Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130208
Status:
COMPLETED
Last Update Posted:
2018-03-23
First Post:
2005-08-11
Brief Title:
Effect of Sulodexide in Early Diabetic Nephropathy
Sponsor:
Keryx Biopharmaceuticals
Organization:
Keryx Biopharmaceuticals
Study Overview
Official Title:
The Collaborative Study Group Trial The Effect of Sulodexide in Patients With Type 2 Diabetes and Microalbuminuria
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 ratioACRin men 35-200 mgG and in women 45-200 mgG who are also receiving either irbesartan 300 mgday losartan 100 mgday 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
Screening of 1-2 weeks for assessing basic eligibilityexclusion criteria
Run-in of up to 16 weeks on maximal dose of ARB or ACE with stable blood pressure control
Qualifying visit qualifying patients are on maximal dose of ARB or ACE for a minimum of 4 months with stable BP control SBP 150 mmHg DBP 90 mmHg and albumin to creatinine ratio ACR between in men 35-200 mgG and in women 45-200 average of 3 first morning voids
Randomization patients are randomized to sulodexide 100 mg or matching placebo administered orally twice a day
Maintenance 26 week maintenance period with 4 visits to monitor safety and ACR
Washout Period 8 week washout period with 2 visits to monitor safety and ACR
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 ratioACRin men 35-200 mgG and in women 45-200 mgG who are also receiving either irbesartan 300 mgday losartan 100 mgday 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
Screening of 1-2 weeks for assessing basic eligibilityexclusion criteria
Run-in of up to 16 weeks on maximal dose of ARB or ACE with stable blood pressure control
Qualifying visit qualifying patients are on maximal dose of ARB or ACE for a minimum of 4 months with stable BP control SBP 150 mmHg DBP 90 mmHg and albumin to creatinine ratio ACR between in men 35-200 mgG and in women 45-200 average of 3 first morning voids
Randomization patients are randomized to sulodexide 100 mg or matching placebo administered orally twice a day
Maintenance 26 week maintenance period with 4 visits to monitor safety and ACR
Washout Period 8 week washout period with 2 visits to monitor safety and ACR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None