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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Seoul National University Hospital
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Dong Ki Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01796418
First received: February 19, 2013
Last updated: December 13, 2013
Last verified: December 2013

February 19, 2013
December 13, 2013
March 2013
August 2014   (final data collection date for primary outcome measure)
Brachial ankle pulse wave velocity (PWV) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The change of brachial ankle PWV at 12 weeks compared to baseline (0 week)
Same as current
Complete list of historical versions of study NCT01796418 on ClinicalTrials.gov Archive Site
  • Ankle brachial indices (ABI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The change of ABI at 12 weeks compared to baseline (0 week)
  • Urine albumin creatinine ratio (UACR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The change of UACR at 12 weeks compared to baseline (0 week)
  • IDMS MDRD estimated glomerular filtration rate (eGFR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The change of IDMS MDRD eGFR at 12 weeks compared to baseline (0 week)
  • Lipid profiles [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The change of total cholesterol, LDL-cholesterol, and triglyceride at 12 weeks compared to baseline (0 week)
  • Blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The change of systolic and diastolic blood pressure at 12 weeks compared to baseline (0 week)
Same as current
Not Provided
Not Provided
 
Beraprost Sodium and Arterial Stiffness in Patients With Type 2 Diabetic Nephropathy
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Nephropathy
Drug: Beraprost sodium
Other Name: Berasil
  • Experimental: Beraprost sodium
    Beraprost sodium 0.02 mg capsule by mouth every 12 hours for 12 weeks
    Intervention: Drug: Beraprost sodium
  • Placebo Comparator: Placebo
    Placebo capsule by mouth every 12 hours for 12 weeks

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
102
Not Provided
August 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact: Chun-Soo Lim, Prof 82-2-870-2120 cslimjy@snu.ac.kr
Contact: Dong Ki Kim, Prof 82-2-2072-2303 dkkim73@gmail.com
Korea, Republic of
 
NCT01796418
BESTinDN-001
No
Dong Ki Kim, Seoul National University Hospital
Seoul National University Hospital
Astellas Pharma Korea, Inc.
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 Kangnam Sacred Heart Hospital
Seoul National University Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP