The Efficacy and Safety Study of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease (DEFINE)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Corbridge Group Philippines, Inc..
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Corbridge Group Philippines, Inc.
Collaborator:
Alfa Wassermann S.p.A.
Information provided by:
Corbridge Group Philippines, Inc.
ClinicalTrials.gov Identifier:
NCT01000545
First received: October 22, 2009
Last updated: October 29, 2009
Last verified: October 2009
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Purpose
The purpose of this study is to determine the effect and safety of Sulodexide in Filipino patients with Chronic Kidney Disease (CKD).
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Kidney Disease |
Drug: Sulodexide Drug: placebo capsules |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Corbridge Group Philippines, Inc.:
Primary Outcome Measures:
- macroalbuminuria and serum creatinine [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- adverse events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1508 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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:
|
|
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:
|
|
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:
|
Eligibility| Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
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: NCT01000545
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000545
Contacts
| 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
| Philippines | |
| Mary Mediatrix Medical Center | Not yet recruiting |
| Lipa City, Batangas, Philippines | |
| Principal Investigator: Edgardo Faustino, MD | |
| Rizal Private Clinics | |
| Metro Manila, Rizal, Philippines | |
| Holy Child Hospital | Not yet recruiting |
| Dumaguete City, Philippines | |
| Principal Investigator: Kenneth Coo | |
| Victoriano R. Potenciano Medical Center | Not yet recruiting |
| Mandaluyong City, Philippines | |
| Principal Investigator: Antonietta D Dial, M.D. | |
| Metropolitan Medical Center | Not yet recruiting |
| Manila, Philippines | |
| Principal Investigator: Susan Y Gan, MD | |
| Manila Adventist Medical Center | Not yet recruiting |
| Pasay City, Philippines | |
| Principal Investigator: Gingerlita Samonte, MD | |
| The Medical City | Not yet recruiting |
| Pasig City, Philippines | |
| Principal Investigator: Elizabeth R Sebastian, MD, FPSN | |
Sponsors and Collaborators
Corbridge Group Philippines, Inc.
Alfa Wassermann S.p.A.
More Information
| Responsible Party: | Mr. German A. Panghulan, Corbridge Group Philippines, Inc. |
| ClinicalTrials.gov Identifier: | NCT01000545 History of Changes |
| Other Study ID Numbers: | SLD-CKD-001 |
| Study First Received: | October 22, 2009 |
| Last Updated: | October 29, 2009 |
| Health Authority: | Philippines: Bureau of Food and Drugs Philippines: Philippine Council for Health Research and Development |
Keywords provided by Corbridge Group Philippines, Inc.:
|
Diabetes Mellitus Chronic Kidney Disease Glycosaminoglycans |
Sulodexide Macroalbuminuria Safety and Efficacy |
Additional relevant MeSH terms:
|
Renal Insufficiency, Chronic Kidney Diseases Renal Insufficiency Urologic Diseases 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 |
ClinicalTrials.gov processed this record on September 27, 2016