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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
ALFA WASSERMANN(BJ) Market Research and Management Co., Ltd
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01316068
First received: March 15, 2011
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetic Nephropathy
Albuminuria
Drug: intravenous use of sulodexide followed by oral use
Drug: use of sulodexide orally only
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Intravenous and Oral Therapy With Sulodexide on Albuminuria in Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Change from Baseline in urine albumin/creatinine ratio [ Time Frame: 52th week since the commence of therapy ] [ Designated as safety issue: No ]
    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 [ Time Frame: before and 2nd,12th,24th,36th and 60th week since the commence of therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Other Name: sequential use of sulodexide
Active Comparator: oral use of sulodexide
Patients allocated to oral group will received 1000 LSU per day orally for 52 weeks
Drug: use of sulodexide orally only
Patients receive 1000 LSU per day orally for 52 weeks
Other Name: oral use of sulodexide

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316068

Locations
China, Guangdong
endocrinology department of the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
ALFA WASSERMANN(BJ) Market Research and Management Co., Ltd
Investigators
Principal Investigator: Yanbing Li, PhD First Affiliated Hospital, Sun Yat-Sen University
  More Information

Publications:

Responsible Party: endocrinology department of the first affiliated hospital of Sun Yat-sen University, Yanbing Li
ClinicalTrials.gov Identifier: NCT01316068     History of Changes
Other Study ID Numbers: sulodexide20110311
Study First Received: March 15, 2011
Last Updated: March 15, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
diabetic nephropathy
albuminuria
type 2 diabetes
sulodexide

Additional relevant MeSH terms:
Albuminuria
Diabetic Nephropathies
Kidney Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Proteinuria
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Antimetabolites
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Hypoglycemic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014