Beraprost Sodium and Arterial Stiffness in Patients With Type 2 Diabetic Nephropathy

December 13, 2013 updated by: Dong Ki Kim, Seoul National University Hospital

Effect of Beraprost Sodium on Arterial Stiffness in Patients With Type 2 Diabetic Nephropathy (BESTinDN Study)

Diabetic nephropathy, the leading cause of end-stage renal disease in many countries, is characterized by high cardiovascular mortality and morbidity even in the early course of the disease. In addition, cardiovascular complication has been the most common cause of death in these patients. Thus, early detection and appropriate intervention for this highly common and critical complication is considered to play an important role in the management of the disease. In this regard, much interest has been focused on the early markers which can predict arterial diseases before the clinically apparent cardiovascular diseases. Recently, glowing evidence suggests that arterial stiffness as assessed by pulse wave velocity (PWV) may serve as a surrogate marker for future cardiovascular disease. In fact, increased PWV has been known to be independently associated with diabetic nephropathy in type 2 diabetes.

Beraprost sodium (BPS) is a stable orally active prostacyclin (PGI2) analogue that has a potent vasodilatory and anti-platelet effect. Also, BPS has been suggested to improve a micro-vascular circulation through a reduction of red blood cell deformability. In addition, recent studies have demonstrated that BPS improves endothelial function through an increase in endothelial nitric oxide synthesis and NO synthase gene transcription. These beneficial effects of BPS have been known to reduce PWV in patients prone to cardiovascular diseases such as elderly, hypertension, or a history of cerebral infarction. However, the effect of BPS on arterial stiffness in patients with diabetic nephropathy remains elusive. Our study will address the effect of BPS on arterial stiffness by PWV in patients with diabetic nephropathy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of
        • Recruiting
        • Hallym University Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Sung Gyun Kim, Prof
      • Seongnam, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Ki Young Na, Prof
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Dong Ki Kim, Prof
      • Seoul, Korea, Republic of
        • Recruiting
        • KangNam Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Young-Ki Lee, Prof
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Boramae Medical Center
        • Contact:
        • Principal Investigator:
          • Chun-Soo Lim, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 19 years or more and 75 years or less
  • Type 2 diabetes who is prescribed glucose-lowering agent or insulin
  • Estimated glomerular filtration rate (GFR) by isotope dilution mass spectrometry (IDMS)- Modification of Diet in Renal Disease (MDRD) equation 30 ml/min/1.73 m2 or more
  • verified 2 times or more of albuminuria 30 mg/g cr (or protein 300 mg/g cr)or more in a spot urine sample with interval of 1 week or more in recent 6 months
  • Patients whose blood pressure is 140/90 mmHg or less and did not receive a prescription for additional antihypertensive medication in recent 3 months
  • Patients who give written consent to this study by oneself

Exclusion Criteria:

  • History of kidney transplantation
  • current advanced congestive heart failure (NYHA class III or more)
  • current uncontrolled arrhythmia
  • current advanced liver cirrhosis (Child-Pugh class C)
  • History of bleeding diathesis
  • current active infection or uncontrolled inflammatory disorders
  • History of cerebrovascular accident or myocardial infarction
  • current use of anticoagulant
  • current use of two or more antiplatelet agents
  • patients with advanced malignancy (life expectancy less than 6 months)
  • patients with uncontrolled diabetes (Hba1c more than 10%)
  • patients with severe anemia (Hb less than 8.0 g/dL)
  • female who are pregnant, trying to get pregnant or lactating
  • Genetic diseases such as galactose intolerance, lactose deficiency or glucose-galactose malabsorption

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Beraprost sodium
Beraprost sodium 0.02 mg capsule by mouth every 12 hours for 12 weeks
Drug: Beraprost sodium
Other Names:
  • Berasil
Placebo Comparator: Placebo
Placebo capsule by mouth every 12 hours for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brachial ankle pulse wave velocity (PWV)
Time Frame: 12 weeks
The change of brachial ankle PWV at 12 weeks compared to baseline (0 week)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle brachial indices (ABI)
Time Frame: 12 weeks
The change of ABI at 12 weeks compared to baseline (0 week)
12 weeks
Urine albumin creatinine ratio (UACR)
Time Frame: 12 weeks
The change of UACR at 12 weeks compared to baseline (0 week)
12 weeks
IDMS MDRD estimated glomerular filtration rate (eGFR)
Time Frame: 12 weeks
The change of IDMS MDRD eGFR at 12 weeks compared to baseline (0 week)
12 weeks
Lipid profiles
Time Frame: 12 weeks
The change of total cholesterol, LDL-cholesterol, and triglyceride at 12 weeks compared to baseline (0 week)
12 weeks
Blood pressure
Time Frame: 12 weeks
The change of systolic and diastolic blood pressure at 12 weeks compared to baseline (0 week)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Astellas Pharma Korea, Inc.

Investigators

  • Study Chair: Chun-Soo Lim, Prof, Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Korea
  • Principal Investigator: Dong Ki Kim, Prof, Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea
  • Principal Investigator: Ki Young Na, Prof, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
  • Principal Investigator: Sung Gyun Kim, Prof, Hallym University Medical Center
  • Principal Investigator: Young-Ki Lee, Prof, Hallym University Kangnam Sacred Heart Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

February 19, 2013

First Posted (Estimate)

February 21, 2013

Study Record Updates

Last Update Posted (Estimate)

December 16, 2013

Last Update Submitted That Met QC Criteria

December 13, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BESTinDN-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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