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
  Purpose

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.


Condition Intervention
Diabetic Nephropathy
Drug: Beraprost sodium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Beraprost Sodium on Arterial Stiffness in Patients With Type 2 Diabetic Nephropathy (BESTinDN Study)

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 102
Study Start Date: March 2013
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Beraprost sodium
Beraprost sodium 0.02 mg capsule by mouth every 12 hours for 12 weeks
Drug: Beraprost sodium
Other Name: Berasil
Placebo Comparator: Placebo
Placebo capsule by mouth every 12 hours for 12 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796418

Contacts
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

Locations
Korea, Republic of
Hallym University Sacred Heart Hospital Recruiting
Anyang, Korea, Republic of
Contact: Sung Gyun Kim, Prof    82-31-380-3728    sgkim@hallym.ac.kr   
Principal Investigator: Sung Gyun Kim, Prof         
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of
Contact: Ki Young Na, Prof       kyna@snubh.org   
Principal Investigator: Ki Young Na, Prof         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Dong Ki Kim, Prof    82-2-2072-2303    dkkim73@gmail.com   
Principal Investigator: Dong Ki Kim, Prof         
Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Chun-Soo Lim, Prof    82-2-872-2120    cslimjy@snu.ac.kr   
Principal Investigator: Chun-Soo Lim, Prof         
Kangnam Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of
Contact: Young-Ki Lee, Prof    82-2-829-5114    km2071@naver.com   
Principal Investigator: Young-Ki Lee, Prof         
Sponsors and Collaborators
Seoul National University Hospital
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 Kangnam Sacred Heart Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dong Ki Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01796418     History of Changes
Other Study ID Numbers: BESTinDN-001
Study First Received: February 19, 2013
Last Updated: December 13, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Beraprost
Epoprostenol
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on September 18, 2014