Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Beraprost Sodium (Berasil) on Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03142360
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.


Condition or disease Intervention/treatment Phase
Arteriovenous Fistula Patency Drug: Beraprost sodium (Berasil) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Effect of Beraprost Sodium (Berasil) on Hemodialysis
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : April 4, 2019
Estimated Study Completion Date : April 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Fistulas

Arm Intervention/treatment
Experimental: Treatment group
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)
Within two days after successful arteriovenous graft surgery, the treatment group is randomly assigned to start taking 120 mcg of Berasil.

No Intervention: Non-Treatment group
On the other hand, the control group does not take anything.



Primary Outcome Measures :
  1. AVF maturation rate [ Time Frame: 3 months after arteriovenous graft surgery ]
    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 :
  1. AVF maturation rate [ Time Frame: 1 month after arteriovenous graft surgery ]
    Physiologic maturation of the AVF by the definition of AVF access blood flow ≥500mlL/min and AVF diameter ≥4mm at a month

  2. Hemodialysis performed rate [ Time Frame: 3 months after arteriovenous graft surgery ]
  3. AVF failure rate [ Time Frame: 6 months after arteriovenous graft surgery ]
  4. Bleeding events [ Time Frame: 6 months after arteriovenous graft surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142360


Contacts
Layout table for location contacts
Contact: Jung Tak Park, M.D., Ph.D. 82-2-2228-2281 jtpark@yuhs.ac

Locations
Layout table for location information
Korea, Republic of
Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jung Tak Park, M.D., Ph,D    82-2-2228-2281    jtpark@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Publications:

Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03142360     History of Changes
Other Study ID Numbers: 4-2017-0129
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Platelet Aggregation Inhibitors
Fistula
Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Beraprost
Epoprostenol
Vasodilator Agents
Antihypertensive Agents