The Efficacy and Safety Study of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease
NCT ID: NCT01000545
Last Updated: 2009-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1508 participants
INTERVENTIONAL
2009-11-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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)
placebo capsules
8 soft-gel capsules per day to be taken orally for 12 months
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)
Sulodexide
SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.
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)
Sulodexide
SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.
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)
Sulodexide
SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.
Interventions
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Sulodexide
SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.
placebo capsules
8 soft-gel capsules per day to be taken orally for 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* \+ renal disease like non-DM renal disease
* \+ CV diseases such as UA, MI, CABG
* \+ CVA or TIA within last 6 months
* untreated UTI
19 Years
ALL
No
Sponsors
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Alfasigma S.p.A.
INDUSTRY
Corbridge Group Philippines, Inc.
OTHER
Responsible Party
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Corbridge Group Philippines, Inc.
Locations
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Mary Mediatrix Medical Center
Lipa City, Batangas, Philippines
Rizal Private Clinics
Metro Manila, Rizal, Philippines
Holy Child Hospital
Dumaguete, , Philippines
Victoriano R. Potenciano Medical Center
Mandaluyong, , Philippines
Metropolitan Medical Center
Manila, , Philippines
Manila Adventist Medical Center
Pasay, , Philippines
The Medical City
Pasig, , Philippines
Countries
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Central Contacts
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Other Identifiers
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SLD-CKD-001
Identifier Type: -
Identifier Source: org_study_id