Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Evaluate the results of the use of Pirfenidone in the progression of renal damage in patients with Chronic Kidney Disease.
研究概览
简要总结
The aim of this study was to evaluate the impact in safety and efficacy of a new formulation of prolonged-released Pirfenidone in the progression of renal damage in patients with Chronic kidney Disease (CKD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between 10 and 40 years old with CKD
- •Diagnosis of CKD stage 1 to 4 according with KDIGO definition and classification
- •No glucocorticoids, cyclophasphamide, mycophenolate, or other immunosuppressive drugs for at least two months before starting PFD administration
- •Sign of consent forms
排除标准
- •Known intolerance to PFD
- •CKD stage V according with KDOQI classification
- •Post-transplant patients
- •History of peptic ulcer within six months
- •History of cerebrovascular disease within six months
- •Evidence of hepatic disease
- •Pregnancy or breast feeding
研究组 & 干预措施
Pirfenidone
Pirfenidone 1200 mg in the form of prolonged-released tablets, orally administered two times a day (b.i.d.) to yield a daily dose of 2400 mg during three years.
干预措施: Pirfenidone (Drug)
结局指标
主要结局
Evaluate the results of the use of Pirfenidone in the progression of renal damage in patients with Chronic Kidney Disease.
时间窗: three years
The progression of renal damage in patients with Chronic Kidney Disease was evaluated according to stages 1-4 of classification KDIGO.
次要结局
- Effect of the use of Pirfenidone in renal function(Three years)
研究者
Juan Armendáriz-Borunda
Head, Molecular Biology and Genomics Departament, CUCS
University of Guadalajara