The Efficacy and Safety Study of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease (DEFINE)
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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
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Condition or disease | Intervention/treatment | Phase |
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Chronic Kidney Disease | Drug: Sulodexide Drug: placebo capsules | Phase 3 |
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 |

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)
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Drug: placebo capsules
8 soft-gel capsules per day to be taken orally for 12 months
Other Names:
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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)
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Drug: Sulodexide
SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.
Other Names:
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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)
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Drug: Sulodexide
SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.
Other Names:
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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)
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Drug: Sulodexide
SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months.
Other Names:
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- macroalbuminuria and serum creatinine [ Time Frame: 52 weeks ]
- adverse events [ Time Frame: 52 weeks ]

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

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
Contact: Arlene C Crisostomo, M.D., MSc. | 639189004532 | arlene_crisostomo_md@yahoo.com | |
Contact: Kathrina B Imperial | 6324487933 ext 116 | kaye_imperial2004@yahoo.com |
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 |
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 |
Diabetes Mellitus Chronic Kidney Disease Glycosaminoglycans |
Sulodexide Macroalbuminuria Safety and Efficacy |
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 |