PIMAGEDINE IN PATIENTS WITH TYPE II DIABETES MELLITUS AND DIABETIC NEPHROPATHY

吡马地定治疗 II 型糖尿病和糖尿病肾病患者

• 批准号: 6112952
• 负责人: JANET MCGILL
• 金额: $ 2.44万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6112952
• 关键词: aminoguanidine; clinical research; diabetes mellitus therapy; diabetic nephropathy; drug adverse effect; drug screening /evaluation; glomerular filtration; human subject; human therapy evaluation; kidney disorder chemotherapy; longitudinal human study; noninsulin dependent diabetes mellitus

This is a multicenter study which will be randomized, double-blind, and placebo-controlled. Patients with NIDDM and 24 degree protein excretion rate greater than 500 mg and a serum creatinine greater than 1.0mg/dl for women, 1.2 mg/dl for men, will be randomized to either placebo or one of two dose levels of pimagedine. The total duration of the study will be 4 yrs with an expected mean follow-up of 3 yrs. The study end-point will be doubling of serum creatinine, with secondary measures of decline of GFR by 131 I-iothalamate, mortality and other adverse events.

这是一项随机、双盲、安慰剂对照的多中心研究。 患有NIDDM且24度蛋白排泄率大于500 mg且女性血清肌酐大于1.0 mg/dl、男性大于1.2 mg/dl的患者将被随机分配至安慰剂组或两种剂量水平的匹马定组。 研究的总持续时间为4年，预期平均随访时间为3年。研究终点为血清肌酐加倍，次要指标为131 I-碘酞酸盐引起的GFR下降、死亡率和其他不良事件。