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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: | NCT00462202 |
The purpose of this study is to assess the tolerability and safety of KRX-101 in treating persistent microalbuminuria in type 2 diabetic patients who are also being treated with stable, maximum tolerated doses of either ACE inhibitors or A2 receptor blockers.
Condition | Intervention | Phase |
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Diabetic Nephropathy |
Drug: sulodexide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | An Open Label Tolerability and Safety Study of KRX-101 (Sulodexide Gelcaps) for the Treatment of Type 2 Diabetic Nephropathic Patients With Persistent Microalbuminuria in Australia, New Zealand, and Hong Kong |
Estimated Enrollment: | 200 |
Study Start Date: | April 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Diabetes is one of the most common causes of end-stage renal disease (ESRD) in the U.S. and in many other developed nations. Despite advances in clinical care, including improvements in glycemic and blood pressure control, the number of new cases of diabetes-related ESRD continues to rise, especially in patients with type 2 diabetes.
The current standard of care for the prevention and treatment of diabetic renal disease includes screening all diabetic patients for microalbuminuria. Patients who test positive for microalbuminuria are then treated with either ACE inhibitors or A2 receptor blockers. Both of these classes of medication have been shown to reduce levels of microalbuminuria in some patient populations. This improvement in microalbuminuria has also shown a delay of progression to a number of other renal function problems, as well as a minimal delay in certain clinical events including ESRD.
Unfortunately, some patients achieve the majority of their therapeutic effect of ACE inhibitors or A2 receptor blockers within the first 6 months of therapy, and many of these patients continue to show persistent microalbuminuria. Therefore, these patients are at an increased risk of progressing to ESRD due to the lack of adequate benefit from their current medication.
Microalbuminuria has a straight-line relationship with adverse renal outcomes; therefore any level of reduction may have clinical benefit. It is reasonable to believe that patients who can reduce or have a complete remission of their microalbuminuria may also lessen the risk of progressing to ESRD. Thus, if KRX-101 is able to cause a reduction or complete remission of microalbuminuria to normoalbuminuria, patients may receive a significant clinical benefit.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, Victoria | |
Monash Medical Center | |
Melbourne, Victoria, Australia, 3168 |
Study Director: | Robert Atkins, MD | Monash University |
Principal Investigator: | Anne Reutens, MD | Monash Medical Center |
Study ID Numbers: | KRX 101-302 |
Study First Received: | April 16, 2007 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00462202 |
Health Authority: | United States: Food and Drug Administration; Australia: Human Research Ethics Committee; New Zealand: Medsafe; Hong Kong: Department of Health |
Diabetes Microalbuminuria Proteinuria Albuminuria KRX-101 |
Sulodexide Nephropathy Keryx Collaborative Study Group Diabetic nephropathy with persistent microalbuminuria |
Proteinuria Albuminuria Diabetic Nephropathies Urologic Diseases Glucuronyl glucosamine glycan sulfate |
Diabetes Mellitus Endocrine System Diseases Endocrinopathy Kidney Diseases Diabetes Complications |
Antimetabolites Fibrin Modulating Agents Hypoglycemic Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Antilipemic Agents |
Therapeutic Uses Physiological Effects of Drugs Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |