Status:

UNKNOWN

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

Lead Sponsor:

Seoul National University Hospital

Collaborating Sponsors:

Astellas Pharma Korea, Inc.

Conditions:

Diabetic Nephropathy

Eligibility:

All Genders

20-75 years

Phase:

NA

Brief Summary

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 additi...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

102 Patients enrolled

Trial Details

Trial ID

NCT01796418

Start Date

March 1 2013

Last Update

December 16 2013

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Hallym University Sacred Heart Hospital

Anyang, South Korea

2

Seoul National University Bundang Hospital

Seongnam, South Korea

3

Kangnam Sacred Heart Hospital

Seoul, South Korea

4

Seoul National University Boramae Medical Center

Seoul, South Korea