Clinical Trial: Effect of Sulodexide in Overt Diabetic Nephropathy

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: The Collaborative Study Group Trial: The Effect of Sulodexide in Overt Type 2 Diabetic Nephropathy

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 Summary:

Diabetes is now the most common cause of end-stage renal disease (ESRD) in the U.S. and in many other developed nations. Diabetic nephropathy now represents 44% of all new cases of ESRD in the U.S. 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 tha
Sponsor: Keryx Biopharmaceuticals

Current Primary Outcome:

  • Time to doubling of the serum creatinine or end stage kidney disease (ESRD) [ Time Frame: Time in study depended on time to doubling of serum creatinine ]
    Time in study depended on time to doubling of serum creatinine and when the patient was enrolled in the trial.
  • Safety and tolerance of sulodexide therapy long-term [ Time Frame: Time in study depended on time to doubling of serum creatinine ]
    Review of laboratory parameters, adverse events, physical examinations, etc. were made to evaluate patient safety.


Original Primary Outcome:

  • - Time to doubling of the serum creatinine or ESRD
  • - Safety and tolerance of sulodexide therapy long-term


Current Secondary Outcome: Change in urinary protein/albumin excretion [ Time Frame: Time in study depended on time to doubling of serum creatinine ]

Review of urinary protein and albumin excretion was made as an additional assessment of kidney function.


Original Secondary Outcome: - Change in urinary protein / albumin excretion

Information By: Keryx Biopharmaceuticals

Dates:
Date Received: August 11, 2005
Date Started: August 2005
Date Completion:
Last Updated: April 13, 2015
Last Verified: April 2015