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| Name | Class |
|---|---|
| Alfasigma S.p.A. | INDUSTRY |
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The purpose of this study is to determine the effect and safety of Sulodexide in Filipino patients with Chronic Kidney Disease (CKD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo gelcaps + best medical treatment | Placebo Comparator | 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) |
|
| SLX 500LRU/day + best medical treatment | Active Comparator | 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) |
|
| SLX 1000LRU/day + best medical treatment | Active Comparator | 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) |
|
| SLX 2000LRU/day + best medical treatment | Active Comparator | 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulodexide | Drug | SLX 500 LRU, SLX 1000 LRU, SLX 2000 LRU per day to be taken orally for 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| macroalbuminuria and serum creatinine | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arlene C Crisostomo, M.D., MSc. | Contact | 639189004532 | arlene_crisostomo_md@yahoo.com | |
| Kathrina B Imperial | Contact | 6324487933 | 116 | kaye_imperial2004@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mary Mediatrix Medical Center | Lipa City | Batangas | Philippines |
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| placebo capsules | Drug | 8 soft-gel capsules per day to be taken orally for 12 months |
|
|
| Rizal Private Clinics | Metro Manila | Rizal | Philippines |
| Holy Child Hospital | Dumaguete | Philippines |
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| Victoriano R. Potenciano Medical Center | Mandaluyong | Philippines |
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| Metropolitan Medical Center | Manila | Philippines |
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| Manila Adventist Medical Center | Pasay | Philippines |
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| The Medical City | Pasig | Philippines |
|
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C007858 | glucuronyl glucosamine glycan sulfate |
| D006025 | Glycosaminoglycans |
| ID | Term |
|---|---|
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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