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The Efficacy and Safety Study of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease (DEFINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01000545
Recruitment Status : Unknown
Verified October 2009 by Corbridge Group Philippines, Inc..
Recruitment status was:  Not yet recruiting
First Posted : October 23, 2009
Last Update Posted : October 30, 2009
Sponsor:
Collaborator:
Alfasigma S.p.A.
Information provided by:
Corbridge Group Philippines, Inc.

Study Description
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Brief Summary:
The purpose of this study is to determine the effect and safety of Sulodexide in Filipino patients with Chronic Kidney Disease (CKD).

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Sulodexide Drug: placebo capsules Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1508 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease: A Randomized Controlled Trial
Study Start Date : November 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: placebo gelcaps + best medical treatment
Patient will receive 4 placebo gelcaps twice a day. Best Medical Treatment (BMT)refers to the treatment currently acceptable and standard measures for the decrease in proteinuria. These are strict blood sugar control (HBA1c < 7.0%) and BP control (BP< 130/80)
 Drug: placebo capsules
8 soft-gel capsules per day to be taken orally for 12 months
Other Names:
  • placebo
  • placebo gelcaps
Active Comparator: SLX 500LRU/day + best medical treatment
Patient will receive 1 SLX gelcap and 3 placebo gelcaps twice a day.Best Medical Treatment (BMT)refers to the treatment currently acceptable and standard measures for the decrease in proteinuria. These are strict blood sugar control (HBA1c < 7.0%) and BP control (BP< 130/80)
 Drug: Sulodexide
SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.
Other Names:
  • Vessel Due-F
  • SLX
  • Glycosaminoglycans
Active Comparator: SLX 1000LRU/day + best medical treatment
Patient will receive 2 SLX gelcaps and 2 placebo gelcaps twice a day. Best Medical Treatment (BMT)refers to the treatment currently acceptable and standard measures for the decrease in proteinuria. These are strict blood sugar control (HBA1c < 7.0%) and BP control (BP< 130/80)
 Drug: Sulodexide
SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.
Other Names:
  • Vessel Due-F
  • SLX
  • Glycosaminoglycans
Active Comparator: SLX 2000LRU/day + best medical treatment
Patient will receive 4 SLX gelcaps twice a day. Best Medical Treatment (BMT)refers to the treatment currently acceptable and standard measures for the decrease in proteinuria. These are strict blood sugar control (HBA1c < 7.0%) and BP control (BP< 130/80)
 Drug: Sulodexide
SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.
Other Names:
  • Vessel Due-F
  • SLX
  • Glycosaminoglycans


Outcome Measures
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Primary Outcome Measures :
  1. macroalbuminuria and serum creatinine [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. adverse events [ Time Frame: 52 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • positive 2 of 3 ACR > 300 mg/g or 24h urine protein or albumin collection > 300 mg/d in the absence of urinary tract infection
  • serum creatinine 1.3 - 3 mg/dl in women and 1.5 - 3 mg/dl in men

Exclusion Criteria:

  • age of onset of DM \< 18 years
  • + renal disease like non-DM renal disease
  • + CV diseases such as UA, MI, CABG
  • + CVA or TIA within last 6 months
  • untreated UTI
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000545


Contacts
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Contact: Arlene C Crisostomo, M.D., MSc. 639189004532 arlene_crisostomo_md@yahoo.com
Contact: Kathrina B Imperial 6324487933 ext 116 kaye_imperial2004@yahoo.com

Locations
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Philippines
Mary Mediatrix Medical Center
Lipa City, Batangas, Philippines
Principal Investigator: Edgardo Faustino, MD         
Rizal Private Clinics
Metro Manila, Rizal, Philippines
Holy Child Hospital
Dumaguete City, Philippines
Principal Investigator: Kenneth Coo         
Victoriano R. Potenciano Medical Center
Mandaluyong City, Philippines
Principal Investigator: Antonietta D Dial, M.D.         
Metropolitan Medical Center
Manila, Philippines
Principal Investigator: Susan Y Gan, MD         
Manila Adventist Medical Center
Pasay City, Philippines
Principal Investigator: Gingerlita Samonte, MD         
The Medical City
Pasig City, Philippines
Principal Investigator: Elizabeth R Sebastian, MD, FPSN         
Sponsors and Collaborators
Corbridge Group Philippines, Inc.
Alfasigma S.p.A.
More Information
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Responsible Party: Mr. German A. Panghulan, Corbridge Group Philippines, Inc.
ClinicalTrials.gov Identifier: NCT01000545    
Other Study ID Numbers: SLD-CKD-001
First Posted: October 23, 2009    Key Record Dates
Last Update Posted: October 30, 2009
Last Verified: October 2009
Keywords provided by Corbridge Group Philippines, Inc.:
Diabetes Mellitus
Chronic Kidney Disease
Glycosaminoglycans
 Sulodexide
Macroalbuminuria
Safety and Efficacy
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs