The effect of sulodexide in overt type 2 diabetic nephropathy. - Overt

KERYX BIOPHARMACEUTICALS INC.0 个研究点目标入组 2,240 人开始时间: 2006年3月20日最近更新: 2012年4月24日

适应症

试验速览

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•The population for this study includes women and men with type 2 diabetes and clinically overt proteinuria protein creatinine ratio PCR the geometric mean of 3 AM first voided urine of 61619;900 mg/G 101.7 mg/mmol for women and 61619;650 mg/G 73.45 mg/mmol for men . In addition, serum creatinine in women must be between 1.3 and 3.0 mg/dL 115 265 956;mol/L , inclusive, and in men between 1.5 and 3.0 mg/dL 133-265 956;mol/L , inclusive. If the serum creatinine falls outside the specified creatinine criteria, a patient may enter the Run-in Period only if the glomerular filtration rate GFR is between 25 and 61472;45 mL/min, as calculated by the Modification of Diet in Renal Disease MDRD formula.
•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

•Type I diabetes, known non-diabetic renal disease, renal allograft, need for a combination of ACEI and ARB, cardiovascular disease, need for chronic immunosuppressive treatement, cancer, HIV, evidence of hepatic disfunction, untreated urinary tract infection.

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