Phenylbutyrate Effect on Lcn2 Urianry Expression in Proteinuric Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Urinary Lcn2/creatinine ratio
研究概览
简要总结
The purpose of this study is to determine whether sodium phenylbutyrate can reduce Lcn2 urinary expression in proteinuric patients.
详细描述
Proteinuria is a major prognosis factor of chronic kidney disease (CKD) progression. Convergent evidences from clinical and experimental studies indicate that albuminuria and proteinuria are not simply a marker of CKD progression, but an active player in the evolution of the disease. Mechanistically, it has been shown that proteinuria induces endoplasmic reticulum stress in tubular cells, leading to induction of lipocalin 2/NGAL, a critical element of CKD progression. Moreover, proteinuric mice treated with phenylbutyrate are protected from CKD progression.
The aim of this study is to evaluate the efficacy of phenybutyrate, a molecular chaperone which inhibits ER stress, on the proteinuria-induced NGAL expression. Urinary NGAL/creatinine ratio will be evaluated in proteinuric patients before and under treatment with phenylbutyrate.
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
- None
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
- •Chronic Kidney disease for ore than 3 months
- •Proteinuria > 1g/d or 0,1g/mmmol creatinine
- •eGFR >30ml/mn/1,73m2
- •written informed consent
- •affiliated with social security health insurance
排除标准
- •Women with childbearing potential
- •Recent (<3 months) modification of ACE inhibitors or ARB
- •Acute renal failure
- •eGFR <30ml/mn/1,73m2
- •Nephrotic syndrome (albuminélia <30g/l)
- •Infection with HIV, HCV, HBV
- •Liver insufficiency
- •No affiliated with social security health insurance
- •inclusion in another protocol of biomedical research
- •risk of non-adherence to protocol and visits
- •patients having a cardiac insufficiency of grade 3 or 4
- •patient requiring of a strict salt-free diet
- •patients under corticoids or immunosuppresseurs
- •clinical intolerance in the treatment
- •intolerance in the fructose, the syndrome of malabsorption glucose and galactose or a deficit in sucrase / isomaltase
- •patients treated by Probenecide
研究组 & 干预措施
PBA 15g/d
Treatment for 14 days
干预措施: PBA 15g/d (Drug)
PBA 7,5g/d
Treatment for 14 days
干预措施: PBA 7,5g/d (Drug)
结局指标
主要结局
Urinary Lcn2/creatinine ratio
时间窗: Day 7, Day 15, Day 21, Day 28
Reduction of 50 % of Lcn2 concentration, measured with ELISA
次要结局
- Urinary protein/creatinine ratio(Day 28)