THE COLLABORATIVE STUDY GROUP TRIAL THE EFFECT OF SULODEXIDE IN PATIENTS WITH TYPE 2 DIABETES AND MICROALBUMINURIA - Micro

• Conditions: men and women with type 2 diabetes and persistent microalbuminuria; MedDRA version: 6.1Level: PTClassification code 10061835

• Registration Number: EUCTR2005-003158-91-IT
• Lead Sponsor: KERYX BIOPHARMACEUTICALS INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-23
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

men and women with type 2 diabetes and persistent microalbuminuria in men urine albumin creatinine ratio ACR 35 200 mg albumin/g creatinine 4.0 - 22.6 mg/mmol , in women urine ACR 45 200 mg albumin/g creatinine 5.1 22.6 mg/mmol based on the geometric mean of 3 first voided AM urine samples at the qualifying visit Visit 6 will be randomized. Patient s serum creatinine must be less than or equal to 1.5 mg/dL at screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Age of onset of type 2 diabetes 18 years; 2. HbA1C 10.0 ; 3. Morbid obesity defined as a body mass index BMI more than or equal to 45 kg/m2; 4. Type 1 insulin-dependent; juvenile onset diabetes; 5. patients with known non-diabetic renal disease, Renal allograft; 6. Absolute requirement for combination therapy of ACEI and ARB; 7. Cardiovascular disease 8. Need for chronic 2 weeks immunosuppressive therapy, 9. cancer 10. 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 61543; 61481; inhibitors glitazones ; Cyclooxygenase-2 inhibitors COX-2 inhibitors ; or Non-steroidal anti-inflammatory drugs NSAIDS ; 11. Known human immunodeficiency virus HIV disease; 12. Evidence of hepatic dysfunction including total bilirubin 2.0 mg/dL or liver transaminase AST or ALT 3 times upper limit of normal; 13. Untreated urinary tract infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified