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

KERYX BIOPHARMACEUTICALS INC.0 个研究点目标入组 1,000 人开始时间: 2006年3月23日最近更新: 2012年4月18日

研究概览

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•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

•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

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