NCT00214721已完成3 期
A Study to Evaluate the Efficacy and Safety of an Experimental Solution for Peritoneal Dialysis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
研究概览
简要总结
Objective: The purpose of this study is to demonstrate:
-the non-inferiority of an experimental peritoneal dialysis solution compared to a current solution for the management of end stage renal disease (ESRD) in peritoneal dialysis patients.
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
- •Patients who have given written informed consent after the nature of the study has been explained.
- •Patients who are at least 18 years of age.
- •Patients who have been treated with CAPD using specific solutions for at least 60 days before the baseline visit.
排除标准
- •Patients who have received antibiotics for the treatment of an episode of peritonitis within 30 days before the screening visit. - Patients who have had acute or chronic exit-site or tunnel infection in the past 14 days, counted from the last day of infection to the screening visit.
- •Patients who have other serious diseases, such as active, or if previously treated, residual malignancy or systemic infection.
- •Patients who have had a major illness or injury requiring hospitalisation within 30 days before the baseline visit.
- •Patients who have severe malnutrition (serum albumin < 25 g/l by bromocresol green method).
- •Patients who are participating in another study that requires Ethics Committee approval. Non-interventional studies are permitted.
- •Patients who have received an investigational product within 30 days preceding the screening visit.
- •Patients who are pregnant or lactating. (NB: Female patients of childbearing potential must have a negative urine or serum pregnancy test at the time of the screening and will be required to use a medically acceptable means of contraception during their participation in this study).
- •Patients who have a significant psychiatric disorder or mental disability that could interfere with his/her ability to provide informed consent and/or comply with protocol procedures.
研究者
研究点 (2)
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