Beraprost Sodium and Arterial Stiffness in Patients With Type 2 Diabetic Nephropathy
NCT ID: NCT01796418
Last Updated: 2013-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
102 participants
INTERVENTIONAL
2013-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Beraprost sodium
Beraprost sodium 0.02 mg capsule by mouth every 12 hours for 12 weeks
Beraprost sodium
Placebo
Placebo capsule by mouth every 12 hours for 12 weeks
No interventions assigned to this group
Interventions
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Beraprost sodium
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
75 Years
ALL
No
Sponsors
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Astellas Pharma Korea, Inc.
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Dong Ki Kim
Professor
Principal Investigators
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Chun-Soo Lim, Prof
Role: STUDY_CHAIR
Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Korea
Dong Ki Kim, Prof
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea
Ki Young Na, Prof
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
Sung Gyun Kim, Prof
Role: PRINCIPAL_INVESTIGATOR
Hallym University Medical Center
Young-Ki Lee, Prof
Role: PRINCIPAL_INVESTIGATOR
Hallym University Kangnam Sacred Heart Hospital
Locations
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Hallym University Sacred Heart Hospital
Anyang, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Kangnam Sacred Heart Hospital
Seoul, , South Korea
Seoul National University Boramae Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Sung Gyun Kim, Prof
Role: primary
Ki Young Na, Prof
Role: primary
Young-Ki Lee, Prof
Role: primary
Chun-Soo Lim, Prof
Role: primary
Dong Ki Kim, Prof
Role: primary
References
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Schiffrin EL, Lipman ML, Mann JF. Chronic kidney disease: effects on the cardiovascular system. Circulation. 2007 Jul 3;116(1):85-97. doi: 10.1161/CIRCULATIONAHA.106.678342.
Foley RN, Murray AM, Li S, Herzog CA, McBean AM, Eggers PW, Collins AJ. Chronic kidney disease and the risk for cardiovascular disease, renal replacement, and death in the United States Medicare population, 1998 to 1999. J Am Soc Nephrol. 2005 Feb;16(2):489-95. doi: 10.1681/ASN.2004030203. Epub 2004 Dec 8.
Melian EB, Goa KL. Beraprost: a review of its pharmacology and therapeutic efficacy in the treatment of peripheral arterial disease and pulmonary arterial hypertension. Drugs. 2002;62(1):107-33. doi: 10.2165/00003495-200262010-00005.
Sugawara A, Kudo M, Saito A, Matsuda K, Uruno A, Ito S. Novel effects of beraprost sodium on vasculatures. Int Angiol. 2010 Apr;29(2 Suppl):28-32.
Goya K, Otsuki M, Xu X, Kasayama S. Effects of the prostaglandin I2 analogue, beraprost sodium, on vascular cell adhesion molecule-1 expression in human vascular endothelial cells and circulating vascular cell adhesion molecule-1 level in patients with type 2 diabetes mellitus. Metabolism. 2003 Feb;52(2):192-8. doi: 10.1053/meta.2003.50025.
Nakayama T, Hironaga T, Ishima H, Maruyama T, Masubuchi Y, Kokubun S. The prostacyclin analogue beraprost sodium prevents development of arterial stiffness in elderly patients with cerebral infarction. Prostaglandins Leukot Essent Fatty Acids. 2004 Jun;70(6):491-4. doi: 10.1016/j.plefa.2003.10.004.
Nakayama T, Masubuchi Y, Kawauchi K, Masaki R, Hironaga T, Ishima H, Torigoe M, Shimabukuro H. Beneficial effect of beraprost sodium plus telmisartan in the prevention of arterial stiffness development in elderly patients with hypertension and cerebral infarction. Prostaglandins Leukot Essent Fatty Acids. 2007 Jun;76(6):309-14. doi: 10.1016/j.plefa.2007.05.004. Epub 2007 Jul 9.
Watanabe M, Nakashima H, Ito K, Miyake K, Saito T. Improvement of dyslipidemia in OLETF rats by the prostaglandin I(2) analog beraprost sodium. Prostaglandins Other Lipid Mediat. 2010 Sep;93(1-2):14-9. doi: 10.1016/j.prostaglandins.2010.04.003. Epub 2010 May 5.
Sato N, Kaneko M, Tamura M, Kurumatani H. The prostacyclin analog beraprost sodium ameliorates characteristics of metabolic syndrome in obese Zucker (fatty) rats. Diabetes. 2010 Apr;59(4):1092-100. doi: 10.2337/db09-1432. Epub 2010 Jan 12.
Rubin MF, Rosas SE, Chirinos JA, Townsend RR. Surrogate markers of cardiovascular disease in CKD: what's under the hood? Am J Kidney Dis. 2011 Mar;57(3):488-97. doi: 10.1053/j.ajkd.2010.08.030. Epub 2010 Dec 18.
Levey AS, Coresh J, Greene T, Stevens LA, Zhang YL, Hendriksen S, Kusek JW, Van Lente F; Chronic Kidney Disease Epidemiology Collaboration. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med. 2006 Aug 15;145(4):247-54. doi: 10.7326/0003-4819-145-4-200608150-00004.
Noordzij M, Tripepi G, Dekker FW, Zoccali C, Tanck MW, Jager KJ. Sample size calculations: basic principles and common pitfalls. Nephrol Dial Transplant. 2010 May;25(5):1388-93. doi: 10.1093/ndt/gfp732. Epub 2010 Jan 12.
Na KY, Kim DK, Kim SG, Lee YK, Lim CS. Effect of beraprost sodium on arterial stiffness in patients with type 2 diabetic nephropathy. Trials. 2013 Sep 2;14:275. doi: 10.1186/1745-6215-14-275.
Other Identifiers
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BESTinDN-001
Identifier Type: -
Identifier Source: org_study_id