Effect of Sulodexide on Albuminuria in Chinese Type 2 Diabetic Patients
NCT ID: NCT01316068
Last Updated: 2011-03-16
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
PHASE4
80 participants
INTERVENTIONAL
2011-03-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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sequencial use of sulodexide
Patients will be given sulodexide 1200 LSU per day intravenously for 2 weeks. Then patients will receive 1000 LSU per day orally for 50 weeks.
intravenous use of sulodexide followed by oral use
Patients will be given sulodexide 1200 LSU per day intravenously for 2 weeks,then receive 1000 LSU per day orally for 50 weeks.
oral use of sulodexide
Patients allocated to oral group will received 1000 LSU per day orally for 52 weeks
use of sulodexide orally only
Patients receive 1000 LSU per day orally for 52 weeks
Interventions
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intravenous use of sulodexide followed by oral use
Patients will be given sulodexide 1200 LSU per day intravenously for 2 weeks,then receive 1000 LSU per day orally for 50 weeks.
use of sulodexide orally only
Patients receive 1000 LSU per day orally for 52 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-75 years old
* Serum creatinine ≤ 1.5 mg/dL (130umol/L)
* Albuminuria defined by a urine albumin/creatinine ratio(ACR) according to ADA criteria 2009 (microalbuminuria by 30-299 ug albumin/mg creatinine and macroalbuminuria by ≥300 ug albumin/mg creatinine on random spot urine collection )
* Continued stable seated systolic blood pressure \< 180 mmHg and diastolic blood pressure \< 110 mmHg
* Willing to change antihypertensive medication regimen if necessary
* Willing to provide written informed consent to participate in the study
* Willing to take contraception,or infertility for the duration of the study
Exclusion Criteria
* Present acute diabetic complication, or severe chronic diabetic complication(e.g. proliferative diabetic retinopathy)
* Complicating uncontrolled severe infection
* Hepatic insufficiency or renal insufficiency or severe disturbance of lipid metabolism
* Blood pressure ≥ 180/110mmHg
* Severe concomitant systemic disease(e.g. cardiac insufficiency, stroke), anticipated to be unable to finish the trial
* Uncooperative,unable to follow up, or anticipated unable to finish the trial
* Patients with other known specific renal diseases
* Untreated urinary tract infection that would impact urinary protein values
* Evidence of hepatic dysfunction including total bilirubin \> 2.0 mg/dL (34 mmol/L) or elevated transaminases
* History of Cardiovascular disease as follows: Unstable angina pectoris, myocardial infarction, transient ischemic attack, cerebrovascular accident, New York Heart Association Functional Class III or IV heart failure, obstructive valvular heart disease or hypertrophic cardiomyopathy
* Any risk of bleeding, or platelet count \< 100×109/L or anticipated surgery within research period
* Active, recurrent or metastatic cancer, or known HIV infection
* Participant in any experimental drug study in the past 90 days prior to the enrollment of the study, or plan to participate in any drug study during the study period
* Prior exposure to sulodexide, either in a clinical setting or as a participant in another clinical study
* Known allergy or intolerance to any heparin-like compounds or multiple drug allergies
* Lactation, pregnancy, or an anticipated or planned pregnancy during the study period
* Inability to give an informed consent or to cooperate with researchers (e.g. psychiatric disorder) or history of noncompliance to medical regimen
18 Years
75 Years
ALL
No
Sponsors
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ALFA WASSERMANN（BJ) Market Research and Management Co., Ltd
UNKNOWN
Sun Yat-sen University
OTHER
Responsible Party
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Yanbing Li
Principal Investigators
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Yanbing Li, PhD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Sun Yat-Sen University
Locations
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endocrinology department of the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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References
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Blouza S, Dakhli S, Abid H, Aissaoui M, Ardhaoui I, Ben Abdallah N, Ben Brahim S, Ben Ghorbel I, Ben Salem N, Beji S, Chamakhi S, Derbel A, Derouiche F, Djait F, Doghri T, Fourti Y, Gharbi F, Jellouli K, Jellazi N, Kamoun K, Khedher A, Letaief A, Limam R, Mekaouer A, Miledi R, Nagati K, Naouar M, Sellem S, Tarzi H, Turki S, Zidi B, Achour A; DAVET (Diabetic Albuminuria Vessel Tunisia Study Investigators). Efficacy of low-dose oral sulodexide in the management of diabetic nephropathy. J Nephrol. 2010 Jul-Aug;23(4):415-24.
Chen S, Fang Z, Zhu Z, Deng A, Liu J, Zhang C. Protective effect of sulodexide on podocyte injury in adriamycin nephropathy rats. J Huazhong Univ Sci Technolog Med Sci. 2009 Dec;29(6):715-9. doi: 10.1007/s11596-009-0608-0. Epub 2009 Dec 29.
Rossini M, Naito T, Yang H, Freeman M, Donnert E, Ma LJ, Dunn SR, Sharma K, Fogo AB. Sulodexide ameliorates early but not late kidney disease in models of radiation nephropathy and diabetic nephropathy. Nephrol Dial Transplant. 2010 Jun;25(6):1803-10. doi: 10.1093/ndt/gfp724. Epub 2010 Jan 7.
Lewis EJ, Xu X. Abnormal glomerular permeability characteristics in diabetic nephropathy: implications for the therapeutic use of low-molecular weight heparin. Diabetes Care. 2008 Feb;31 Suppl 2:S202-7. doi: 10.2337/dc08-s251.
Weiss R, Niecestro R, Raz I. The role of sulodexide in the treatment of diabetic nephropathy. Drugs. 2007;67(18):2681-96. doi: 10.2165/00003495-200767180-00004.
Sulikowska B, Olejniczak H, Muszynska M, Odrowaz-Sypniewska G, Gaddi A, Savini C, Cicero AF, Laghi L, Manitius J. Effect of sulodexide on albuminuria, NAG excretion and glomerular filtration response to dopamine in diabetic patients. Am J Nephrol. 2006;26(6):621-8. doi: 10.1159/000098195. Epub 2006 Dec 21.
Achour A, Kacem M, Dibej K, Skhiri H, Bouraoui S, El May M. One year course of oral sulodexide in the management of diabetic nephropathy. J Nephrol. 2005 Sep-Oct;18(5):568-74.
Gambaro G, Kinalska I, Oksa A, Pont'uch P, Hertlova M, Olsovsky J, Manitius J, Fedele D, Czekalski S, Perusicova J, Skrha J, Taton J, Grzeszczak W, Crepaldi G. Oral sulodexide reduces albuminuria in microalbuminuric and macroalbuminuric type 1 and type 2 diabetic patients: the Di.N.A.S. randomized trial. J Am Soc Nephrol. 2002 Jun;13(6):1615-25. doi: 10.1097/01.asn.0000014254.87188.e5.
Poplawska A, Szelachowska M, Topolska J, Wysocka-Solowie B, Kinalska I. Effect of glycosaminoglycans on urinary albumin excretion in insulin-dependent diabetic patients with micro- or macroalbuminuria. Diabetes Res Clin Pract. 1997 Nov;38(2):109-14. doi: 10.1016/s0168-8227(97)00096-x.
Other Identifiers
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sulodexide20110311
Identifier Type: -
Identifier Source: org_study_id
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