Effect of Sulodexide in Early Diabetic Nephropathy

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetic Nephropathy

In brief

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.

Key facts

Study ID

NCT00130208

Run by

Keryx Biopharmaceuticals

People needed

1056

Starts

2005-08-01

Expected to finish

2008-02-01

Last updated by the study team

2018-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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);

Where it is running

• The Collaborative Study Group, Clinical Coordinating Center for U.S. and Canadian Clinics, Rush University Medical Center — Chicago, Illinois, United States
• The Collaborative Study Group, Clinical Coordinating Center for the Pacific Region, Monash Medical Center — Melbourne, Victoria, Australia
• The Collaborative Study Group, Clinical Coordinating Center for European Clinics, University of Groningen — Groningen, Netherlands

Full record on ClinicalTrials.gov

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