Status:
COMPLETED
Effect of Sulodexide in Early Diabetic Nephropathy
Lead Sponsor:
Keryx Biopharmaceuticals
Collaborating Sponsors:
Collaborative Study Group (CSG)
Conditions:
Diabetic Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 mic...
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 charac...
Eligibility Criteria
Inclusion
- Diagnosis of type 2 diabetes
- Serum creatinine equal to or less than 1.5 mg/dL
- Microalbuminuria, defined by a urine albumin/creatinine ratio in men; 35- 200 mg albumin/G creatinine, in women; 45-200 mg albumin/G creatinine
- Blood pressure controlled to less than 150/90 mmHg
- Willing to change antihypertensive medication regimen if necessary
Exclusion
- Age of onset of type 2 diabetes \<18 years;
- HbA1C \>10.0%;
- Morbid obesity defined as a body mass index (BMI) \>= 45 kg/m2;
- Type 1 (insulin-dependent; juvenile onset) diabetes;
- Renal disease as follows:
- Patients with known non-diabetic renal disease
- Renal allograft
- Absolute requirement for combination therapy of angiotensin converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB);
- Cardiovascular disease as follows:
- Unstable angina pectoris within 3 months of study entry;
- Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty or stent placement within 3 months of study entry;
- Transient ischemic attack within 3 months of study entry;
- Cerebrovascular accident within 3 months of study entry;
- Symptomatic heart failure requiring ACE inhibition;
- New York Heart Association Functional Class III or IV heart failure;
- Obstructive valvular heart disease or hypertrophic cardiomyopathy;
- Second or third degree atrioventricular block not successfully treated with a pacemaker
- Need for chronic (\>2 weeks) immunosuppressive therapy, including corticosteroids (excluding inhaled or nasal steroids);
- History of multiple drug allergies;
- New diagnosis of cancer or recurrent cancer within 5 years of screening ( (except non-melanoma skin cancer);
- Psychiatric disorder that interferes with the patient's ability to comply with the protocol;
- Inability to tolerate oral medication or a history of significant malabsorption;
- Inability to remain on a stable dose of the following class of medications 30 days prior to randomization and throughout the study:
- 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins);
- Peroxisome proliferator-activated receptor gamma (PPAR gamma inhibitors (glitazones);
- Cyclooxygenase-2 inhibitors (COX-2 inhibitors); or
- Non-steroidal anti-inflammatory drugs (NSAIDS);
- History of alcohol or other drug abuse within 12 months of study entry;
- Known human immunodeficiency virus (HIV) disease;
- Any other medical condition which renders the patient unable to or unlikely to complete the study, or which would interfere with optimal participation in the study or produce significant risk to the patient;
- Receipt of any investigational drugs (including placebo) within 30 days of enrollment;
- Evidence of hepatic dysfunction including total bilirubin \>2.0 mg/dL or liver transaminase (AST or ALT) \>3 times upper limit of normal;
- Anticipated surgery within trial period;
- Inability to cooperate with study personnel or history of noncompliance to medical regimen (i.e., patients who would be expected to comply poorly with treatment);
- Known allergies or intolerance to any heparin-like compound;
- Untreated urinary tract infection that would impact urinary protein values; or
- Prior exposure to sulodexide, either in a clinical setting or as a participant in another clinical study.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
1056 Patients enrolled
Trial Details
Trial ID
NCT00130208
Start Date
August 1 2005
End Date
February 1 2008
Last Update
March 23 2018
Active Locations (3)
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1
The Collaborative Study Group, Clinical Coordinating Center for U.S. and Canadian Clinics, Rush University Medical Center
Chicago, Illinois, United States, 60612
2
The Collaborative Study Group, Clinical Coordinating Center for the Pacific Region, Monash Medical Center
Melbourne, Victoria, Australia, 3168
3
The Collaborative Study Group, Clinical Coordinating Center for European Clinics, University of Groningen
Groningen, Netherlands, 9713 AV