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Effect of Sulodexide on Albuminuria in Chinese Type 2 Diabetic Patients (Soften)

Primary Purpose

Diabetic Nephropathy, Albuminuria

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
intravenous use of sulodexide followed by oral use
use of sulodexide orally only
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring diabetic nephropathy, albuminuria, type 2 diabetes, sulodexide

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sequencial use of sulodexide

oral use of sulodexide

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 15, 2011
Last Updated
March 15, 2011
Sponsor
Sun Yat-sen University
Collaborators
ALFA WASSERMANN（BJ) Market Research and Management Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01316068
Brief Title
Effect of Sulodexide on Albuminuria in Chinese Type 2 Diabetic Patients
Acronym
Soften
Official Title
Effect of Intravenous and Oral Therapy With Sulodexide on Albuminuria in Type 2 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University
Collaborators
ALFA WASSERMANN（BJ) Market Research and Management Co., Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy, Albuminuria
Keywords
diabetic nephropathy, albuminuria, type 2 diabetes, sulodexide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sequencial use of sulodexide
Arm Type
Experimental
Arm Description
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.
Arm Title
oral use of sulodexide
Arm Type
Active Comparator
Arm Description
Patients allocated to oral group will received 1000 LSU per day orally for 52 weeks
Intervention Type
Drug
Intervention Name(s)
intravenous use of sulodexide followed by oral use
Other Intervention Name(s)
sequential use of sulodexide
Intervention Description
Patients will be given sulodexide 1200 LSU per day intravenously for 2 weeks,then receive 1000 LSU per day orally for 50 weeks.
Intervention Type
Drug
Intervention Name(s)
use of sulodexide orally only
Other Intervention Name(s)
oral use of sulodexide
Intervention Description
Patients receive 1000 LSU per day orally for 52 weeks
Primary Outcome Measure Information:
Title
Change from Baseline in urine albumin/creatinine ratio
Description
conversion to normoalbuminuria and at least a 25% reduction in UACR opposed to baseline, or 50% reduction in UACR opposed to baseline
Time Frame
52th week since the commence of therapy
Secondary Outcome Measure Information:
Title
Change from Baseline in urine albumin/creatinine ratio and serum creatinine
Time Frame
before and 2nd,12th,24th,36th and 60th week since the commence of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanbing Li, PhD
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
endocrinology department of the first affiliated hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
20175052
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Citation
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.
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Citation
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.
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Effect of Sulodexide on Albuminuria in Chinese Type 2 Diabetic Patients

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