Pirfenidone: A Novel Anti-Scarring Therapy for Diabetic Nephropathy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 3
- 主要终点
- The primary endpoint will be the change in renal function from baseline to the end of the study period (12 months).
研究概览
简要总结
The purpose of this study is to determine whether a new investigational drug, pirfenidone, will be an effective therapy for diabetic patients with kidney dysfunction. Our hypothesis is that administration of pirfenidone to type 1 and type 2 diabetic patients with advanced kidney disease will lead to preservation of kidney function.
详细描述
Diabetic kidney disease is the leading cause of new cases of kidney failure in the United States. In the kidneys of diabetic patients, there is accumulation of protein that leads to the formation of scar tissue and poor kidney function. Because of this many patients eventually require dialysis or kidney transplantation. A new investigational drug, pirfenidone, has been shown to be beneficial in a number of diseases in which scar formation leads to disease progression. It is our goal to examine whether pirfenidone is effective at stabilizing or reducing progressive diabetic kidney dysfunction.
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
- Triple (Participant, Care Provider, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo
干预措施: Pirfenidone (Drug)
Pirfenidone 1200 mg/day
Pirfenidone will be administered at a dose of 1200 mg/day
干预措施: Pirfenidone (Drug)
Pirfenidone 2400 mg/day
Pirfenidone will be administered at 2400 mg/day
干预措施: Pirfenidone (Drug)
结局指标
主要结局
The primary endpoint will be the change in renal function from baseline to the end of the study period (12 months).
时间窗: 12 months
次要结局
- % change in urine albumin excretion from baseline to end of study period.(12 months)
- % change in levels of TGF-b1 in urine, plasma and serum from baseline to end of study period.(12 months)
- • Determine the relationship between % change in TGF-b1 levels and the change in GFR(12 months)