treatment groupExperimentalWithin two days after successful arteriovenous graft surgery, the treatment group is randomly assigned to start taking 120 mcg of Berasil.
Receives: Drug: Beraprost sodium (Berasil)
Non-Treatment groupNo interventionOn the other hand, the control group does not take anything.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months after arteriovenous graft surgery

Secondary outcomes (4)

  1. 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

    Measured: 1 month after arteriovenous graft surgery

  2. Hemodialysis performed rate

    Measured: 3 months after arteriovenous graft surgery

  3. AVF failure rate

    Measured: 6 months after arteriovenous graft surgery

  4. Bleeding events

    Measured: 6 months after arteriovenous graft surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2017
  2. Study start5 Apr 2017
  3. Primary completion4 Apr 2019 (estimated)
  4. Study completion4 Apr 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03142360
Sponsor's protocol ID
4-2017-0129
Status last verified
May 2018
First submitted
3 May 2017
Last updated
18 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23474008

  • 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.

    PubMed 24066672

  • 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.

    PubMed 19458364

  • 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.

    PubMed 26084116

  • 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.

    PubMed 23749750

  • 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.

    PubMed 16247707

  • 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.

    PubMed 25175122

Questions about this trial

What is this clinical trial studying?

A study testing Beraprost sodium (Berasil) in people with Arteriovenous Fistula Patency, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jung Tak Park, M.D., Ph.D. (82-2-2228-2281, jtpark@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AVF maturation rate (time frame: 3 months after arteriovenous graft surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03142360, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.

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