Effect of Sulodexide on Albuminuria in Chinese Type 2 Diabetic Patients

NCT01316068 | Unknown Phase 4 DMC

• 1 other identifier: sulodexide20110311
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Current therapies targeting albuminuria in diabetic nephropathy leave residual urinary albumin secretion, which meanwhile leave residual cardiovascular risk. Previous studies demonstrated that sulodexide could reduce albuminuria in type 2 diabetic patients. But no data concerning Chinese population is available. The investigators aim to provide evidence of effects of sulodexide on diabetic nephropathy in Chinese diabetic patients. Further the investigators also test the hypothesis that sequential administration of intravenous and oral replacement of the drug would gain an earlier and greater reduction of albuminuria, compared with oral use only.

Conditions

Diabetic Nephropathy; Albuminuria

Keywords

diabetic nephropathy; albuminuria; type 2 diabetes; sulodexide

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in urine albumin/creatinine ratio

  conversion to normoalbuminuria and at least a 25% reduction in UACR opposed to baseline, or 50% reduction in UACR opposed to baseline

  52th week since the commence of therapy

Secondary Outcomes (1)

• Change from Baseline in urine albumin/creatinine ratio and serum creatinine

  before and 2nd,12th,24th,36th and 60th week since the commence of therapy

Study Arms (2)

sequencial use of sulodexide

EXPERIMENTAL

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.

Drug: intravenous use of sulodexide followed by oral use

oral use of sulodexide

ACTIVE COMPARATOR

Patients allocated to oral group will received 1000 LSU per day orally for 52 weeks

Drug: use of sulodexide orally only

Interventions

intravenous use of sulodexide followed by oral use DRUG

Patients will be given sulodexide 1200 LSU per day intravenously for 2 weeks,then receive 1000 LSU per day orally for 50 weeks.

Also known as: sequential use of sulodexide

sequencial use of sulodexide

use of sulodexide orally only DRUG

Patients receive 1000 LSU per day orally for 52 weeks

Also known as: oral use of sulodexide

oral use of sulodexide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 2 diabetes based on WHO 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

You may not qualify if:

• Type 1 diabetes mellitus
• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• ALFA WASSERMANN（BJ) Market Research and Management Co., Ltd: collaborator

Study Sites (1)

endocrinology department of the first affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (9)

• 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.

  PMID: 20175052 BACKGROUND

• 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.

  PMID: 20037813 BACKGROUND

• 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.

  PMID: 20061322 BACKGROUND

• 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.

  PMID: 18227486 BACKGROUND

• 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.

  PMID: 18062718 BACKGROUND

• 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.

  PMID: 17191008 BACKGROUND

• 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.

  PMID: 16299683 BACKGROUND

• 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.

  PMID: 12039991 BACKGROUND

• 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.

  PMID: 9483374 BACKGROUND

MeSH Terms

Conditions

Diabetic Nephropathies; Albuminuria; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Yanbing Li, PhD

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: March 16, 2011
• Study Start: March 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 16, 2011

Record last verified: 2010-08

Locations

CN (1)