Diabetic NephropathyNCT01796418
Beraprost Sodium and Arterial Stiffness in Patients With Type 2 Diabetic Nephropathy
A study testing Beraprost sodium in people with Diabetic Nephropathy, run by Seoul National University Hospital at 5 sites in South Korea.
Trial 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 addition, cardiovascular complication has been the most common cause of death in these patients. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- Beraprost sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Mar 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Anyang
Sung Gyun Kim, Prof, 82-31-380-3728, sgkim@hallym.ac.kr
Sung Gyun Kim, Prof
- Recruiting
Seoul National University Bundang Hospital
Seongnam
Ki Young Na, Prof, kyna@snubh.org
Ki Young Na, Prof
- Recruiting
Kangnam Sacred Heart Hospital
Seoul
Young-Ki Lee, Prof, 82-2-829-5114, km2071@naver.com
Young-Ki Lee, Prof
- Recruiting
Seoul National University Boramae Medical Center
Seoul
Chun-Soo Lim, Prof, 82-2-872-2120, cslimjy@snu.ac.kr
Chun-Soo Lim, Prof
- Recruiting
Seoul National University Hospital
Seoul
Dong Ki Kim, Prof, 82-2-2072-2303, dkkim73@gmail.com
Dong Ki Kim, Prof
About this study
Official title: 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.
- Conditions
- Diabetic Nephropathy
- Being tested
- Beraprost sodium
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beraprost sodiumDrug
Also called Berasil
| Study group | Role | What they receive |
|---|---|---|
| Beraprost sodium | Experimental | Beraprost sodium 0.02 mg capsule by mouth every 12 hours for 12 weeks Receives: Drug: Beraprost sodium |
| Placebo | Placebo comparator | Placebo capsule by mouth every 12 hours for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial ankle pulse wave velocity (PWV)
The change of brachial ankle PWV at 12 weeks compared to baseline (0 week)
Measured: 12 weeks
Secondary outcomes (5)
Ankle brachial indices (ABI)
The change of ABI at 12 weeks compared to baseline (0 week)
Measured: 12 weeks
Urine albumin creatinine ratio (UACR)
The change of UACR at 12 weeks compared to baseline (0 week)
Measured: 12 weeks
IDMS MDRD estimated glomerular filtration rate (eGFR)
The change of IDMS MDRD eGFR at 12 weeks compared to baseline (0 week)
Measured: 12 weeks
Lipid profiles
The change of total cholesterol, LDL-cholesterol, and triglyceride at 12 weeks compared to baseline (0 week)
Measured: 12 weeks
Blood pressure
The change of systolic and diastolic blood pressure at 12 weeks compared to baseline (0 week)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Korea, Inc.
- Responsible party
- Principal investigator, Dong Ki Kim, Seoul National University Hospital
- Investigators
- Chun-Soo Lim, Prof, Study chair, Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, KoreaDong Ki Kim, Prof, Principal investigator, Department of Internal Medicine, Seoul National University Hospital, Seoul, KoreaKi Young Na, Prof, Principal investigator, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, KoreaSung Gyun Kim, Prof, Principal investigator, Hallym University Medical CenterYoung-Ki Lee, Prof, Principal investigator, Hallym University Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796418
- Sponsor's protocol ID
- BESTinDN-001
- Status last verified
- Dec 2013
- First submitted
- 19 Feb 2013
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17606856Foley 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.
PubMed 15590763Melian 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.
PubMed 11790158Sugawara 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.
PubMed 20357746Goya 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.
PubMed 12601631Nakayama 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.
PubMed 15120711Nakayama 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.
PubMed 17616452Watanabe 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.
PubMed 20450981Sato 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.
PubMed 20068136Rubin 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.
PubMed 21168944Levey 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.
PubMed 16908915Noordzij 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.
PubMed 20067907Na 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.
PubMed 24066672
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Beraprost Sodium on Arterial Stiffness in Patients With Type 2 Diabetic Nephropathy (BESTinDN Study)
- ClinicalTrials.gov ID
- NCT01796418
- Acronym / sponsor ID
- BESTinDN-001
- Conditions
- Diabetic Nephropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Astellas Pharma Korea, Inc.
- Study start
- Mar 2013
- Primary completion
- Aug 2014 (estimated)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beraprost sodium | Experimental | Drug: Beraprost sodiumBeraprost sodium 0.02 mg capsule by mouth every 12 hours for 12 weeks |
| Placebo | Placebo comparator | –Placebo capsule by mouth every 12 hours for 12 weeks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beraprost sodiumAlso: Berasil | Drug | Beraprost sodium |
Primary outcome
Brachial ankle pulse wave velocity (PWV)
Time frame: 12 weeks
The change of brachial ankle PWV at 12 weeks compared to baseline (0 week)
5 secondary outcomes
Ankle brachial indices (ABI)
Time frame: 12 weeks
Urine albumin creatinine ratio (UACR)
Time frame: 12 weeks
IDMS MDRD estimated glomerular filtration rate (eGFR)
Time frame: 12 weeks
Lipid profiles
Time frame: 12 weeks
Blood pressure
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
- Background: PubMed 17606856Schiffrin 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.
- Background: PubMed 15590763Foley 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.
- Background: PubMed 11790158Melian 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.
- Background: PubMed 20357746Sugawara 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.
- Background: PubMed 12601631Goya 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.
- Background: PubMed 15120711Nakayama 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.
- Background: PubMed 17616452Nakayama 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.
- Background: PubMed 20450981Watanabe 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.
- Background: PubMed 20068136Sato 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.
- Background: PubMed 21168944Rubin 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.
- Background: PubMed 16908915Levey 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.
- Background: PubMed 20067907Noordzij 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Soo Lim, Prof study chair
Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Korea
Dong Ki Kim, Prof principal investigator
Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea
Ki Young Na, Prof principal investigator
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beraprost sodium in people with Diabetic Nephropathy, run by Seoul National University Hospital at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Soo Lim, Prof (82-2-870-2120, cslimjy@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial ankle pulse wave velocity (PWV) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01796418, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2013.