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Diabetic NephropathyPhase 4SoftenNCT01316068

Effect of Sulodexide on Albuminuria in Chinese Type 2 Diabetic Patients

A Phase 4 study testing intravenous use of sulodexide followed by oral use and use of sulodexide orally only in people with Diabetic Nephropathy and Albuminuria, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetic Nephropathy, Albuminuria
What is being tested?
intravenous use of sulodexide followed by oral use and use of sulodexide orally only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
Mar 2011to Aug 2012
Phase
Phase 4
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: Effect of Intravenous and Oral Therapy With Sulodexide on Albuminuria in Type 2 Diabetic Patients

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.

Being tested
intravenous use of sulodexide followed by oral use, use of sulodexide orally only
Keywords
diabetic nephropathy, albuminuria, type 2 diabetes, sulodexide
Medical subject headings
Diabetic Nephropathies, Albuminuria, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intravenous use of sulodexide followed by oral useDrug

    Also called sequential use of sulodexide

    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 onlyDrug

    Also called oral use of sulodexide

    Patients receive 1000 LSU per day orally for 52 weeks

Study groups in NCT01316068
Study groupRoleWhat they receive
sequencial use of sulodexideExperimentalPatients will be given sulodexide 1200 LSU per day intravenously for 2 weeks. Then patients will receive 1000 LSU per day orally for 50 weeks.
Receives: Drug: intravenous use of sulodexide followed by oral use
oral use of sulodexideActive comparatorPatients allocated to oral group will received 1000 LSU per day orally for 52 weeks
Receives: Drug: use of sulodexide orally only

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 52th week since the commence of therapy

Secondary outcomes (1)

  1. Change from Baseline in urine albumin/creatinine ratio and serum creatinine

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionAug 2012 (estimated)
  4. Study completionAug 2012 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01316068
Sponsor's protocol ID
sulodexide20110311
Acronym
Soften
Status last verified
Aug 2010
First submitted
15 Mar 2011
Last updated
16 Mar 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20175052

  • 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.

    PubMed 20037813

  • 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.

    PubMed 20061322

  • 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.

    PubMed 18227486

  • 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.

    PubMed 18062718

  • 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.

    PubMed 17191008

  • 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.

    PubMed 16299683

  • 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.

    PubMed 12039991

  • 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.

    PubMed 9483374

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing intravenous use of sulodexide followed by oral use and use of sulodexide orally only in people with Diabetic Nephropathy and Albuminuria, run by Sun Yat-sen University at 1 site in China.

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 8 inclusion and 18 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 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in urine albumin/creatinine ratio (time frame: 52th week since the commence of therapy). 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 NCT01316068, which also lists 9 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 Mar 2011.

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