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Sponsors and Collaborators: |
Keryx Biopharmaceuticals The Collaborative Study Group |
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Information provided by: | Keryx Biopharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00130208 |
The purpose of the study is to determine whether treatment with sulodexide is effective in reducing the level of urine albumin excretion in patients with early diabetic kidney disease expressed as microalbuminuria.
Condition | Intervention | Phase |
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Diabetic Nephropathy |
Drug: Sulodexide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Collaborative Study Group Trial: The Effect of Sulodexide in Patients With Type 2 Diabetes and Microalbuminuria |
Estimated Enrollment: | 1000 |
Study Start Date: | August 2005 |
Study Completion Date: | February 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Diabetic nephropathy is an important cause of morbidity and mortality in patients with either type 1 or type 2 diabetes mellitus. The pathogenesis and natural history of diabetic nephropathy is characterized initially by microalbuminuria followed by a progressive decline in glomerular function. An emerging body of evidence supports the notion that glomerular capillary wall and mesangial alterations in diabetic nephropathy involve pathobiochemical alterations of glycoproteins in these structures. Evidence, in experimental animals rendered diabetic, reveals that the administration of heparin and other anionic glycoproteins (GAG) can effectively prevent the biochemical alterations which are responsible for albuminuria. Sulodexide, an orally active agent which does not have anticoagulant properties associated with its oral dose range, is comprised of three naturally occurring glycosaminoglycan (GAG) polysaccharide components isolated from porcine intestinal mucosa. Small clinical studies employing sulodexide, have shown that albuminuria is significantly diminished in patients with diabetic nephropathy, even when these patients are receiving angiotensin II receptor blockers (ARB) or angiotensin converting enzyme inhibitors (ACEI), agents already proven to reduce albuminuria and slow progressive diabetic nephropathy.
This study is designed to evaluate whether sulodexide is safe and effective in treating subjects with type 2 diabetic nephropathy. Subjects with type 2 diabetes and microalbuminuria (defined as a urinary albumin to creatinine ratio,(ACR)in men 35-200 mg/G and in women 45-200 mg/G) who are also receiving either irbesartan 300 mg/day, losartan 100 mg/day, or a maximum approved dose of an angiotensin receptor blocker (ARB) or angiotensin converting enzyme inhibitor (ACEI) will be enrolled in the study. The study will consist of the following periods:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Renal disease as follows:
Cardiovascular disease as follows:
Inability to remain on a stable dose of the following class of medications 30 days prior to randomization and throughout the study:
United States, Illinois | |
The Collaborative Study Group, Clinical Coordinating Center for U.S. and Canadian Clinics, Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
Australia, Victoria | |
The Collaborative Study Group, Clinical Coordinating Center for the Pacific Region, Monash Medical Center | |
Clayton / Melbourne, Victoria, Australia, 3168 | |
Netherlands | |
The Collaborative Study Group, Clinical Coordinating Center for European Clinics, University of Groningen | |
Groningen, Netherlands, 9713 AV |
Study Director: | Edmund J Lewis, M.D. | The Collaborative Study Group, Rush University Medical Center, Chicago, IL USA |
Principal Investigator: | Robert C Atkins, M.D. | The Collaborative Study Group, Monash Medical Center, Clayton, Victoria, AUSTRALIA |
Principal Investigator: | Dick deZeeuw, M.D. | The Collaborative Study Group, University of Groningen, NETHERLANDS |
Principal Investigator: | Itamar Raz, M.D. | The Collaborative Study Group, Hadassah University, Jerusalem, ISRAEL |
Study ID Numbers: | KRX-101-301 |
Study First Received: | August 11, 2005 |
Last Updated: | March 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00130208 History of Changes |
Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Austria: Federal Ministry for Health and Women; Belgium: Directorate general for the protection of Public health: Medicines; Canada: Health Canada; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; France: Ministry of Health; Hong Kong: Department of Health; Hungary: National Institute of Pharmacy; Ireland: Irish Medicines Board; Israel: Israeli Health Ministry Pharmaceutical Administration; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); New Zealand: Health and Disability Ethics Committees; Poland: Ministry of Health; Portugal: National Pharmacy and Medicines Institute; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Diabetes Diabetes Mellitus, Type 2 Albuminuria Diabetic Nephropathy |
Antimetabolites Diabetic Nephropathies Albuminuria Anticoagulants Glucuronyl glucosamine glycan sulfate Antilipemic Agents Diabetes Mellitus Endocrine System Diseases Fibrinolytic Agents |
Cardiovascular Agents Fibrin Modulating Agents Hypoglycemic Agents Urologic Diseases Diabetes Mellitus, Type 2 Kidney Diseases Endocrinopathy Diabetes Complications |
Antimetabolites Diabetic Nephropathies Anticoagulants Molecular Mechanisms of Pharmacological Action Glucuronyl glucosamine glycan sulfate Antilipemic Agents Physiological Effects of Drugs Hematologic Agents Diabetes Mellitus Endocrine System Diseases |
Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions Fibrin Modulating Agents Hypoglycemic Agents Urologic Diseases Therapeutic Uses Kidney Diseases Diabetes Complications |