Effect of Sulodexide in Early Diabetic Nephropathy
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|ClinicalTrials.gov Identifier: NCT00130208|
Recruitment Status : Completed
First Posted : August 15, 2005
Results First Posted : March 23, 2018
Last Update Posted : March 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Nephropathy||Drug: Sulodexide Drug: Placebo||Phase 3|
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:
- Screening: of 1-2 weeks for assessing basic eligibility/exclusion 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 mg/G 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1056 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Collaborative Study Group Trial: The Effect of Sulodexide in Patients With Type 2 Diabetes and Microalbuminuria|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||February 2008|
Also known as KRX-101. All patients will be on standard of care ACE or ARBs.
100 mg sulodexide gelcaps
Other Name: KRX-101
Placebo Comparator: Placebo
All patients will be on standard of care ACE or ARBs.
0 mg gelcap
Other Name: Placebo oral gelcap
- Number of Subjects With Conversion From Microalbuminuria to Normoalbuminuria [ Time Frame: 26 Weeks ]The primary efficacy variable was the fraction of those patients in the ITT population with valid baseline and Week 26 ACRs in whom "therapeutic success" was achieved at Week 26 measured as a conversion of microalbuminuria to normoalbuminuria and at least a 25% reduction in ACR relative to baseline
- Number of Subjects With Greater Than 50% Reduction in Microalbuminuria [ Time Frame: 26 Weeks ]During the treatment period, KRX-101 is being compared to placebo to assess whether a 50% reduction in microalbuminuria has been achieved.
- Change in Serum Albumin From Baseline to End of 26 Weeks [ Time Frame: 26 Weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130208
|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|
|The Collaborative Study Group, Clinical Coordinating Center for the Pacific Region, Monash Medical Center|
|Melbourne, Victoria, Australia, 3168|
|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|