Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130312
Status:
TERMINATED
Last Update Posted:
2021-03-19
First Post:
2005-08-11
Brief Title:
Effect of Sulodexide in Overt Diabetic Nephropathy
Sponsor:
Keryx Biopharmaceuticals
Organization:
Keryx Biopharmaceuticals
Study Overview
Official Title:
The Collaborative Study Group Trial The Effect of Sulodexide in Overt Type 2 Diabetic Nephropathy
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No difference in protein excretion at 612 months No safety issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether sulodexide is effective in slowing or preventing the progression of diabetic kidney disease
Detailed Description:
Diabetes is now the most common cause of end-stage renal disease ESRD in the US and in many other developed nations Diabetic nephropathy now represents 44 of all new cases of ESRD in the US 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 In particular the incidence of type 2 diabetes mellitus DM2-related cases of ESRD is rapidly increasing From 1993 to 1997 71 of all diabetes-related ESRD was attributable to DM2 USRDS 1999 The earliest sign of diabetic kidney disease presents as microalbuminuria the spilling of small of amounts of blood protein into the urine Microalbuminuria correlates directly with the subsequent development of more advanced kidney disease Improved glycemic control and blood pressure control with the use of inhibitors of the renin-angiotensin-aldosterone system can reduce the level of microalbuminuria and overt proteinuria However despite these measures diabetic nephropathy continues to progress albeit more slowly Sulodexide belongs to a class of drugs called glycosaminoglycans GAG GAG therapy has been shown in animal models to prevent and or induce regression of albuminuria and the morphologic changes associated with progressive diabetic nephropathy such as glomerular basement thickening loss of the anionic charge density and mesangial collagen deposition Sulodexide is approved in Europe to treat vascular indications It has been utilized in several small phase II studies to treat early diabetic nephropathy inducing an additional 40-70 reduction in albuminuria in subjects whose albumin excretion was already reduced with tight glycemic control plus the use of inhibitors of the renin-angiotensin-aldosterone system for blood pressure control
The purpose of this study is to add to this body of evidence that Sulodexide may offer additional benefit in preventing or ameliorating more advanced diabetic nephropathy manifested as overt proteinuria and reduced GFR Subjects with type 2 diabetes moderately elevated serum creatinine and overt proteinuria will be treated with a standardized maximal recommendedtolerated dose of irbesartan 300 mgday or losartan 100 mgday plus additional concomitant non-ARB non-ACEi antihypertensive drugsfor up to 2-3 months to establish adequate and stable blood pressure control and urine protein excretion After establishing baseline serum creatinine and urine protein excretion they will be randomized to either Sulodexide 200 mgd or matching placebo Subjects will be seen every 3 months to monitor safety and efficacy parameters for up to 4 years The primary outcome is a doubling of baseline serum creatinine 50 loss of kidney function or end stage kidney disease ESRD
The purpose of this study is to add to this body of evidence that Sulodexide may offer additional benefit in preventing or ameliorating more advanced diabetic nephropathy manifested as overt proteinuria and reduced GFR Subjects with type 2 diabetes moderately elevated serum creatinine and overt proteinuria will be treated with a standardized maximal recommendedtolerated dose of irbesartan 300 mgday or losartan 100 mgday plus additional concomitant non-ARB non-ACEi antihypertensive drugsfor up to 2-3 months to establish adequate and stable blood pressure control and urine protein excretion After establishing baseline serum creatinine and urine protein excretion they will be randomized to either Sulodexide 200 mgd or matching placebo Subjects will be seen every 3 months to monitor safety and efficacy parameters for up to 4 years The primary outcome is a doubling of baseline serum creatinine 50 loss of kidney function or end stage kidney disease ESRD
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