Randomized, Double-blind, Placebo-controlled Trial of Niaspan® in Patients With Overt Diabetic Nephropathy and Moderate Renal Impairment
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in Proteinuria
研究概览
简要总结
The primary purpose of this study is to test the effectiveness and tolerability of Niaspan® to improve the levels of blood fats ("good" and "bad" cholesterol and triglyceride levels) in people who have kidney damage due to diabetes. A secondary goal is to test whether Niaspan® slows down further development of kidney damage.
详细描述
Diabetic nephropathy is the leading cause of end stage kidney disease in the United States. Patients with chronic kidney disease have a markedly increased risk of death from cardiovascular disease, and traditional risk factors such as hyperlipidemia have been shown to be of critical importance. Almost 90% of patients with diabetes and chronic kidney disease have lipid abnormalities. Here, we investigate whether Niaspan, taken in addition to lipid-lowering drugs referred to as "statins", will decrease LDL cholesterol and increase LDL particle size, increase HDL, reduce proteinuria, and reduce the speed of loss of renal function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes
- •Diagnosis of chronic kidney disease stage 2 or 3 with an estimated GFR of 30-89 ml/min using the four variable MDRD (Modification of Diet in Renal Disease Study Group) formula
- •Presence of microalbuminuria or proteinuria less than 3.5 g/d
- •Diagnosis of hyperlipidemia currently treated with a "statin" drug
排除标准
- •Not meeting inclusion criteria
- •HDL-C > 40 mg/dL for men, > 50 mg/dL for women
- •TG (triglycerides) < 150 mg/dL and > 800 mg/dL
- •Documented intolerance to Niaspan or Aspirin
- •Treatment with other lipid-lowering agents (fibrates, BAS [bile acid sequestrants], or ezetimibe)
- •Elevated transaminases (AST or ALT >1.3 x ULN)
- •Unstable type 2 diabetes (FBG >200 mg/dL or HbA1c >9.5%)
- •Known seropositivity for Hepatitis B, C, or HIV
- •Documented history of malignancy
- •Age < 18 years
- •Pregnant women or nursing mothers
- •Inability to give informed consent
- •Start or change in "statin" dose < 2 months ago
研究组 & 干预措施
Placebo
Placebo tablets
干预措施: Placebo (Other)
Extended release niacin
Extended release niacin 1500-2000 mg daily versus placebo comparator
干预措施: Extended release niacin (Drug)
结局指标
主要结局
Change in Proteinuria
时间窗: Baseline, 1 year
次要结局
未报告次要终点
研究者
Ronald Goldberg
Professor of Medicine
University of Miami