Effect of Ursodeoxycholic Acid on Peritoneal Function in Patients on Peritoneal Dialysis
试验速览
- 阶段
- 4 期
- 入组人数
- 55
- 主要终点
- Peritoneal membrane function
研究概览
简要总结
Peritoneal fibrosis is one of the major causes of technical failure in patients on peritoneal dialysis (PD) for long period of time. Although the exact mechanisms of peritoneal damage during PD still remain unclear, generation of Endoplasmic reticulum (ER) stress may be responsible for progressive membrane dysfunction. Ursodeoxycholic acid (URSA) is a powerful inhibitor of ER stress to protect peritoneal fibrosis in peritoneal dialysis in the investigators in-vitro study. In this study the researchers investigated the hypothesis that URSA protect peritoneal membrane damage.
详细描述
Ursodeoxycholic acid (URSA) is known to be relatively safe and beneficial in peritoneal dialysis patient at a dose of 300 mg per day. Patients will be randomly assigned to URSA and placebo group and prescribed according to the protocol. At 2 and 6 month, Peritoneal equilibrium test (PET) will be performed with blood sampling.
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
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Maintenance peritoneal dialysis at least 3 months
- •Patients who are able and willing to understand, sign and date an informed consent document, and authorize access to protected health information
排除标准
- •Episode of peritonitis at least 3 months
- •Episodes of admission due to other disease at lease 3 months
- •Liver disease
- •Allergic history with Ursodeoxycholic acid
- •Nausea or vomiting after Ursodeoxycholic acid
研究组 & 干预措施
URSA group
Drug: Ursodeoxycholic acid Other Name: URSAⓇ (Daewoong Pharmaceutical Co., Ltd) Ursodeoxycholic acid (100 mg/tablet) 300 mg/day ( 100mg tid) for 6 months 3 times after meal
干预措施: Ursodeoxycholic Acid (Drug)
结局指标
主要结局
Peritoneal membrane function
时间窗: 6 months
Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test
次要结局
- Residula renal function(6 months)
- Epithelial to Mesenchymal Transition, EMT(6 months)
- Oxydative stress(6 months)
研究者
Duk-Hee Kang
Professor
Ewha Womans University